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NCT Number: NCT06778928

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic cholecystectomy

Procedure

Posterior wall sparing of laparoscopic cholecystectomy in cirrhotic patients

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

    Time frame: Surgery then 1 week follow up

    AST, ALT, Billirubin

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Adnan mohamed Mohamed Mohamed salem

CONTACT

[email protected]

01111846484

Mostafa Mahmoud Mohamed Ibrahim, Lecturer

CONTACT

[email protected]

01095295794

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.