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

Not Applicable

Completed

• Conditions: Acute Appendicitis
• Interventions: Procedure: SILS appendectomy; Procedure: Three port laparoscopic appendectomy

• Registration Number: NCT01816568
• Lead Sponsor: Maltepe University

Brief 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. 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 Timeline

• Study Start: 2010-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-03
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-21
• Last Update Submitted: 2013-03-21
• Study First Posted: 2013-03-22
• Last Update Posted: 2013-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	SILS appendectomy	SILS appendectomy
Group 2	Three port laparoscopic appendectomy	Three port laparoscopic appendectomy

Primary Outcome Measures

Name	Time	Method
Pain score	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.

Secondary Outcome Measures

Name	Time	Method
Intraoperative complications	Average of 50 minutes	Per operative complications will be recorded.; * Bleeding; * Iatrogenic injury; * Bowel perforation; * Complications associated with increased intra-abdominal pressure
Operating time	Average of 50 minutes	The operating time will be defined as the time from the first incision to the last suture's placement.
Postoperative complications	24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year	Postoperative complications will be recorded postoperative follow up.; * Bleeding; * Fecal leakage; * Intrabdominal injury; * Wound infection; * Port site hernia