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Role of Intra-Operative Aspiration in Distended GB in LC

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07378410
Enrollment
70
Registered
2026-01-30
Start date
2023-07-01
Completion date
2026-01-01
Last updated
2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Calculous Cholecystitis, Gallbladder Empyema, Gallbladder Mucocele

Keywords

Acute Calculous Cholecystitis, Gallbladder Empyema, Gallbladder Mucocele, Distended gallbladder, Intra-operative aspiration

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.

Interventions

PROCEDURELaparoscopic 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

Aswan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants agreed to participate in the study and undergo the LC

Intervention model description

comparing the efficacy of intra-operative Gallbladder content aspiration in overdistended cases with completion of the operation without aspiration

Eligibility

Sex/Gender
ALL
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 * Pregnant

Design outcomes

Primary

MeasureTime frameDescription
Difficulty of the operation30 daysthe difficulty will be assessed by the following Operative time, Incidence of biliary tree injury, Higher surgeon consultation and Conversion to open chole

Secondary

MeasureTime frameDescription
Liver bed bleeding30 dayschecking post procedures and postoperative through the drain
30-day mortality30 daysfollow-up the patient in the outpatient and by phone
Hospital stays.30 daystotal stay in the hospital
Peritonitis30 daysincidence of peritonitis in the first week of the operation

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORAli H Abdelaal

Faculty of Medicine, Aswan University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026