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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000006044
Enrollment
46
Registered
2010-01-06
Start date
2009-12-20
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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

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

Sponsors

Yih Chun Ling Patricia
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026