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OpenTrials
Completed

NCT Number: NCT06708390

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hangzhou, Zhejiang, No.88 Jiefang Road, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Postoperative complications

    Time frame: Six months postoperatively

    Postoperative complications were graded using Clavien-Dindo classification system

    .

Secondary outcomes

  1. Postoperative quality of life

    Time frame: Six months postoperatively

    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.

  2. Scar assessment

    Time frame: One month postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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