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

Cholecystectomy, Laparoscopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728463
• Other study ID #: 2022-0533
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: February 6, 2025

Study information

• Verified date: February 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Daren Liu, MD, PhD
• Phone: +86-15968179036
• Email: darenliu[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 6, 2025
• Est. primary completion date: February 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholecystectomy, Laparoscopic
• Surgical Wound

Intervention

Procedure:
• Laparoscopic cholecystectomy
Laparoscopic cholecystectomy is defined as total or subtotal desection of the gallbladder laparoscopically.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (time to return to normal life)	The quality of life of patients after operation was investigated by a unified SF-36 questionnaire.	2 years
Secondary	Cosmetic result	Evaluation of postoperative incisional scarring using the Vancouver Scar Scale	2 years
Secondary	Grade II or above incidence of complications		2 years