Emergency Laparoscopic Cholecystectomy With Low Pressure Pneumo-peritoneum in Cardiopulmonary Risk Patients: Fundus First Cholecystectomy VS Calot First Cholecystectomy .

NCT04368611 | Completed DMC

• 1 other identifier: lap cholecystectomy 1
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

Introduction: Laparoscopic cholecystectomy is the usual approach in dealing with cholithiasis that greatly replace open approach even in acute emergency gall bladder diseases. Laparoscopic approach has great advantages than open approach but the biliary injuries are higher in laparoscopic approach than open approach. Laparoscopic approach is condemned for many years in cardiopulmonary risk patients because of its adverse impacts on cardiopulmonary systems. Performing laparoscopic cholecystectomy with low pressure pneumoperitoneum may be effective in treatment of acute gall bladder disease but with fundus first approach than classical Calot first approach. Aim: compare between initial Fundus first cholecystectomy followed by Calot dissection VS Calot only cholecystectomy in Emergency laparoscopic cholecystectomy with low pressure pneumo-peritoneum in cardiopulmonary risk patients as regard intraoperative data and postoperative complications. Patients and methods: This study prospective randomized controlled study was conducted on 470 cases with acute cholecystitis, biliary colic, mucocele and pyocele of gall bladder in emergency general surgery department. Patients were divided into 2 groups, Group A: fundus first group (235cases) and Group B (235cases): classical Calot first approach.

Conditions

Laparoscopy; Biliary Disease

Keywords

laparoscopy; cholecystectomy

Outcome Measures

Primary Outcomes (1)

• duration of operation in minutes

  time taken to complete the surgery in minutes

  2 hours

Secondary Outcomes (1)

• stricture of the biliary tract

  2 years

Study Arms (2)

fundus first cholecystectomy

ACTIVE COMPARATOR

start with fundus dissection then complete the dissection

Procedure: start with fundus

Calot first dissection

ACTIVE COMPARATOR

start and complete the dissection by dissection of Calot triangle

Procedure: calot first dissection

Interventions

start with fundus PROCEDURE

fundus first dissection then complete cholecystectomy as usual

fundus first cholecystectomy

calot first dissection PROCEDURE

start dissection by calot approach

Calot first dissection

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: any age.
• Sex: Male and Non pregnant female.
• Patients with cardiopulmonary diseases.
• Patients who diagnose acute cholecystitis not improving on medical treatment for 48 hours.
• Patients with biliary colic, mucocele of gall bladder and pyocele of gall bladder.
• American Society of Anesthesiologist's (ASA) score: grade I, II, III.

You may not qualify if:

• ASA grade IV
• Patients refuse surgery.
• Documented Liver disease.
• Previous percutaneous cholecystostomy
• Cases not tolerated CO2 insufflation from the start.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (2)

Tamer Alsaied Alnaimy

Zagazig, Sharqia Province, 055, Egypt

Location

Tamer Alsaied Alnaimy

Zagazig, Sharqia Province, 1234, Egypt

Location

MeSH Terms

Conditions

Gallbladder Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professour

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: March 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)