Appendicitis AcuteOSAENCT03723642
Investigation of Oxidative Stress in Appendectomy - Open Versus Laparoscopic in Childhood and Adolescence
A study testing Initial serum malondialdehyde level, Final serum malondialdehyde level and Initial differential white blood cell count in people with Appendicitis Acute, run by Medical University of Graz at 1 site in Austria.
Trial summary
In the planned prospective randomized study, oxidative stress will be investigated by analyzing volatile organic compounds in the exhaled air in children. Children who have undergone open versus laparoscopic surgery for appendicitis will be compared. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Appendicitis Acute
- What is being tested?
- Initial serum malondialdehyde level, Final serum malondialdehyde level and Initial differential white blood cell count
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 2 Oct 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age from 6-18 years
- reliable diagnosis of acute appendicitis
- surgical therapy using open/laparoscopic surgical technique
- given approval
Who cannot join
- Age not between 6 and 18 years
- chronic underlying disease/autoimmune disease
- complicated appendicitis (perforation, consecutive purulent peritonitis, abscess formation)
- infection outside acute appendicitis
- SIRS
- taking medications containing the cytochrome P450 (CYP) system affect including cortisone
- impaired liver function
- unaccepted consent
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Paediatric and Adolescent Surgery
Graz, 8036
About this study
Official title: Investigation of Oxidative Stress - Open Appendectomy (OAE) Versus Laparoscopic Appendectomy (LAE) in Childhood and Adolescence - A Pilot Study
In the planned prospective randomized study, oxidative stress will be investigated by analyzing volatile organic compounds in the exhaled air in children. Children who have undergone open versus laparoscopic surgery for appendicitis will be compared. A better understanding of the effects of the surgical technique could be a prerequisite for an optimized surgical setting. It could also lead to recommendations for pre- or perioperatively antioxidative agents.
Read the detailed description
Aim of the study: In the planned prospective randomized study, oxidative stress will be investigated by analyzing VOCs (volatile organic compounds) in the exhaled breath in children undergoing open or laparoscopic surgery for appendicitis at the Department of Pediatric and Adolescent Surgery of the Medical University of Graz. A resulting better understanding of the effects of the surgical technique can a) be a pre-condition for an optimized surgical setting and b) possibly lead to recommendations of pre- or perioperatively antioxidatively active substances and c) be a base for future surgical procedures.
Study design: This is a prospective randomized pilot study in children and adolescents undergoing surgery due to acute appendicitis. Patients with complicated appendicitis and those with an intraoperatively caused disorder will be excluded. The operation within the context of this study is exclusively conducted by specialists of the Department of Pediatric and Adolescent Surgery of the Medical University of Graz, who perform both - open and laparoscopic surgical techniques. 40 patients aged 6-18 years suffering from acute appendicitis are to be included. These are divided into 2 groups. Group 1 (n = 20) with laparoscopic and group 2 (n = 20) with open appendectomy.
Recruitment and compensation of study participants: Parents/patients are made aware of the study by means of an information sheet and are provided with a declaration of consent if interested. Participants do not receive any compensation for participating in the study.
Sampling of exhaled VOCs (volatile organic compounds) using NTME (needle trap microextraction) for measurement OS (oxidative stress): Number of samples: 2 samples each from exhaled breath at the times defined below (in total n = 12). The time of sampling: t1 before anaesthetic introduction (n = 2); t2 after anesthetic introduction (n = 2); t3 15 minutes after cut (n = 2); t4 30 minutes after cut (n = 2); t5 45 minutes after cut (n = 2); t6 after seam (n = 2).
Analysis of exhaled VOCs for measurement OS: The exhaled breath samples taken are placed in an injector of a gas chromatograph into the inert carrier gas stream (He). The substances are assigned according to their retention time in the chromatogram and its mass spectrum. Unknown connections in the mass spectrum of exhaled breath is used as a basis for comparison with a reference database.
Sampling of blood markers for measurement OS: a) sampling times for WBCs, CRP: t1 = 1 sample preoperatively (before anaesthetic introduction) and t2 = 1 sample after 24 h. b) sampling times for malondialdehyde: t1 = 1 sample before anaesthetic introduction and t2 = 1 sample after suture.
Histopathological grading: The explanted vermiform appendix becomes the histopathological Refurbishment at the Institute of Pathology of the Medical University of Graz. There the classification is made according to the histopathological findings in 4 degrees of severity (acute focal appendicitis, acute suppurative appendicitis, acut gangrenous appendicitis, perforated appendicitis).
Sampling WBCs, CRP: These are carried out within the scope of routine diagnostics due to the clinical presentation of the AA (acute appendicitis).
Sampling VOCs: 2 breath samples are taken from each patient during expiration, taken from it. To collect the samples, the investigators use an automatic Sampling device connected directly to a capnometer. This system works with microextraction (NTME) and enables a automatic sampling of the alveolar air, i.e. in the plateau of the CO2 curve. The samples are sent to the Intitute of Rostock Medical Breath Analysis and Technologies (RoMBAT) as cooperation partner. This partner was selected because it already has extensive experience with the methodology and studies on oxidative stress during operations.
Malondialdehyde (MDA) sampling: Malondialdehyde is analysed at the Clinical Institute for Medical and Chemical Laboratory Diagnostics at the Medical University of Graz means of ultra-modern GC-MS method. For this purpose, the patient is assigned to the two Measuring times 2 x 400 μl EDTA plasma taken. The second sample serves only as a safety measure if repeat measurements are necessary. The samples obtained must be deep-frozen at -80 °C within 2 hours. . Subsequently (at the latest on the following day) the samples must be analyzed to the Institute.
Planned evaluation: The statistical investigations are carried out with SPSS 23.0®. Graphical representation of the data is performed with GraphPad Prism 7®. To investigate whether the main target variables (VOCs) differ in the course between the two groups, linear models are used for repeated measurements with group (open versus laparoscopic appendectomy) as intermediate subject factor and time of measurement (t1 to t6) as internal subject factor. In the case of deviations from the normal distribution, transformations are taken into consideration. The secondary targets, i.e. the changes in the serum markers on theTimes t1 and t6, are compared between the 2 groups (open versus laparoscopic appendectomy) by Mann-Whitney U-test (data not normally distributed) or independent T-test (with normal distribution). In order to establish relationships between the VOCs and the serum markers for oxidative stress at times t1 and t6 a correlation analysis is performed (depending on the data, Pearson or Spearman Rho). All statistical tests are carried out on two sides and all p-values are interpreted purely exploratively.
- Conditions
- Appendicitis Acute
- Being tested
- Initial serum malondialdehyde level, Final serum malondialdehyde level, Initial differential white blood cell count, Final differential white blood cell count, Initial c-reactive protein serum level
- Keywords
- acute appendicitis, volatile organic compounds, oxidative stress, laparoscopic appendectomy, open appendectomy
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial serum malondialdehyde levelDiagnostic test
Blood sample (0.4ml) will be obtained within 5 minutes before induction of general anaesthesia.
Samples will be obtained in both groups (LAE and OAE)
Final serum malondialdehyde levelDiagnostic test
Blood sample (0.4ml) will be obtained within 5 minutes after wound closure. Samples will be obtained in both groups (LAE and OAE)
Initial differential white blood cell countDiagnostic test
Differential blood counts (microscopic) will be obtained during pre-operative routine work-up.
Samples will be obtained in both groups (LAE and OAE).
Final differential white blood cell countDiagnostic test
Differential blood counts (microscopic) will be obtained 24h after the first sample (Initial differential blood count).
Samples will be obtained in both groups (LAE and OAE).
Initial c-reactive protein serum levelDiagnostic test
C-reactive protein levels will be obtained during pre-operative routine work-up.
Samples will be obtained in both groups (LAE and OAE).
Final c-reactive protein serum levelDiagnostic test
C-reactive protein levels will be obtained 24h after the first sample (initial c-reactive protein level).
Samples will be obtained in both groups (LAE and OAE).
Initial VOCDiagnostic test
Volatile organic compound sampling (2 samples within 5 minutes) within 10 minutes before induction of general anesthesia
VOC 5minDiagnostic test
Volatile organic compound sampling (2 samples within5 minutes) within 5 minutes after endotracheal intubation before skin incision.
VOC 15minDiagnostic test
Volatile organic compound sampling (2 samples within 5 minutes) 15 minutes after skin incision.
VOC 30minDiagnostic test
Volatile organic compound sampling (2 samples within 5 minutes) 30 minutes after skin incision.
VOC 45minDiagnostic test
Volatile organic compound sampling (2 samples within 5 minutes) 45 minutes after skin incision.
Final VOCDiagnostic test
Volatile organic compound sampling (2 samples within 5 minutes) within 5 minutes after skin closure.
| Study group | Role | What they receive |
|---|---|---|
| OAE group | Active comparator | All patients will undergo measurements of oxydative stress (initial serum malondialdehyde level and final serum malondialdehyde level), White blood cell count (initial differential white blood cell count and final differential white blood cell count), c-reactive protein measurements (initial c-reactive protein serum level and final c-reactive protein serum level) as well as volatile organic compound (VOC) sampling (initial VOC, VOC 5min, VOC 15min, VOC 30min, VOC 45min and final VOC). Receives: Diagnostic Test: Initial serum malondialdehyde level; Diagnostic Test: Final serum malondialdehyde level; Diagnostic Test: Initial differential white blood cell count; Diagnostic Test: Final differential white blood cell count; Diagnostic Test: Initial c-reactive protein serum level; Diagnostic Test: Final c-reactive protein serum level; Diagnostic Test: Initial VOC; Diagnostic Test: VOC 5min; Diagnostic Test: VOC 15min; Diagnostic Test: VOC 30min; Diagnostic Test: VOC 45min; Diagnostic Test: Final VOC |
| LAE group | Active comparator | All patients will undergo measurements of oxydative stress (initial serum malondialdehyde level and final serum malondialdehyde level), White blood cell count (initial differential white blood cell count and final differential white blood cell count), c-reactive protein measurements (initial c-reactive protein serum level and final c-reactive protein serum level) as well as volatile organic compound (VOC) sampling (initial VOC, VOC 5min, VOC 15min, VOC 30min, VOC 45min and final VOC). Receives: Diagnostic Test: Initial serum malondialdehyde level; Diagnostic Test: Final serum malondialdehyde level; Diagnostic Test: Initial differential white blood cell count; Diagnostic Test: Final differential white blood cell count; Diagnostic Test: Initial c-reactive protein serum level; Diagnostic Test: Final c-reactive protein serum level; Diagnostic Test: Initial VOC; Diagnostic Test: VOC 5min; Diagnostic Test: VOC 15min; Diagnostic Test: VOC 30min; Diagnostic Test: VOC 45min; Diagnostic Test: Final VOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Are volatile respiratory gas markers for oxidative stress (such as pentanes, isoprenes) dependent on the surgical method (open versus laparoscopic appendectomy)?
We investigate the respiratory volatile organic compounds before, during and at the end of surgery and compare the respiratory gas profiles of the two groups open versus laparoscopic appendectomy.
Measured: 1 year
Secondary outcomes (2)
Alterations of serum malondialdehyde serum levels.
The changes of the serum marker for oxidative stress MDH before and after surgery will be investigated and the changes in open versus laparoscopic appendectomy will be compared. One sample will be taken preoperatively and one sample postoperatively.
Measured: 1 year
Alterations of inflammation markers.
The changes of the serum inflammation markers before and after surgery will be investigated and the changes in open versus laparoscopic appendectomy will be compared.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start2 Oct 2019
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 40 patients aged 6-18 years suffering from acute appendicitis are to be included. These are divided into 2 groups. Group 1 (n = 20) with laparoscopic and group 2 (n = 20) with open appendectomy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rostock, Graz University of Technology
- Responsible party
- Principal investigator, Warncke Gert, MD, Medical University of Graz
- Investigators
- Holger Till, MD, Study director, Department of Pediatric and Adolescent Surgery, Medical University of GrazGert Warncke, MD, Principal investigator, Department of Pediatric and Adolescent Medicine, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723642
- Sponsor's protocol ID
- 30-120 ex 17/18
- Acronym
- OSAE
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2018
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stringer MD. Acute appendicitis. J Paediatr Child Health. 2017 Nov;53(11):1071-1076. doi: 10.1111/jpc.13737. Epub 2017 Oct 17.
PubMed 29044790Ohmann C, Franke C, Kraemer M, Yang Q. [Status report on epidemiology of acute appendicitis]. Chirurg. 2002 Aug;73(8):769-76. doi: 10.1007/s00104-002-0512-7. German.
PubMed 12425152Gorter RR, Eker HH, Gorter-Stam MA, Abis GS, Acharya A, Ankersmit M, Antoniou SA, Arolfo S, Babic B, Boni L, Bruntink M, van Dam DA, Defoort B, Deijen CL, DeLacy FB, Go PM, Harmsen AM, van den Helder RS, Iordache F, Ket JC, Muysoms FE, Ozmen MM, Papoulas M, Rhodes M, Straatman J, Tenhagen M, Turrado V, Vereczkei A, Vilallonga R, Deelder JD, Bonjer J. Diagnosis and management of acute appendicitis. EAES consensus development conference 2015. Surg Endosc. 2016 Nov;30(11):4668-4690. doi: 10.1007/s00464-016-5245-7. Epub 2016 Sep 22.
PubMed 27660247Binnebosel M, Otto J, Stumpf M, Mahnken AH, Gassler N, Schumpelick V, Truong S. [Acute appendicitis. Modern diagnostics--surgical ultrasound]. Chirurg. 2009 Jul;80(7):579-87. doi: 10.1007/s00104-009-1684-1. German.
PubMed 19471900Kim M, Kim SJ, Cho HJ. International normalized ratio and serum C-reactive protein are feasible markers to predict complicated appendicitis. World J Emerg Surg. 2016 Jun 21;11:31. doi: 10.1186/s13017-016-0081-6. eCollection 2016.
PubMed 27330547Svensson JF, Hall NJ, Eaton S, Pierro A, Wester T. A review of conservative treatment of acute appendicitis. Eur J Pediatr Surg. 2012 Jun;22(3):185-94. doi: 10.1055/s-0032-1320014. Epub 2012 Jul 5.
PubMed 22767171Blakely ML, Williams R, Dassinger MS, Eubanks JW 3rd, Fischer P, Huang EY, Paton E, Culbreath B, Hester A, Streck C, Hixson SD, Langham MR Jr. Early vs interval appendectomy for children with perforated appendicitis. Arch Surg. 2011 Jun;146(6):660-5. doi: 10.1001/archsurg.2011.6. Epub 2011 Feb 21.
PubMed 21339413Whyte C, Levin T, Harris BH. Early decisions in perforated appendicitis in children: lessons from a study of nonoperative management. J Pediatr Surg. 2008 Aug;43(8):1459-63. doi: 10.1016/j.jpedsurg.2007.11.032.
PubMed 18675635Li X, Zhang J, Sang L, Zhang W, Chu Z, Li X, Liu Y. Laparoscopic versus conventional appendectomy--a meta-analysis of randomized controlled trials. BMC Gastroenterol. 2010 Nov 3;10:129. doi: 10.1186/1471-230X-10-129.
PubMed 21047410Coccolini F, Trana C, Sartelli M, Catena F, Di Saverio S, Manfredi R, Montori G, Ceresoli M, Falcone C, Ansaloni L. Laparoscopic management of intra-abdominal infections: Systematic review of the literature. World J Gastrointest Surg. 2015 Aug 27;7(8):160-9. doi: 10.4240/wjgs.v7.i8.160.
PubMed 26328036Ciftci F. Laparoscopic vs mini-incision open appendectomy. World J Gastrointest Surg. 2015 Oct 27;7(10):267-72. doi: 10.4240/wjgs.v7.i10.267.
PubMed 26525039Noviello C, Romano M, Martino A, Cobellis G. Transumbilical Laparoscopic-Assisted Appendectomy in the Treatment of Acute Uncomplicated Appendicitis in Children. Gastroenterol Res Pract. 2015;2015:949162. doi: 10.1155/2015/949162. Epub 2015 Sep 29.
PubMed 26491433Khan SY, Al-Balushi ZN, Bhatti KM, Ehsan T, Mandhan P. Cost Comparison between Laparoscopic and Open Appendectomies in Children. Sultan Qaboos Univ Med J. 2013 May;13(2):275-9. doi: 10.12816/0003234. Epub 2013 May 9.
PubMed 23862034Zelzer S, Oberreither R, Bernecker C, Stelzer I, Truschnig-Wilders M, Fauler G. Measurement of total and free malondialdehyde by gas-chromatography mass spectrometry--comparison with high-performance liquid chromatography methology. Free Radic Res. 2013 Aug;47(8):651-6. doi: 10.3109/10715762.2013.812205. Epub 2013 Jul 2.
PubMed 23745592McCrum-Gardner E. Which is the correct statistical test to use? Br J Oral Maxillofac Surg. 2008 Jan;46(1):38-41. doi: 10.1016/j.bjoms.2007.09.002. Epub 2007 Oct 24.
PubMed 17961892
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Oxidative Stress - Open Appendectomy (OAE) Versus Laparoscopic Appendectomy (LAE) in Childhood and Adolescence - A Pilot Study
- ClinicalTrials.gov ID
- NCT03723642
- Acronym / sponsor ID
- OSAE / 30-120 ex 17/18
- Conditions
- Appendicitis Acute
- Keywords
- acute appendicitis, volatile organic compounds, oxidative stress, laparoscopic appendectomy, open appendectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- University of Rostock, Graz University of Technology
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the planned prospective randomized study, oxidative stress will be investigated by analyzing volatile organic compounds in the exhaled air in children. Children who have undergone open versus laparoscopic surgery for appendicitis will be compared. A better understanding of the effects of the surgical technique could be a prerequisite for an optimized surgical setting. It could also lead to recommendations for pre- or perioperatively antioxidative agents.
Detailed description
Aim of the study: In the planned prospective randomized study, oxidative stress will be investigated by analyzing VOCs (volatile organic compounds) in the exhaled breath in children undergoing open or laparoscopic surgery for appendicitis at the Department of Pediatric and Adolescent Surgery of the Medical University of Graz. A resulting better understanding of the effects of the surgical technique can a) be a pre-condition for an optimized surgical setting and b) possibly lead to recommendations of pre- or perioperatively antioxidatively active substances and c) be a base for future surgical procedures.
Study design: This is a prospective randomized pilot study in children and adolescents undergoing surgery due to acute appendicitis. Patients with complicated appendicitis and those with an intraoperatively caused disorder will be excluded. The operation within the context of this study is exclusively conducted by specialists of the Department of Pediatric and Adolescent Surgery of the Medical University of Graz, who perform both - open and laparoscopic surgical techniques. 40 patients aged 6-18 years suffering from acute appendicitis are to be included. These are divided into 2 groups. Group 1 (n = 20) with laparoscopic and group 2 (n = 20) with open appendectomy.
Recruitment and compensation of study participants: Parents/patients are made aware of the study by means of an information sheet and are provided with a declaration of consent if interested. Participants do not receive any compensation for participating in the study.
Sampling of exhaled VOCs (volatile organic compounds) using NTME (needle trap microextraction) for measurement OS (oxidative stress): Number of samples: 2 samples each from exhaled breath at the times defined below (in total n = 12). The time of sampling: t1 before anaesthetic introduction (n = 2); t2 after anesthetic introduction (n = 2); t3 15 minutes after cut (n = 2); t4 30 minutes after cut (n = 2); t5 45 minutes after cut (n = 2); t6 after seam (n = 2).
Analysis of exhaled VOCs for measurement OS: The exhaled breath samples taken are placed in an injector of a gas chromatograph into the inert carrier gas stream (He). The substances are assigned according to their retention time in the chromatogram and its mass spectrum. Unknown connections in the mass spectrum of exhaled breath is used as a basis for comparison with a reference database.
Sampling of blood markers for measurement OS: a) sampling times for WBCs, CRP: t1 = 1 sample preoperatively (before anaesthetic introduction) and t2 = 1 sample after 24 h. b) sampling times for malondialdehyde: t1 = 1 sample before anaesthetic introduction and t2 = 1 sample after suture.
Histopathological grading: The explanted vermiform appendix becomes the histopathological Refurbishment at the Institute of Pathology of the Medical University of Graz. There the classification is made according to the histopathological findings in 4 degrees of severity (acute focal appendicitis, acute suppurative appendicitis, acut gangrenous appendicitis, perforated appendicitis).
Sampling WBCs, CRP: These are carried out within the scope of routine diagnostics due to the clinical presentation of the AA (acute appendicitis).
Sampling VOCs: 2 breath samples are taken from each patient during expiration, taken from it. To collect the samples, the investigators use an automatic Sampling device connected directly to a capnometer. This system works with microextraction (NTME) and enables a automatic sampling of the alveolar air, i.e. in the plateau of the CO2 curve. The samples are sent to the Intitute of Rostock Medical Breath Analysis and Technologies (RoMBAT) as cooperation partner. This partner was selected because it already has extensive experience with the methodology and studies on oxidative stress during operations.
Malondialdehyde (MDA) sampling: Malondialdehyde is analysed at the Clinical Institute for Medical and Chemical Laboratory Diagnostics at the Medical University of Graz means of ultra-modern GC-MS method. For this purpose, the patient is assigned to the two Measuring times 2 x 400 μl EDTA plasma taken. The second sample serves only as a safety measure if repeat measurements are necessary. The samples obtained must be deep-frozen at -80 °C within 2 hours. . Subsequently (at the latest on the following day) the samples must be analyzed to the Institute.
Planned evaluation: The statistical investigations are carried out with SPSS 23.0®. Graphical representation of the data is performed with GraphPad Prism 7®. To investigate whether the main target variables (VOCs) differ in the course between the two groups, linear models are used for repeated measurements with group (open versus laparoscopic appendectomy) as intermediate subject factor and time of measurement (t1 to t6) as internal subject factor. In the case of deviations from the normal distribution, transformations are taken into consideration. The secondary targets, i.e. the changes in the serum markers on theTimes t1 and t6, are compared between the 2 groups (open versus laparoscopic appendectomy) by Mann-Whitney U-test (data not normally distributed) or independent T-test (with normal distribution). In order to establish relationships between the VOCs and the serum markers for oxidative stress at times t1 and t6 a correlation analysis is performed (depending on the data, Pearson or Spearman Rho). All statistical tests are carried out on two sides and all p-values are interpreted purely exploratively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 40 patients aged 6-18 years suffering from acute appendicitis are to be included. These are divided into 2 groups. Group 1 (n = 20) with laparoscopic and group 2 (n = 20) with open appendectomy.
| Arm | Type | Receives |
|---|---|---|
| OAE group | Active comparator | Diagnostic Test: Initial serum malondialdehyde level, Diagnostic Test: Final serum malondialdehyde level, Diagnostic Test: Initial differential white blood cell count, Diagnostic Test: Final differential white blood cell count, Diagnostic Test: Initial c-reactive protein serum level, Diagnostic Test: Final c-reactive protein serum level, Diagnostic Test: Initial VOC, Diagnostic Test: VOC 5min, Diagnostic Test: VOC 15min, Diagnostic Test: VOC 30min, Diagnostic Test: VOC 45min, Diagnostic Test: Final VOCAll patients will undergo measurements of oxydative stress (initial serum malondialdehyde level and final serum malondialdehyde level), White blood cell count (initial differential white blood cell count and final differential white blood cell count), c-reactive protein measurements (initial c-reactive protein serum level and final c-reactive protein serum level) as well as volatile organic compound (VOC) sampling (initial VOC, VOC 5min, VOC 15min, VOC 30min, VOC 45min and final VOC). |
| LAE group | Active comparator | Diagnostic Test: Initial serum malondialdehyde level, Diagnostic Test: Final serum malondialdehyde level, Diagnostic Test: Initial differential white blood cell count, Diagnostic Test: Final differential white blood cell count, Diagnostic Test: Initial c-reactive protein serum level, Diagnostic Test: Final c-reactive protein serum level, Diagnostic Test: Initial VOC, Diagnostic Test: VOC 5min, Diagnostic Test: VOC 15min, Diagnostic Test: VOC 30min, Diagnostic Test: VOC 45min, Diagnostic Test: Final VOCAll patients will undergo measurements of oxydative stress (initial serum malondialdehyde level and final serum malondialdehyde level), White blood cell count (initial differential white blood cell count and final differential white blood cell count), c-reactive protein measurements (initial c-reactive protein serum level and final c-reactive protein serum level) as well as volatile organic compound (VOC) sampling (initial VOC, VOC 5min, VOC 15min, VOC 30min, VOC 45min and final VOC). |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age from 6-18 years
- reliable diagnosis of acute appendicitis
- surgical therapy using open/laparoscopic surgical technique
- given approval
Key exclusion criteria (8 listed)
- Age not between 6 and 18 years
- chronic underlying disease/autoimmune disease
- complicated appendicitis (perforation, consecutive purulent peritonitis, abscess formation)
- infection outside acute appendicitis
- SIRS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial serum malondialdehyde levelBlood sample (0.4ml) will be obtained within 5 minutes before induction of general anaesthesia. Samples will be obtained in both groups (LAE and OAE) | Diagnostic test | LAE group, OAE group |
| Final serum malondialdehyde levelBlood sample (0.4ml) will be obtained within 5 minutes after wound closure. Samples will be obtained in both groups (LAE and OAE) | Diagnostic test | LAE group, OAE group |
| Initial differential white blood cell countDifferential blood counts (microscopic) will be obtained during pre-operative routine work-up. Samples will be obtained in both groups (LAE and OAE). | Diagnostic test | LAE group, OAE group |
| Final differential white blood cell countDifferential blood counts (microscopic) will be obtained 24h after the first sample (Initial differential blood count). Samples will be obtained in both groups (LAE and OAE). | Diagnostic test | LAE group, OAE group |
| Initial c-reactive protein serum levelC-reactive protein levels will be obtained during pre-operative routine work-up. Samples will be obtained in both groups (LAE and OAE). | Diagnostic test | LAE group, OAE group |
| Final c-reactive protein serum levelC-reactive protein levels will be obtained 24h after the first sample (initial c-reactive protein level). Samples will be obtained in both groups (LAE and OAE). | Diagnostic test | LAE group, OAE group |
| Initial VOCVolatile organic compound sampling (2 samples within 5 minutes) within 10 minutes before induction of general anesthesia | Diagnostic test | LAE group, OAE group |
| VOC 5minVolatile organic compound sampling (2 samples within5 minutes) within 5 minutes after endotracheal intubation before skin incision. | Diagnostic test | LAE group, OAE group |
| VOC 15minVolatile organic compound sampling (2 samples within 5 minutes) 15 minutes after skin incision. | Diagnostic test | LAE group, OAE group |
| VOC 30minVolatile organic compound sampling (2 samples within 5 minutes) 30 minutes after skin incision. | Diagnostic test | LAE group, OAE group |
| VOC 45minVolatile organic compound sampling (2 samples within 5 minutes) 45 minutes after skin incision. | Diagnostic test | LAE group, OAE group |
| Final VOCVolatile organic compound sampling (2 samples within 5 minutes) within 5 minutes after skin closure. | Diagnostic test | LAE group, OAE group |
Primary outcome
Are volatile respiratory gas markers for oxidative stress (such as pentanes, isoprenes) dependent on the surgical method (open versus laparoscopic appendectomy)?
Time frame: 1 year
We investigate the respiratory volatile organic compounds before, during and at the end of surgery and compare the respiratory gas profiles of the two groups open versus laparoscopic appendectomy.
2 secondary outcomes
Alterations of serum malondialdehyde serum levels.
Time frame: 1 year
Alterations of inflammation markers.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Background: PubMed 29044790Stringer MD. Acute appendicitis. J Paediatr Child Health. 2017 Nov;53(11):1071-1076. doi: 10.1111/jpc.13737. Epub 2017 Oct 17.
- Background: PubMed 12425152Ohmann C, Franke C, Kraemer M, Yang Q. [Status report on epidemiology of acute appendicitis]. Chirurg. 2002 Aug;73(8):769-76. doi: 10.1007/s00104-002-0512-7. German.
- Background: PubMed 27660247Gorter RR, Eker HH, Gorter-Stam MA, Abis GS, Acharya A, Ankersmit M, Antoniou SA, Arolfo S, Babic B, Boni L, Bruntink M, van Dam DA, Defoort B, Deijen CL, DeLacy FB, Go PM, Harmsen AM, van den Helder RS, Iordache F, Ket JC, Muysoms FE, Ozmen MM, Papoulas M, Rhodes M, Straatman J, Tenhagen M, Turrado V, Vereczkei A, Vilallonga R, Deelder JD, Bonjer J. Diagnosis and management of acute appendicitis. EAES consensus development conference 2015. Surg Endosc. 2016 Nov;30(11):4668-4690. doi: 10.1007/s00464-016-5245-7. Epub 2016 Sep 22.
- Background: PubMed 19471900Binnebosel M, Otto J, Stumpf M, Mahnken AH, Gassler N, Schumpelick V, Truong S. [Acute appendicitis. Modern diagnostics--surgical ultrasound]. Chirurg. 2009 Jul;80(7):579-87. doi: 10.1007/s00104-009-1684-1. German.
- Background: PubMed 27330547Kim M, Kim SJ, Cho HJ. International normalized ratio and serum C-reactive protein are feasible markers to predict complicated appendicitis. World J Emerg Surg. 2016 Jun 21;11:31. doi: 10.1186/s13017-016-0081-6. eCollection 2016.
- Background: PubMed 22767171Svensson JF, Hall NJ, Eaton S, Pierro A, Wester T. A review of conservative treatment of acute appendicitis. Eur J Pediatr Surg. 2012 Jun;22(3):185-94. doi: 10.1055/s-0032-1320014. Epub 2012 Jul 5.
- Background: PubMed 21339413Blakely ML, Williams R, Dassinger MS, Eubanks JW 3rd, Fischer P, Huang EY, Paton E, Culbreath B, Hester A, Streck C, Hixson SD, Langham MR Jr. Early vs interval appendectomy for children with perforated appendicitis. Arch Surg. 2011 Jun;146(6):660-5. doi: 10.1001/archsurg.2011.6. Epub 2011 Feb 21.
- Background: PubMed 18675635Whyte C, Levin T, Harris BH. Early decisions in perforated appendicitis in children: lessons from a study of nonoperative management. J Pediatr Surg. 2008 Aug;43(8):1459-63. doi: 10.1016/j.jpedsurg.2007.11.032.
- Background: PubMed 21047410Li X, Zhang J, Sang L, Zhang W, Chu Z, Li X, Liu Y. Laparoscopic versus conventional appendectomy--a meta-analysis of randomized controlled trials. BMC Gastroenterol. 2010 Nov 3;10:129. doi: 10.1186/1471-230X-10-129.
- Background: PubMed 26328036Coccolini F, Trana C, Sartelli M, Catena F, Di Saverio S, Manfredi R, Montori G, Ceresoli M, Falcone C, Ansaloni L. Laparoscopic management of intra-abdominal infections: Systematic review of the literature. World J Gastrointest Surg. 2015 Aug 27;7(8):160-9. doi: 10.4240/wjgs.v7.i8.160.
- Background: PubMed 26525039Ciftci F. Laparoscopic vs mini-incision open appendectomy. World J Gastrointest Surg. 2015 Oct 27;7(10):267-72. doi: 10.4240/wjgs.v7.i10.267.
- Background: PubMed 26491433Noviello C, Romano M, Martino A, Cobellis G. Transumbilical Laparoscopic-Assisted Appendectomy in the Treatment of Acute Uncomplicated Appendicitis in Children. Gastroenterol Res Pract. 2015;2015:949162. doi: 10.1155/2015/949162. Epub 2015 Sep 29.
- Individual participant dataSharing planned: No
Related trials for Appendicitis Acute
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruitingPhase 2
Patient Choice Between Antibiotics and Appendectomy in Uncomplicated Appendicitis (FRENCH 47 - ALACARTE)
Acute Appendicitis
Active, not recruitingObservational study
Retrospective Acute Care Appendectomy Study
Acute Appendicitis
Not yet recruiting
Immediate Laparoscopic Appendectomy Versus Interval Laparoscopic Appendectomy for Early Appendicular Mass
Appendicular Mass, Acute Appendicitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holger Till, MD study director
Department of Pediatric and Adolescent Surgery, Medical University of Graz
Gert Warncke, MD principal investigator
Department of Pediatric and Adolescent Medicine, Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial serum malondialdehyde level, Final serum malondialdehyde level and Initial differential white blood cell count in people with Appendicitis Acute, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gert Warncke, MD (01143316385 ext. 81153, gert.warncke@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Are volatile respiratory gas markers for oxidative stress (such as pentanes, isoprenes) dependent on the surgical method (open versus laparoscopic appendectomy)? (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03723642, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.