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

January 17, 2013 updated by: manuk norayk manukyan, Maltepe University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Required laparoscopic cholecystectomy for gallbladder disease.

Exclusion Criteria:

  • American Society of Anesthesiologists score (ASA) more than III,
  • Patients had prior abdominal surgery,
  • Patients admitted outside working hours with acute cholecystitis,
  • Patients have choledocolithiasis,
  • pregnancy,
  • ongoing peritoneal dialysis,
  • lack of written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
SILS cholecystectomy
Procedure: SILS cholecystectomy
Single incision laparoscopic cholecystectomy will be performed
Active Comparator: Group 2
TPCL cholecystectomy
Procedure: TPCL cholecystectomy
Three port laparoscopic cholecystectomy will br performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative first 24 hours
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
Average of 70 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Average of 70 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Average of 2 days
Length of hospital stay will be recorded postoperative period.
Average of 2 days
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
  • Bile leakage
  • Intrabdominal injury
  • Wound infection
  • Port site hernia
24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maltepe University

Investigators

  • Principal Investigator: Umut Barbaros, Ass.Prof., Istanbul University, Istanbul Medical School, General Surgery Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 17, 2013

First Posted (Estimate)

January 21, 2013

Study Record Updates

Last Update Posted (Estimate)

January 21, 2013

Last Update Submitted That Met QC Criteria

January 17, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mütf3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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