Outcomes of Intra-Operative Aspiration Vs Non-Aspiration for Distended Gallbladder in Laparoscopic Cholecystectomy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Aswan University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Difficulty of the operation
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participants agreed to participate in the study and undergo the LC
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Aspiration group
Intervention: Laparoscopic needle (Procedure)
Non-Aspiration group
Outcomes
Primary Outcomes
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
- Liver bed bleeding(30 days)
- 30-day mortality(30 days)
- Hospital stays.(30 days)
- Peritonitis(30 days)
Investigators
Ali Hussein Abdelaal
Master degree candidate and Resident of General Surgery
Aswan University