Acute AppendicitisNCT01816568
The Comparison of Single Incision Laparoscopic Appendectomy and Three Port Laparoscopic Appendectomy
A study testing SILS appendectomy and Three port laparoscopic appendectomy in people with Acute Appendicitis, run by Maltepe University.
Trial summary
Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. In numerous studies, when conventional laparoscopic appendectomy using 3 ports is compared with open appendectomy, it has advantages of reduced pain, reduced hospital stay, and enhanced cosmetic effects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- SILS appendectomy and Three port laparoscopic appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Feb 2013
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Required laparoscopic cholecystectomy for gallbladder disease.
Who cannot join
- American Society of Anesthesiologists score (ASA) more than III,
- Patients had prior abdominal surgery,
- Pregnancy,
- Ongoing peritoneal dialysis,
- Lack of written informed consent.
About this study
Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. In numerous studies, when conventional laparoscopic appendectomy using 3 ports is compared with open appendectomy, it has advantages of reduced pain, reduced hospital stay, and enhanced cosmetic effects. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study the investigators aimed to compare results of SILS appendectomy and three port conventional laparoscopic appendectomy prospectively.
Read the detailed description
Total of 50 patients who undergoing laparoscopic appendectomy for acute appendicitis will randomly assign to undergo SILS appendectomy group (n = 25) or Three port laparoscopic appendectomy group (n= 25) according to a computer-generated table of random numbers. Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, need for conversion to a standard or three port laparoscopic appendectomy, need for conversion to an open appendectomy will be recorded. Outcome measures include operative morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of colonic leak, wound infection, intrabdominal abscess hospital readmission, and hernia.
- Conditions
- Acute Appendicitis
- Being tested
- SILS appendectomy, Three port laparoscopic appendectomy
- Keywords
- appendicitis, laparoscopy, single incision
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SILS appendectomyProcedure or surgery
Single incision laparoscopic appendectomy will be performed
Three port laparoscopic appendectomyProcedure or surgery
Three port laparoscopic appendectomy will be performed
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | SILS appendectomy Receives: Procedure: SILS appendectomy |
| Group 2 | Active comparator | Three port laparoscopic appendectomy Receives: Procedure: Three port laparoscopic appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Postoperative pain will be assessed according Visual analog scale from 0 (no pain) to 10 (worst pain imaginable. Postoperative six hour VAS (POSH-VAS) and postoperative first day VAS (POFD-VAS) will be recorded and compared.
Measured: Postoperative first 24 hours
Secondary outcomes (3)
Intraoperative complications
Per operative complications will be recorded.
- Bleeding
- Iatrogenic injury
- Bowel perforation
- Complications associated with increased intra-abdominal pressure
Measured: Average of 50 minutes
Operating time
The operating time will be defined as the time from the first incision to the last suture's placement.
Measured: Average of 50 minutes
Postoperative complications
Postoperative complications will be recorded postoperative follow up.
- Bleeding
- Fecal leakage
- Intrabdominal injury
- Wound infection
- Port site hernia
Measured: 24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startFeb 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, manuk norayk manukyan, Maltepe University
- Investigators
- Ugur Deveci, Assoc.Prof., Principal investigator, Maltepe University School of Medicine, General Surgery DepartmentFatih Altintoprak, Assoc.Prof., Principal investigator, Sakarya University School of Medicine, General Surgery DepartmentManuk Norayk Manukyan, Assoc.Prof., Study director, Maltepe University School of Medicine, General Surgery DepartmentSertan Kapakli, Assoc.Prof., Principal investigator, Maltepe University School of Medicine, General Surgery DepartmentAbut Kebudi, Prof., Study chair, Maltepe University School of Medicine, General Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816568
- Sponsor's protocol ID
- mütf4
- Status last verified
- Mar 2013
- First submitted
- 20 Mar 2013
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Single Incision Laparoscopic Appendectomy and Three Port Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT01816568
- Acronym / sponsor ID
- mütf4
- Conditions
- Acute Appendicitis
- Keywords
- appendicitis, laparoscopy, single incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 Mar 2013 (estimated)
- 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.
Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. In numerous studies, when conventional laparoscopic appendectomy using 3 ports is compared with open appendectomy, it has advantages of reduced pain, reduced hospital stay, and enhanced cosmetic effects. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study the investigators aimed to compare results of SILS appendectomy and three port conventional laparoscopic appendectomy prospectively.
Detailed description
Total of 50 patients who undergoing laparoscopic appendectomy for acute appendicitis will randomly assign to undergo SILS appendectomy group (n = 25) or Three port laparoscopic appendectomy group (n= 25) according to a computer-generated table of random numbers. Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, need for conversion to a standard or three port laparoscopic appendectomy, need for conversion to an open appendectomy will be recorded. Outcome measures include operative morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of colonic leak, wound infection, intrabdominal abscess hospital readmission, and hernia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: SILS appendectomySILS appendectomy |
| Group 2 | Active comparator | Procedure: Three port laparoscopic appendectomyThree port laparoscopic appendectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Required laparoscopic cholecystectomy for gallbladder disease.
Key exclusion criteria (5 listed)
- American Society of Anesthesiologists score (ASA) more than III,
- Patients had prior abdominal surgery,
- Pregnancy,
- Ongoing peritoneal dialysis,
- Lack of written informed consent.
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 |
|---|---|---|
| SILS appendectomySingle incision laparoscopic appendectomy will be performed | Procedure or surgery | Group 1 |
| Three port laparoscopic appendectomyThree port laparoscopic appendectomy will be performed | Procedure or surgery | Group 2 |
Primary outcome
Pain score
Time frame: Postoperative first 24 hours
Postoperative pain will be assessed according Visual analog scale from 0 (no pain) to 10 (worst pain imaginable. Postoperative six hour VAS (POSH-VAS) and postoperative first day VAS (POFD-VAS) will be recorded and compared.
3 secondary outcomes
Intraoperative complications
Time frame: Average of 50 minutes
Operating time
Time frame: Average of 50 minutes
Postoperative complications
Time frame: 24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
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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.
Ugur Deveci, Assoc.Prof. principal investigator
Maltepe University School of Medicine, General Surgery Department
Fatih Altintoprak, Assoc.Prof. principal investigator
Sakarya University School of Medicine, General Surgery Department
Manuk Norayk Manukyan, Assoc.Prof. study director
Maltepe University School of Medicine, General Surgery Department
Questions about this trial
What is this clinical trial studying?
A study testing SILS appendectomy and Three port laparoscopic appendectomy in people with Acute Appendicitis, run by Maltepe University.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: Postoperative first 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2013.