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Clinical Trials/NCT05728463
NCT05728463
Completed
Not Applicable

Single Incision Laparoscopic Cholecystectomy Compared with Conventional Laparoscopic Cholecystectomy, a Randomized Controlled Clinical Study

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country1,000 target enrollmentFebruary 6, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cholecystectomy, Laparoscopic
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
1000
Locations
1
Primary Endpoint
Quality of life (time to return to normal life)
Status
Completed
Last Updated
last year

Overview

Brief Summary

Laparoscopic cholecystectomy has been accepted and is nowadays considered as the gold standard treatment of gallstones disease. Conventional laparoscopic cholecystectomy (CLC) was defined as three or four port surgery carried out with either French or American position. It reduced post-operative pain and shorten post-operative length of stay compared with open cholecystectomy in a great extent. Single-incision laparoscopic cholecystectomy (SILC) as a revolutionized surgery, the main reason for its widespread use being the following: less post-operative pain, faster recovery, better cosmetics and quicker return to full activities, all resulting in the improvement of post-operative quality of life. SILC uses the umbilicus as a natural orifice allowing easy access to peritoneal cavity, easy conversion to standard laparoscopy and its easy closure, has been widely introduced into the clinical practice for benign gallbladder diseases. SILC can easily hide the surgical scar inside the umbilicus, thus has better cosmetic effect. But the real clinical benefits for patients still remain a matter of debate. In the last 5 years, many studies on SILC have been published, trying to answer the question whether such a new approach is worthwhile or not and whether is safe and cost-effective.Based on the above controversy, we conduct a RCT comparing clinical and peri-operative outcomes, such as quality of life (QOL), of SILC and CLC with the intent to assess the actual indications of the single-incision approach.

Registry
clinicaltrials.gov
Start Date
February 6, 2023
End Date
January 2, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Benign gallbladder disease

Exclusion Criteria

  • Combined with liver cirrhosis (Child grade B and above)
  • Upper abdominal surgical history;
  • Gallbladder gangrene perforation;
  • Changes in surgical plan (conversion to laparotomy,cholangiography, bile duct exploration, bile duct injury repair, abscess clearance, multivisceral resection.)
  • patients and their families do not agree with the treatment lost follow-up

Outcomes

Primary Outcomes

Quality of life (time to return to normal life)

Time Frame: 2 years

The quality of life of patients after operation was investigated by a unified SF-36 questionnaire.

Secondary Outcomes

  • Cosmetic result(2 years)
  • Grade II or above incidence of complications(2 years)

Study Sites (1)

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