Role of Intra-Operative Aspiration in Distended GB in LC

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Calculous Cholecystitis; Gallbladder Empyema; Gallbladder Mucocele
• Intervention / Treatment: Procedure: Laparoscopic needle

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Aswān, Egypt
    • Aswan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aspiration group	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
No Intervention: Non-Aspiration group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difficulty of the operation	the difficulty will be assessed by the following Operative time, Incidence of biliary tree injury, Higher surgeon consultation and Conversion to open chole	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver bed bleeding	checking post procedures and postoperative through the drain	30 days
30-day mortality	follow-up the patient in the outpatient and by phone	30 days
Hospital stays.	total stay in the hospital	30 days
Peritonitis	incidence of peritonitis in the first week of the operation	30 days

Collaborators and Investigators

• Sponsor: Aswan University
• Investigators: Principal Investigator: Ali H Abdelaal, Faculty of medicine, Aswan university

Publications and helpful links

General Publications

• Barrat, C., Champault, A., Matthyssens, L., & Champault, G. (2004). L'effraction de la vésicule lors des cholécystectomies laparoscopiques n'influence pas la morbidité. Étude prospective. Annales de Chirurgie, 129(1), 25-29. https://doi.org/10.1016/j.anchir.2003.11.011
• Calik, A., Topaloglu, S., Topcu, S., Turkyilmaz, S., Kucuktulu, U., & Piskin, B. (2007). Routine intraoperative aspiration of gallbladder during laparoscopic cholecystectomy. Surgical Endoscopy and Other Interventional Techniques, 21(9), 1578-1581. https://doi.org/10.1007/s00464-006-9159-7 Guzmán-Valdivia, G. (2008). Routine Administration of Antibiotics to Patients Suffering Accidental Gallbladder Perforation During Laparoscopic Cholecystectomy is not Necessary. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques, 18(6), 547-550. https://doi.org/10.1097/SLE.0b013e3181809e72 Lee, K.-T., Shan, Y.-S., Wang, S.-T., & Lin, P.-W. (2005). Verres needle decompression of distended gallbladder to facilitate laparoscopic cholecystectomy in acute cholecystitis: A prospective study. Hepato-Gastroenterology, 52(65), 1388-1392. Lisotti, A., Linguerri, R., Bacchilega, I., Cominardi, A., Marocchi, G., & Fusaroli, P. (2022). EUS-guided gallbladder drainage in high-risk surgical patients with acute cholecystitis-Procedure outcomes and evaluation of mortality predictors. Surgical Endoscopy, 36(1), 569-578. https://doi.org/10.1007/s00464-021-08318-z Majumder, A., Altieri, M. S., & Brunt, L. M. (2020). How do I do it: Laparoscopic cholecystectomy. Annals of Laparoscopic and Endoscopic Surgery, 5, 15-15. https://doi.org/10.21037/ales.2020.02.06 Mishra, R. K. (2022, June 12). Cholecystectomy for Mucocele of Gallbladder. https://www.laparoscopyhospital.com/streamvideo/index.php?pid=536&p=28 Ponsky, J. L. (1991). Complications of laparoscopic cholecystectomy. The American Journal of Surgery, 161(3), 393-395. https://doi.org/10.1016/0002-9610(91)90605-D Shea, J. A., Berlin, J. A., Bachwich, D. R., Staroscik, R. N., Malet, P. F., McGuckin, M., Schwartz, J. S., & Escarce, J. J. (1998). Indications for and Outcomes of Cholecystectomy. Annals of Surgery, 227(3), 343-350. https://doi.org/10.1097/00000658-199803000-00005 Shirah, B. H., Shirah, H. A., & Albeladi, K. B. (2018). The value of intraoperative percutaneous aspiration of the mucocele of the gallbladder for safe laparoscopic management. Updates in Surgery, 70(4), 495-502. https://doi.org/10.1007/s13304-018-0565-x Siddiqui, M. R. S., Sajid, M. S., Nisar, A., Ali, H., Zaborszky, A., & Hasan, F. (2011). A meta-analysis of outcomes after routine aspiration of the gallbladder during cholecystectomy. International Surgery, 96(1), 21-27. https://doi.org/10.9738/1361.1 Usuba, T., Nyumura, Y., Takano, Y., Iino, T., & Hanyu, N. (2017). Clinical outcomes of laparoscopic cholecystectomy with accidental gallbladder perforation. Asian Journal of Endoscopic Surgery, 10(2), 162-165. https://doi.org/10.1111/ases.12348 Wood, S., Lewis, W., & Egan, R. (2019). Optimising Surgical Technique in Laparoscopic Cholecystectomy: A Review of Intraoperative Interventions. Journal of Gastrointestinal Surgery, 23(9), 1925-1932. https://doi.org/10.1007/s11605-019-04296-9

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): January 1, 2026
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Acute Calculous Cholecystitis; Gallbladder Empyema; Gallbladder Mucocele; Distended gallbladder; Intra-operative aspiration
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: Asw.Uni./978/9/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No