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

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.

Study Overview

• Status: Completed
• Conditions: Benign Gallbladder Disease

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, No.88 Jiefang Road
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People with benign gallbladder diseases

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
SILC; single-incision laparoscopic cholecystectomy
CLC; conventional laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Postoperative complications were graded using Clavien-Dindo classification system .	Six months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative quality of life	The quality of life of patients after operation was evaluated according to SF-36 。Scores in 0 to 100, the higher the score, the higher the quality of life.	Six months postoperatively
Scar assessment	Scar assessment was conducted postoperatively using Vancouver Scar Scale.The highest score was 18 points, and the lowest score was 0 points. The higher the score, the more serious the scar condition, and vice versa.	One month postoperatively

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Daren Liu, MD, PhD, Chief Physician

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2024
• Primary Completion (Actual): February 17, 2025
• Study Completion (Actual): February 20, 2025

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopic cholecystectomy; cholecystolithiasis; single-incision laparoscopic
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases
• Other Study ID Numbers: 2024-1092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No