RecruitingACTRN12610000006044

Prospective randomized trial of single port laparoscopic cholecystectomy versus four ports laparoscopic cholecystectomy in patients with gallbladder stones

Prospective randomized trial of single port laparoscopic cholecystectomy versus four ports laparoscopic cholecystectomy in patients with gallbladder stones, to assess differences in pain


Sponsor

Yih Chun Ling Patricia

Enrollment

46 participants

Start Date

Dec 20, 2009

Study Type

Interventional

Conditions

Summary

The aim of this prospective randomized controlled trial is to compare the clinical outcome of single port laparoscopic cholecystectomy versus conventional four ports laparoscopic cholecystectomy in patients with gallbaldder stones or polyps. Hypothesis: single port laparoscopic cholecystectomy has advantage of decreased scarring, decreased incisional pain, shorter hospitalization and faster functional recovery.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two ways to remove a gallbladder laparoscopically (keyhole surgery): the traditional four-port method (four small cuts) versus a newer single-port method (just one cut through the belly button). The goal is to see if the single-port approach leads to less scarring, less pain, a shorter hospital stay, and faster recovery. You may be eligible if: - You are between 18 and 80 years old - You have been diagnosed with gallstones (biliary colic) or gallbladder polyps - You are suitable for keyhole surgery You may NOT be eligible if: - You have very high surgical risk (ASA class IV or V) - You have a reason you cannot have laparoscopic surgery - You have a suspected blockage in the main bile duct or suspected gallbladder cancer - You have had previous upper abdominal surgery - You take long-term blood-thinning medicines - You have a history of gallbladder infection (cholecystitis) or bile duct infection (cholangitis) - You have gallstones larger than 3cm Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Single port laparoscopic cholecystectomy: All operations were performed under general anaesthesia in the supine position with the operating surgeon on the patient’s left side. The sub-umbilical incis

Single port laparoscopic cholecystectomy: All operations were performed under general anaesthesia in the supine position with the operating surgeon on the patient’s left side. The sub-umbilical incision 20 mm in size was made by open technique. SILS (trademark) Port (Covidien) was inserted then. The SILS (trademark) Port is a flexible laparoscopic port that can accommodate up to three instruments through a single incision. The abdominal cavity was insufflated to a pneumoperitoneum of 12mmHg, and a 30 degrees laparoscope was then inserted. The patients were placed in a reverse Trendelenburg position, with the right side elevated. Instruments were then inserted through the rest of two 5 mm channels. The principal of surgery is same as the conventional 4-ports approach. Calot’s triangle was retracted under the help of two slings of sutures over the fundus and Hartman’s pouch. The cystic artery was dissected and transected after bipolar diathermy coagulation. The cystic duct was dissected and transected after endo-clips or endo-tie control. The gallbladder was dissected from gallbladder bed. The specimen was placed inside the retrieval bag and removed through the sub-umbilical port. Approximate duration 1 hour


Locations(1)

Hong Kong

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12610000006044