NCT06778928

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 16, 2025

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

October 11, 2024

Last Update Submit

January 11, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

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

Posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients

Posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patient with pervious abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

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

    PMID: 20202403BACKGROUND
  • 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.

    PMID: 16021366BACKGROUND
  • 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.

    PMID: 16864026BACKGROUND
  • 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.

    PMID: 32369724BACKGROUND

MeSH Terms

Interventions

Cholecystectomy, Laparoscopic

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Central Study Contacts

Adnan mohamed Mohamed Mohamed salem

CONTACT

Mostafa Mahmoud Mohamed Ibrahim, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 11, 2024

First Posted

January 16, 2025

Study Start

January 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

January 16, 2025

Record last verified: 2024-10