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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 2013

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.

Interventions

  • Procedure: SILS appendectomy
    • Single incision laparoscopic appendectomy will be performed
  • Procedure: Three port laparoscopic appendectomy
    • Three port laparoscopic appendectomy will be performed

Arms, Groups and Cohorts

  • Active Comparator: Group 1
    • SILS appendectomy
  • Active Comparator: Group 2
    • Three port laparoscopic appendectomy

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Intraoperative complications
    • Time Frame: Average of 50 minutes
    • Per operative complications will be recorded. Bleeding Iatrogenic injury Bowel perforation Complications associated with increased intra-abdominal pressure
  • Operating time
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Maltepe University
  • Provider of Information About this Clinical Study
    • Principal Investigator: manuk norayk manukyan, Assoc.Prof. – Maltepe University
  • Overall Official(s)
    • 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
    • Sertan Kapakli, Assoc.Prof., Principal Investigator, Maltepe University School of Medicine, General Surgery Department
    • Abut Kebudi, Prof., Study Chair, Maltepe University School of Medicine, General Surgery Department

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