Posterior Wall Sparing of Laparoscopic Cholecystectomy in Cirrhotic Patients

To assess the outcome of posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients in Assuit university hospitals and El Rajhi hospital.

Study Overview

• Status: Not yet recruiting
• Conditions: Cholecystitis in Cirrhotic Patients
• Intervention / Treatment: Procedure: laparoscopic cholecystectomy

Detailed Description

Cholelithiasis is found in about one third of patients with liver cirrhosis and about twice as much as in the overall population. Predisposing factors for that include functional gallbladder alterations (reduced motility and decreased emptying), reduction in bile acidity, increased unconjugated bilirubin secretion, increased levels of estrogen, and increased intravascular haemolysis due to hypersplenism. Symptomatic biliary stones in patients with liver cirrhosis are associated with higher morbidity and mortality rates than those in patients with a non-cirrhotic liver. laparoscopic cholecystectomy is the gold standard for the treatment of most of gallbladder problems because of its several advantages over open cholecystectomy including shorter convalescence period and hospital stay. Furthermore, considering its safety, it is the gold-standard procedure in selected patients with symptomatic cholelithiasis and hepatic cirrhosis, especially Child-Pugh score A and B patients. Separation of posterior wall of the gallbladder from the liver bed in cirrhotic individuals is difficult and risky during a laparoscopic cholecystectomy surgery because of high-risk gall bladder bed due to fibrosis and tortuous, dilated vessels there so the strategy is leaving the posterior wall intact with the liver and the remnant mucosa was removed either by mucosectomy in patients with acute cholecystitis or by electro fulguration in those with chronic cholecystitis.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Adnan mohamed Mohamed Mohamed salem; Phone Number: 01111846484; Email: Adnan.16281240@med.aun.edu.eg
• Study Contact Backup: Name: Mostafa Mahmoud Mohamed Ibrahim, Lecturer; Phone Number: 01095295794; Email: mostafamahmoud562@au.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

60 cirrhotic patients age from 18 to 60 years who were admitted for cholecystectomy

Description

Inclusion Criteria:

• Patient age 18 - 60 years old Child A and B cirrhotic patients with Cholelithiasis Patient fit for surgery

Exclusion Criteria:

• Patient with pervious abdominal surgery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients; To assess the outcome of posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patient	Procedure: laparoscopic cholecystectomy; Posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra and Post-operative haemorrhage		Surgery then 2 days follow up
Postoperative bile leak		Surgery then 1 week follow up
Changes of liver function tests	AST, ALT, Billirubin	Surgery then 1 week follow up
Worsening of ascites		Surgery then 1 week follow up
Port site infection		Surgery then 1 week folow up

Secondary Outcome Measures

Outcome Measure	Time Frame
Operative time	From the end of induction of anasthesia to the closure of port site incisions
Postoperative hospital stay	surgery then up to 1 week hospital stay before discharge

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Shaikh AR, Muneer A. Laparoscopic cholecystectomy in cirrhotic patients. JSLS. 2009 Oct-Dec;13(4):592-6. doi: 10.4293/108680809X12589999537959.
• Schiff J, Misra M, Rendon G, Rothschild J, Schwaitzberg S. Laparoscopic cholecystectomy in cirrhotic patients. Surg Endosc. 2005 Sep;19(9):1278-81. doi: 10.1007/s00464-004-8823-z. Epub 2005 Jul 21.
• Palanivelu C, Rajan PS, Jani K, Shetty AR, Sendhilkumar K, Senthilnathan P, Parthasarthi R. Laparoscopic cholecystectomy in cirrhotic patients: the role of subtotal cholecystectomy and its variants. J Am Coll Surg. 2006 Aug;203(2):145-51. doi: 10.1016/j.jamcollsurg.2006.04.019. Epub 2006 Jun 22.
• Cassinotti E, Baldari L, Boni L, Uranues S, Fingerhut A. Laparoscopic Cholecystectomy in the Cirrhotic: Review of Literature on Indications and Technique. Chirurgia (Bucur). 2020 Mar-Apr;115(2):208-212. doi: 10.21614/chirurgia.115.2.208.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: January 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 11, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholecystitis
• Other Study ID Numbers: cholecystectomy cirrhotic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No