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

Zhejiang University

Status: Completed

Conditions: Cholecystectomy, Laparoscopic

Treatments: Procedure: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05728463

2022-0533

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,000 participants in 2 patient groups

Single-incision laparoscopic cholecystectomy

Experimental group

Description:

SILC was defined as laparoscopic surgery done through a single trans-umbilical incision

Treatment:

Procedure: Laparoscopic cholecystectomy

Conventional laparoscopic cholecystectomy

Active Comparator group

Description:

CLC was defined as three or four port surgery carried out with either French or American position.

Treatment:

Procedure: Laparoscopic cholecystectomy