Single-Incision Laparoscopic Cholecystectomy with Inflexible Laparoscopic Instruments and Laparoscopy: a Single-Center Experience

NCT06708390 | Completed

• 1 other identifier: 2024-1092
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Since being introduced by Mühe in 1985, laparoscopic cholecystectomy (LC) has garnered global acceptance and defined as gold standard treatment for benign gallbladder diseases (BGDs). Minimally invasive surgery technique was applied in a spectrum of surgeries including LC, namely single-incision laparoscopic cholecystectomy (SILC), initially reported by Navarra in 1997. By then this technique developed dramatically in aspects of both operation and instruments. Previous experiences with SILC across various centers have consistently demonstrated its robust safety and feasibility. Numerous clinical trials have highlighted the benefits of SILC over conventional laparoscopic cholecystectomy (CLC), particularly in terms of promoted aesthetic outcomes, reduced postoperative pain, and shorter hospital stays.However, discrepancies in postoperative complications including incisional hernias have sparked debate regarding the merits and drawbacks of SILC. Consequently, further research is urgent with larger cohorts and extended postoperative follow-up periods for a definitive assessment of SILC. In the present study LC was performed in cases from January 2023 to March 2024, aiming to compare the overall outcomes and complications between CLC and SILC. All surgical instruments and laparoscopy were introduced through a single intraumbilical incision in SILC group, allowing the resultant scar to be discreetly concealed within the reconstructed navel. Furthermore, historical implementations of SILC have predominantly utilized specialized and novel instruments. This reliance on special equipment limited the technique's applicability and benefits in settings with more rudimentary clinical facilities. The authors successfully applied conventional laparoscopic instruments and a 10mm laparoscopy with straight and inflexible properties and simplified the surgical process. Moreover, the single-incision port used were made on site from basic stuffs and materials easily obtained from operation room.

Conditions

Benign Gallbladder Disease

Keywords

single-incision laparoscopic; laparoscopic cholecystectomy; cholecystolithiasis

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  Postoperative complications were graded using Clavien-Dindo classification system .

  Six months postoperatively

Secondary Outcomes (2)

• Postoperative quality of life

  Six months postoperatively

• Scar assessment

  One month postoperatively

Study Arms (2)

SILC

single-incision laparoscopic cholecystectomy

CLC

conventional laparoscopic cholecystectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with benign gallbladder diseases

You may qualify if:

• Gallbladder stone；
• Acute cholecystitis；
• Chronic cholecystitis；
• Gallbladder adenomyomatosis；
• Gallbladder polyp.

You may not qualify if:

• Combined with liver cirrhosis (Child grade B and above)；
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, No.88 Jiefang Road, China

Location

MeSH Terms

Conditions

Cholecystolithiasis

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Officials

• Daren Liu, MD, PhD

  Chief Physician

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: November 23, 2024
• Primary Completion: February 17, 2025
• Study Completion: February 20, 2025
• Last Updated: March 27, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)