CClinicalTrials.gg
Not yet recruitingNCT06778928Updated Jan 16, 2025

Posterior Wall Sparing of Laparoscopic Cholecystectomy in Cirrhotic Patients

An observational study in Cholecystitis in Cirrhotic Patients, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-01-16.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cholecystitis in Cirrhotic Patients

Browse trials for

03

In context

Cholecystitis

266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.

This study's planned enrollment of 60 is below the median of 200 across 90 observational studies indexed under Cholecystitis.

Browse Cholecystitis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient with pervious abdominal surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • Procedurelaparoscopic cholecystectomy

    Posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients

06

What researchers measure

Primary outcomes

  1. Intra and Post-operative haemorrhage

    Time frame: Surgery then 2 days follow up

  2. Postoperative bile leak

    Time frame: Surgery then 1 week follow up

  3. Changes of liver function tests

    AST, ALT, Billirubin

    Time frame: Surgery then 1 week follow up

  4. Worsening of ascites

    Time frame: Surgery then 1 week follow up

  5. Port site infection

    Time frame: Surgery then 1 week folow up

Secondary outcomes

  1. Operative time

    Time frame: From the end of induction of anasthesia to the closure of port site incisions

  2. Postoperative hospital stay

    Time frame: surgery then up to 1 week hospital stay before discharge

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Shaikh AR, Muneer A. Laparoscopic cholecystectomy in cirrhotic patients. JSLS. 2009 Oct-Dec;13(4):592-6. doi: 10.4293/108680809X12589999537959. PubMed 20202403 ↗
  • 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. PubMed 16021366 ↗
  • 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. PubMed 16864026 ↗
  • 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. PubMed 32369724 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06778928
Lead sponsor
Assiut University
Responsible party
Adnan mohamed (Principal investigator, Assiut University) — Principal investigator
First posted
Jan 16, 2025
Start date
Jan 2025 (estimated)
Primary completion
Apr 1, 2026 (estimated)
Completion
Apr 1, 2026 (estimated)
Last update
Jan 16, 2025

Study contacts

Adnan mohamed Mohamed Mohamed salem
Contact
Adnan.16281240@med.aun.edu.eg
01111846484
Mostafa Mahmoud Mohamed Ibrahim, Lecturer
Contact
mostafamahmoud562@au.edu.eg
01095295794

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion