The Comparison of Single Incision Laparoscopic Appendectomy and Three Port Laparoscopic Appendectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Comparison of Single Incision Laparoscopic Appendectomy and Three Port Laparoscopic Appendectomy

Conditions
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Acute Appendicitis

Intervention / Treatment
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* Procedure: SILS appendectomy
* Procedure: Three port laparoscopic appendectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Required laparoscopic cholecystectomy for gallbladder disease. Exclusion Criteria: American Society of Anesthesiologists score (ASA) more than III, Patients had prior abdominal surgery, Pregnancy, Ongoing peritoneal dialysis, Lack of written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>SILS appendectomy | Procedure: SILS appendectomy<br>* Single incision laparoscopic appendectomy will be performed<br>|
| Active Comparator: Group 2<br>Three port laparoscopic appendectomy | Procedure: Three port laparoscopic appendectomy<br>* Three port laparoscopic appendectomy will be performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Postoperative first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative complications | Per operative complications will be recorded. Bleeding Iatrogenic injury Bowel perforation Complications associated with increased intra-abdominal pressure | 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. | Average of 50 minutes | 
| Postoperative complications | Postoperative complications will be recorded postoperative follow up. Bleeding Fecal leakage Intrabdominal injury Wound infection Port site hernia | 24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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appendicitis, laparoscopy, single incision