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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Gallbladder Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

SILS cholecystectomy

Group Type ACTIVE_COMPARATOR

SILS cholecystectomy

Intervention Type PROCEDURE

Single incision laparoscopic cholecystectomy will be performed

Group 2

TPCL cholecystectomy

Group Type ACTIVE_COMPARATOR

TPCL cholecystectomy

Intervention Type PROCEDURE

Three port laparoscopic cholecystectomy will br performed

Interventions

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SILS cholecystectomy

Single incision laparoscopic cholecystectomy will be performed

Intervention Type PROCEDURE

TPCL cholecystectomy

Three port laparoscopic cholecystectomy will br performed

Intervention Type PROCEDURE

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,
* Patients admitted outside working hours with acute cholecystitis,
* Patients have choledocolithiasis,
* pregnancy,
* ongoing peritoneal dialysis,
* lack of written informed consent.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes