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

Inclusion Criteria2

  • Age ranged from 18-80 years old
  • Patients with preoperative diagnosis of biliary colic, gallbladder polyps

Exclusion Criteria10

  • The American Society of Anesthesiologists'(ASA) physical status class IV and V
  • Patients with contraindication for laparoscopy
  • Patients with Mirizzi syndrome
  • Patient with suspected presence of common duct stones
  • Patients with suspected malignancy
  • Patients with previous upper abdominal surgery
  • Patients on long term anticoagulant treatment
  • Patients with previous history of cholangitis or cholecystitis
  • Patients with large gallstone >3cm
  • Patients with imaging diagnosis of contracted gallbladder or chronic cholecystitis

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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

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ACTRN12610000006044