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NCT Number: NCT07378410

Role of Intra-Operative Aspiration in Distended GB in LC

Laparoscopic cholecystectomy (LC) is a standard procedure for gallstones and the standard surgical approach for acute calcular cholecystitis, superseding open cholecystectomy for gallbladder (GB) pathologies. Despite this progress, mortality rates in high-risk cohorts remain substantial, ranging between 3.7% and 41.0%. Moreover, the recommended modality for mucocele which is defined as distension and marked dilatation of the GB associated with dysfunction is LC.

The routine aspiration showed significant less percentage of GB perforation during surgery with similarity for other factors . However, routine aspiration of the GB during uncomplicated LC is considered an unnecessary intervention and therefore not recommended as a routine practice.

Accidental GB perforation occurs in about 20% of laparoscopic cholecystectomies, and bile contamination in the abdominal cavity can cause SSI and lead to the formation of a residual abscess or wound infection.

Grasping a thick and distended GB is one of the most common technical difficulties of laparoscopic cholecystectomy in acute cholecystitis. If the GB is distended it should be decompressed it to avoid conversion to open due to bile duct injury or perforation with spillage of bile and gallstones previously, authors had advocated conversion if iatrogenic perforation occurred.

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Key information

Conditions

Acute Calculous Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases Gallbladder Empyema Gallbladder Mucocele

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aswan University

Aswān, Egypt

About this study

This study was conducted on patients with symptomatic calcular cholecystitis presented to Aswan university hospital.

The following parameters were measured intraoperative difficulty.

  • Operative time
  • Incidence of biliary tree injury
  • Higher surgeon consultation
  • Conversion into open surgery All groups were followed up for 30 days period for post-operative complication clinically and by sonar.
  • Wound infection
  • Liver bed bleeding
  • Collection in the liver bed
  • Peritonitis
  • Hospital stays.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with calcular cholecystitis, GB mucocele or GB empyema
  • Distended gallbladder: shiny, over distended, long, difficult to grasp and manipulate gallbladder.
  • Acute or chronic calcular cholecystitis

Exclusion criteria

  • Obstructive jaundice
  • Non distended gallbladder
  • Previous upper abdomen operations
  • Pregnant

Treatment and study plan

Laparoscopic needle

Procedure

During classic LC, either with preoperative or accidently intra-operative overdistended GB using a laparoscopic needle to decompress the GB and make the operation much easier

Primary outcomes

  1. Difficulty of the operation

    Time frame: 30 days

    the difficulty will be assessed by the following Operative time, Incidence of biliary tree injury, Higher surgeon consultation and Conversion to open chole

Secondary outcomes

  1. Liver bed bleeding

    Time frame: 30 days

    checking post procedures and postoperative through the drain

  2. 30-day mortality

    Time frame: 30 days

    follow-up the patient in the outpatient and by phone

  3. Hospital stays.

    Time frame: 30 days

    total stay in the hospital

  4. Peritonitis

    Time frame: 30 days

    incidence of peritonitis in the first week of the operation

Sponsors and collaborators

Lead sponsor

Aswan University

Other

Registry information

Official study title

Outcomes of Intra-Operative Aspiration Vs Non-Aspiration for Distended Gallbladder in Laparoscopic Cholecystectomy

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

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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