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Role of Intra-Operative Aspiration in Distended GB in LC

NCT07378410 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-01-30

No results posted yet for this study

Summary

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.

Conditions

  • Acute Calculous Cholecystitis
  • Gallbladder Empyema
  • Gallbladder Mucocele

Interventions

PROCEDURE

Laparoscopic needle

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

Sponsors & Collaborators

  • Aswan University

    lead OTHER

Principal Investigators

  • Ali H Abdelaal · Faculty of Medicine, Aswan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2026-01-01
Completion
2026-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07378410 on ClinicalTrials.gov