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Role of Intra-Operative Aspiration in Distended GB in LC

A

Aswan University

Status and phase

Completed
Phase 3

Conditions

Acute Calculous Cholecystitis
Gallbladder Mucocele
Gallbladder Empyema

Treatments

Procedure: Laparoscopic needle

Study type

Interventional

Funder types

Other

Identifiers

NCT07378410
Asw.Uni./978/9/24

Details and patient eligibility

About

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.

Full description

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.

Enrollment

70 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

70 participants in 2 patient groups

Aspiration group
Experimental group
Treatment:
Procedure: Laparoscopic needle
Non-Aspiration group
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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