Appendicitis AcutePENDI_CSINCT04464382
Evaluating the Safety and Efficacy of a Outpatient Appendectomy
A study testing Outpatient (OA) and Hospitalization appendectomy (HA) in people with Appendicitis Acute and Appendectomy, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
This study evaluates the Safety and Efficacy of a outpatient appendectomy. Half of participants will be perform the hospitalization, while the other half will undergo the outpatient appendectomy Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Appendicitis Acute, Appendectomy
- What is being tested?
- Outpatient (OA) and Hospitalization appendectomy (HA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 1 siteSpain
- Study dates
- 28 Apr 2019to 28 Oct 2021
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over 14 years of age and who provide informed consent to participate in the study.
- Patients with non complicated acute appendicitis requiring and urgent appendectomy (laparoscopic or minimum incision)
- Negative appendicectomy.
Who cannot join
- Complicated acute appendicitis (abscess, perforated, necrosis and peritonitis)
- Need to place intraoperative drainage.
- Patients with American Society of Anesthesiologists (ASA) >IV.
- Immunosuppressed patients.
- Pregnant.
- Possibility of inflammatory bowel disease.
Show all 9Show fewer
- No family support.
- No informed consent signature.
- Impossibility to comply with the established follow-up
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Virgen Del Rocio
Seville, 41013
Pareja C Felipe, PhD, +34630962443, felipe.pareja67@gmail.com
Durán MC Virginia, MD, +34620073024, virginia.dm.87@gmail.com
About this study
Official title: A Randomized Double-blind Clinical Trial to Evaluate the Safety and Efficacy of a Outpatient Appendectomy (PENDI_CSI)
This study evaluates the Safety and Efficacy of a outpatient appendectomy. Half of participants will be perform the hospitalization, while the other half will undergo the outpatient appendectomy
Read the detailed description
Acute appendicitis (AA) is one of the most common causes of acute abdomen and one of the most frequent diagnoses that require urgent surgery worldwide.
Many laparoscopic procedures are currently performed on an outpatient basis.Laparoscopic appendectomy, however, continues to require postoperative hospitalization averaging between 1 and 2 days, at most institutions.
At present ambulatory laparoscopic appendectomy (LA) are gained popularity due to the improved understanding of patient selection criteria, the application of enhanced recovery pathways, and the potential for improving healthcare resource utilization.
There are few studies about to compare the morbidity and readmission rates between ambulatory and conventional LA.
There is a lack of high-quality comparative studies making conclusive recommendations not possible at this time. Based on current data, ambulatory LA may be safe and feasible as compared with conventional LA.
- Conditions
- Appendicitis Acute, Appendectomy
- Being tested
- Outpatient (OA), Hospitalization appendectomy (HA)
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient (OA)Procedure or surgery
Patients who are candidates for OA and therefore pre-selected based on the primary data and characteristics of the clinical signs, will be admitted to the surgical observation in charge of our service. The patient will be informed in detail of the intervention to be performed and discharge on an outpatient basis and will sign the informed consent understanding and thus accepting all the information. The patient will undergo surgery using a laparoscopic or open technique with minimal incision.
Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. In this case, we will perform the blind randomization of the patients. If all the inclusion requirements for the study are met, and the patient belongs to the OA group (case group), he will be discharged on an outpatient basis from the post-surgical stay unit without requiring hospital admission.
Hospitalization appendectomy (HA)Procedure or surgery
Patients who are candidates for HA and therefore pre-selected based on the primary data and characteristics of the clinical signs, will be admitted to the surgical observation in charge of our service. The patient will be informed in detail of the intervention to be performed and discharge on an outpatient basis and will sign the informed consent understanding and thus accepting all the information. The patient will undergo surgery using a laparoscopic or open technique with minimal incision.
Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. In this case, we will perform the blind randomization of the patients. If all the inclusion requirements for the study are met, and the patient belongs to the case group (HA), he will be admitted in hospital beds.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient appendectomy | Experimental | Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed.
Patients after surgery will go to the anesthetic recovery room without requiring hospital admission. The degree of satisfaction of the quality of the service and the care that must be completed before discharge and after surgery will be recorded.
1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure. Receives: Procedure: Outpatient (OA) |
| Hospitalization appendectomy | Active comparator | Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed.
Patients after surgery will go to the anesthetic recovery room and then be admitted to hospital beds, to be discharged within approximately 12 hours.
1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure. Receives: Procedure: Hospitalization appendectomy (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of ambulatory appendectomy patients that have ambulatory surgery
Analyze morbidity of appendectomy patients to determine the safety of ambulatory surgery
Measured: 20 months
Rates of readmission of appendectomy patients that had ambulatory surgery
Analyze rates of readmission of appendectomy patients to determine the safety of ambulatory surgery
Measured: 20 months
Secondary outcomes (4)
Prevalence of ambulatory appendectomy patients
Measure the percentage of ambulatory surgery and uncomplicated acute appendicitis vs the percentage of ambulatory surgery in failure patients with the same pathology e.g.
- Uncontrolled abdominal pain with analgesia.
- Upper airway discomfort related to intubation that is not controlled with medication.
- Pain in the back or shoulders in relation to the pneumoperitoneum that are in patients with not controlled with the medication.
- Hemodynamically abnormal. Uncontrolled bleeding at the level of any of the wounds. Need for reoperation. Need to re-enter or consult the Emergency Service No spontaneous urination.
- Nausea / vomiting.
- Oral intolerance.
- No wandering.
- Insecurity or fear of the patient at discharge.
Measured: 20 months
Media of time until the total incorporation to the activities of the daily life after appendectomy
To value the time until the total incorporation to the activities of the daily life after appendectomy.
Measured: 20 months
Rates of satisfaction
Measure the degree of satisfaction of our patients with outpatient management after appendectomy, using a satisfaction questionnaire.
Measured: 20 months
Costs of the outpatient regimen versus the hospitalization of patients
Compare the costs of the outpatient regimen versus the hospitalization of patients with uncomplicated acute appendicitis (cost-minimization analysis).
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start28 Apr 2019
- Primary completion28 Apr 2021 (estimated)
- Study completion28 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 291 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pareja C Felipe, PhD, Principal investigator, Hospitales Universitarios Virgen del RocíoPadillo R Javier, PhD, Study director, Hospitales Universitarios Virgen del RocíoDurán MC Virginia María, MD, Study chair, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464382
- Sponsor's protocol ID
- PENDI_CSI
- Acronym
- PENDI_CSI
- Status last verified
- Jul 2020
- First submitted
- 11 Feb 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, Sugrue M, De Moya M, Gomes CA, Bhangu A, Agresta F, Moore EE, Soreide K, Griffiths E, De Castro S, Kashuk J, Kluger Y, Leppaniemi A, Ansaloni L, Andersson M, Coccolini F, Coimbra R, Gurusamy KS, Campanile FC, Biffl W, Chiara O, Moore F, Peitzman AB, Fraga GP, Costa D, Maier RV, Rizoli S, Balogh ZJ, Bendinelli C, Cirocchi R, Tonini V, Piccinini A, Tugnoli G, Jovine E, Persiani R, Biondi A, Scalea T, Stahel P, Ivatury R, Velmahos G, Andersson R. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016 Jul 18;11:34. doi: 10.1186/s13017-016-0090-5. eCollection 2016.
PubMed 27437029Cash CL, Frazee RC, Abernathy SW, Childs EW, Davis ML, Hendricks JC, Smith RW. A prospective treatment protocol for outpatient laparoscopic appendectomy for acute appendicitis. J Am Coll Surg. 2012 Jul;215(1):101-5; discussion 105-6. doi: 10.1016/j.jamcollsurg.2012.02.024. Epub 2012 May 19.
PubMed 22609030Aguayo P, Alemayehu H, Desai AA, Fraser JD, St Peter SD. Initial experience with same day discharge after laparoscopic appendectomy for nonperforated appendicitis. J Surg Res. 2014 Jul;190(1):93-7. doi: 10.1016/j.jss.2014.03.012. Epub 2014 Mar 12.
PubMed 24725679Frazee RC, Abernathy SW, Isbell CL, Isbell T, Regner JL, Smith RD. Outpatient Laparoscopic Appendectomy: Is It Time to End the Discussion? J Am Coll Surg. 2016 Apr;222(4):473-7. doi: 10.1016/j.jamcollsurg.2015.12.053. Epub 2016 Jan 14.
PubMed 26920990Frazee R, Burlew CC, Regner J, McIntyre R, Peltz E, Cribari C, Dunn J, Butler L, Reckard P, Dissanaike S, Karimi K, Behnfield C, Melo N, Margulies D. Discussion of: "Outpatient laparoscopic appendectomy can be successfully performed for uncomplicated appendicitis: A Southwestern Surgical Congress multicenter trial". Am J Surg. 2017 Dec;214(6):1010-1011. doi: 10.1016/j.amjsurg.2017.10.003. Epub 2017 Oct 5. No abstract available.
PubMed 29079020Trejo-Avila M, Cardenas-Lailson E, Valenzuela-Salazar C, Herrera-Esquivel J, Moreno-Portillo M. Ambulatory versus conventional laparoscopic appendectomy: a systematic review and meta-analysis. Int J Colorectal Dis. 2019 Aug;34(8):1359-1368. doi: 10.1007/s00384-019-03341-y. Epub 2019 Jul 5.
PubMed 31273450
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Clinical Trial to Evaluate the Safety and Efficacy of a Outpatient Appendectomy (PENDI_CSI)
- ClinicalTrials.gov ID
- NCT04464382
- Acronym / sponsor ID
- PENDI_CSI / PENDI_CSI
- Conditions
- Appendicitis Acute, Appendectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 291 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 28 Apr 2019 (actual)
- Primary completion
- 28 Apr 2021 (estimated)
- Study completion
- 28 Oct 2021 (estimated)
- First posted
- 9 Jul 2020 (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.
This study evaluates the Safety and Efficacy of a outpatient appendectomy. Half of participants will be perform the hospitalization, while the other half will undergo the outpatient appendectomy
Detailed description
Acute appendicitis (AA) is one of the most common causes of acute abdomen and one of the most frequent diagnoses that require urgent surgery worldwide.
Many laparoscopic procedures are currently performed on an outpatient basis.Laparoscopic appendectomy, however, continues to require postoperative hospitalization averaging between 1 and 2 days, at most institutions.
At present ambulatory laparoscopic appendectomy (LA) are gained popularity due to the improved understanding of patient selection criteria, the application of enhanced recovery pathways, and the potential for improving healthcare resource utilization.
There are few studies about to compare the morbidity and readmission rates between ambulatory and conventional LA.
There is a lack of high-quality comparative studies making conclusive recommendations not possible at this time. Based on current data, ambulatory LA may be safe and feasible as compared with conventional LA.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient appendectomy | Experimental | Procedure: Outpatient (OA)Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. Patients after surgery will go to the anesthetic recovery room without requiring hospital admission. The degree of satisfaction of the quality of the service and the care that must be completed before discharge and after surgery will be recorded. 1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure. |
| Hospitalization appendectomy | Active comparator | Procedure: Hospitalization appendectomy (HA)Patients with acute uncomplicated appendicitis that require emergency appendectomy. The intervention will be the classic.Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. Patients after surgery will go to the anesthetic recovery room and then be admitted to hospital beds, to be discharged within approximately 12 hours. 1 phone review call will be made per month +/- 30 days in order to assess the safety and satisfaction of the procedure. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 14 years of age and who provide informed consent to participate in the study.
- Patients with non complicated acute appendicitis requiring and urgent appendectomy (laparoscopic or minimum incision)
- Negative appendicectomy.
Key exclusion criteria (9 listed)
- Complicated acute appendicitis (abscess, perforated, necrosis and peritonitis)
- Need to place intraoperative drainage.
- Patients with American Society of Anesthesiologists (ASA) >IV.
- Immunosuppressed patients.
- Pregnant.
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 |
|---|---|---|
| Outpatient (OA)Patients who are candidates for OA and therefore pre-selected based on the primary data and characteristics of the clinical signs, will be admitted to the surgical observation in charge of our service. The patient will be informed in detail of the intervention to be performed and discharge on an outpatient basis and will sign the informed consent understanding and thus accepting all the information. The patient will undergo surgery using a laparoscopic or open technique with minimal incision. Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. In this case, we will perform the blind randomization of the patients. If all the inclusion requirements for the study are met, and the patient belongs to the OA group (case group), he will be discharged on an outpatient basis from the post-surgical stay unit without requiring hospital admission. | Procedure or surgery | Outpatient appendectomy |
| Hospitalization appendectomy (HA)Patients who are candidates for HA and therefore pre-selected based on the primary data and characteristics of the clinical signs, will be admitted to the surgical observation in charge of our service. The patient will be informed in detail of the intervention to be performed and discharge on an outpatient basis and will sign the informed consent understanding and thus accepting all the information. The patient will undergo surgery using a laparoscopic or open technique with minimal incision. Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. In this case, we will perform the blind randomization of the patients. If all the inclusion requirements for the study are met, and the patient belongs to the case group (HA), he will be admitted in hospital beds. | Procedure or surgery | Hospitalization appendectomy |
Primary outcome
Rates of ambulatory appendectomy patients that have ambulatory surgery
Time frame: 20 months
Analyze morbidity of appendectomy patients to determine the safety of ambulatory surgery
Rates of readmission of appendectomy patients that had ambulatory surgery
Time frame: 20 months
Analyze rates of readmission of appendectomy patients to determine the safety of ambulatory surgery
4 secondary outcomes
Prevalence of ambulatory appendectomy patients
Time frame: 20 months
Media of time until the total incorporation to the activities of the daily life after appendectomy
Time frame: 20 months
Rates of satisfaction
Time frame: 20 months
Costs of the outpatient regimen versus the hospitalization of patients
Time frame: 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 27437029Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, Sugrue M, De Moya M, Gomes CA, Bhangu A, Agresta F, Moore EE, Soreide K, Griffiths E, De Castro S, Kashuk J, Kluger Y, Leppaniemi A, Ansaloni L, Andersson M, Coccolini F, Coimbra R, Gurusamy KS, Campanile FC, Biffl W, Chiara O, Moore F, Peitzman AB, Fraga GP, Costa D, Maier RV, Rizoli S, Balogh ZJ, Bendinelli C, Cirocchi R, Tonini V, Piccinini A, Tugnoli G, Jovine E, Persiani R, Biondi A, Scalea T, Stahel P, Ivatury R, Velmahos G, Andersson R. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg. 2016 Jul 18;11:34. doi: 10.1186/s13017-016-0090-5. eCollection 2016.
- Background: PubMed 22609030Cash CL, Frazee RC, Abernathy SW, Childs EW, Davis ML, Hendricks JC, Smith RW. A prospective treatment protocol for outpatient laparoscopic appendectomy for acute appendicitis. J Am Coll Surg. 2012 Jul;215(1):101-5; discussion 105-6. doi: 10.1016/j.jamcollsurg.2012.02.024. Epub 2012 May 19.
- Background: PubMed 24725679Aguayo P, Alemayehu H, Desai AA, Fraser JD, St Peter SD. Initial experience with same day discharge after laparoscopic appendectomy for nonperforated appendicitis. J Surg Res. 2014 Jul;190(1):93-7. doi: 10.1016/j.jss.2014.03.012. Epub 2014 Mar 12.
- Background: PubMed 26920990Frazee RC, Abernathy SW, Isbell CL, Isbell T, Regner JL, Smith RD. Outpatient Laparoscopic Appendectomy: Is It Time to End the Discussion? J Am Coll Surg. 2016 Apr;222(4):473-7. doi: 10.1016/j.jamcollsurg.2015.12.053. Epub 2016 Jan 14.
- Background: PubMed 29079020Frazee R, Burlew CC, Regner J, McIntyre R, Peltz E, Cribari C, Dunn J, Butler L, Reckard P, Dissanaike S, Karimi K, Behnfield C, Melo N, Margulies D. Discussion of: "Outpatient laparoscopic appendectomy can be successfully performed for uncomplicated appendicitis: A Southwestern Surgical Congress multicenter trial". Am J Surg. 2017 Dec;214(6):1010-1011. doi: 10.1016/j.amjsurg.2017.10.003. Epub 2017 Oct 5. No abstract available.
- Background: PubMed 31273450Trejo-Avila M, Cardenas-Lailson E, Valenzuela-Salazar C, Herrera-Esquivel J, Moreno-Portillo M. Ambulatory versus conventional laparoscopic appendectomy: a systematic review and meta-analysis. Int J Colorectal Dis. 2019 Aug;34(8):1359-1368. doi: 10.1007/s00384-019-03341-y. Epub 2019 Jul 5.
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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.
Pareja C Felipe, PhD principal investigator
Hospitales Universitarios Virgen del Rocío
Padillo R Javier, PhD study director
Hospitales Universitarios Virgen del Rocío
Durán MC Virginia María, MD study chair
Hospitales Universitarios Virgen del Rocío
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient (OA) and Hospitalization appendectomy (HA) in people with Appendicitis Acute and Appendectomy, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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 3 inclusion and 9 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 13 Jan 2021. 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 Spain. 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 Pareja C Felipe, PhD (+34630962443, felipe.pareja67@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of ambulatory appendectomy patients that have ambulatory surgery (time frame: 20 months). The study lists 2 primary outcomes in all. 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 NCT04464382, which also lists 6 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 13 Jan 2021.