Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06074679

Clinical Study of Single Incision Laparoscopic Cholecystectomy in the Treatment of Patients With Acute Cholecystitis

Gallstone is a common disease in China.At present, the prevalence of gallstones in China is 15 %, and about 210 million people are sick. Acute cholecystitis is acute gallbladder inflammation, is one of the main complications of cholelithiasis or gallstones. The removal of gallbladder and gallstones in patients with acute cholecystitis in the presence of biliary pain will prevent the recurrence of gallbladder and reduce the risk of cholecystitis progression. If gallbladder perforation is not treated in time, the mortality rate is 30 %. Acute acalculous cholecystitis without treatment will be life-threatening, with a mortality rate of up to 50 %. At present, the vast majority of patients with acute cholecystitis are treated with 4-hole traditional laparoscopic cholecystectomy and open cholecystectomy. Their postoperative quality of life, pain and scar-related complications, remain major factors for patients.In recent years, with the renewal of the concept of minimally invasive surgery and the continuous advancement of instruments and technology, single-incision laparoscopic cholecystectomy has also maximized the quality of life after surgery and reduced postoperative pain and scar-related complications. At present, there are few reports on randomized controlled clinical trials of SILC in patients with acute cholecystitis, and there is a lack of large sample size studies.Due to the difficulty of SILC operation, the longer learning curve, the different equipment conditions and technical characteristics of each center, and the lack of standardized training, there is no effective consensus on the application indications and operation procedures of SILC in acute cholecystitis surgery. Based on the current status, the purpose of this study was to investigate the effect of SILC on postoperative quality of life, postoperative pain, scar assessment and postoperative complications in patients with acute cholecystitis, so as to propose a standardized single incision laparoscopic operation procedure in the treatment of acute cholecystitis.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University, Huangshan City, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Acute cholecystitis(GradeⅠ,II)

Exclusion criteria

  • Combined with liver cirrhosis (Child grade B and above)
  • Upper abdominal surgical history;
  • 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

Open cholecystectomy

Procedure

The experimental group and the control group were changed to open cholecystectomy when the operation was difficult to complete.

Primary outcomes

  1. Quality of life (time to return to normal life)

    Time frame: 3 years

    The quality of life of patients after operation was investigated by a unified SF-36 questionnaire. The higher the final score, the better the quality of life.

Secondary outcomes

  1. Cosmetic result

    Time frame: 3 years

    Evaluation of postoperative incisional scarring using the Vancouver Scar Scale. The lower the score, the higher the scar satisfaction.

Other outcomes

  1. Grade II or above incidence of complications

    Time frame: 3 years

    Postoperative complications were defined by the clavien-dindo classification system.

Study contacts

Contact information is provided by the study sponsor or research team.

Liu Daren, MD, PhD

CONTACT

[email protected]

+86-15968179036

Zha Liufan, MD, PhD

CONTACT

[email protected]

+86-18969952245

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Changxing Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Jiande Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Shexian Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Suichang Branch, Second Affiliated Hospital, School of Medicine, Zhejiang University

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
Nov 21, 2024

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.

Published trials that share one or more normalized conditions with this study.