Clinical Trial: The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy

Brief Summary: Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. Laparoscopic cholecystectomy has been recognized since 1987 as the gold standard procedure for gallbladder surgery. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study we aimed to compare results of SILS cholecystectomy and three port conventional laparoscopic (TPCL) cholecystectomy prospectively

Detailed Summary:

Single-incision laparoscopic procedures have evolved gradually to include a multitude of various surgeries. The current literature documents the use of a single-incision or single-port access surgery for cholecystectomies, adrenalectomies, splenectomies, appendectomies, herniorrhaphies, bariatrics, and colon surgery.

Total of 100 patients who undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to undergo SILS cholecystectomy group (n = 50) or TPCL cholecystectomy group (n= 50) according to a computer-generated table of random numbers. Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, indication for operation, need for conversion to a standard or three port laparoscopic cholecystectomy, need for conversion to an open cholecystectomy will be recorded. Outcome measures include operative morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of bile leak, wound infection, hospital readmission, and hernia.


Sponsor: Maltepe University

Current 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.
  • Intraoperative complications [ Time Frame: Average of 70 minutes ]

    Per operative complications will be recorded.

    • Bleeding
    • Gallbladder perforation
    • Bile leakage
    • Bowel perforation
    • Complications associated with increased intra-abdominal pressure


Original Primary Outcome: Same as current

Current Secondary Outcome: Operating time [ Time Frame: Average of 70 minutes ]

The operating time will be defined as the time from the first incision to the last suture's placement.


Original Secondary Outcome: Same as current

Information By: Maltepe University

Dates:
Date Received: January 16, 2013
Date Started: January 2010
Date Completion:
Last Updated: January 17, 2013
Last Verified: January 2013