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

Maltepe University

Status: Completed

Conditions: Gallbladder Disease

Treatments: Procedure: TPCL cholecystectomy; Procedure: SILS cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01772745

mütf3

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Group 1

Active Comparator group

Description:

SILS cholecystectomy

Treatment:

Procedure: SILS cholecystectomy

Group 2

Active Comparator group

Description:

TPCL cholecystectomy

Treatment:

Procedure: TPCL cholecystectomy