Clinical trial NCT06778928: Posterior Wall Sparing of Laparoscopic Cholecystectomy in Cirrhotic Patients
Official title: Posterior Wall Sparing of Laparoscopic Cholecystectomy in Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cholecystitis in Cirrhotic Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 cirrhotic patients age from 18 to 60 years who were admitted for cholecystectomy

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intra and Post-operative haemorrhage
timeFrame: Surgery then 2 days follow up
measure: Postoperative bile leak
timeFrame: Surgery then 1 week follow up
measure: Changes of liver function tests
timeFrame: Surgery then 1 week follow up
measure: Worsening of ascites
timeFrame: Surgery then 1 week follow up
measure: Port site infection
timeFrame: Surgery then 1 week folow up
Secondary outcomes:
measure: Operative time
timeFrame: From the end of induction of anasthesia to the closure of port site incisions
measure: Postoperative hospital stay
timeFrame: surgery then up to 1 week hospital stay before discharge
Other outcomes:
Locations:
Study officials:
References:
citation: Shaikh AR, Muneer A. Laparoscopic cholecystectomy in cirrhotic patients. JSLS. 2009 Oct-Dec;13(4):592-6. doi: 10.4293/108680809X12589999537959.
citation: 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.
citation: 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.
citation: 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.