Laparoscopic Cholecystectomy is no More Risky in Emergent Cases With in Cardiopulmonary Risk: Fundus-Callot Cholecystectomy With Low Pressure Pneumo-peritoneum VS Open Cholecystectomy

NCT04373447 | Completed DMC

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

Brief Summary

Introduction: In the last decades and due to improvement of medical heath care, large number of elderly persons were prevalence. Old age usually had cardiopulmonary different diseases. Biliary problems are high in old age. advancement of laparoscopic that occurred in the last years made the use of laparoscopy is available in these cardiopulmonary risk patients. many studies faced the role of laparoscopy in acute cholecystitis in elderly but no studies stated a new and a safe laparoscopic approach to the patients. Aim: compare between Fundus-Calot cholecystectomy with low pressure pneumo-peritoneum VS open cholecystectomy in Emergency cases with cardiopulmonary risk patients as regard intraoperative data and postoperative complications. Patients and methods: This study prospective randomized controlled study was conducted on 374 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-Calot approach (235cases) and Group B (235cases): classical open approach

Conditions

Laparoscopy

Outcome Measures

Primary Outcomes (1)

• duration of operation

  in minutes

  2 hours

Study Arms (2)

fundus-calot laparoscopic cholecystectomy

ACTIVE COMPARATOR

use laparoscopic fundus first then calot dissection cholecystectomy

Procedure: lap fundus-calot cholecystectomy

open cholecystectomy

ACTIVE COMPARATOR

open cholecystectomy

Procedure: open cholecystectomy

Interventions

lap fundus-calot cholecystectomy PROCEDURE

use laparoscopic fundus-calot approach

fundus-calot laparoscopic cholecystectomy

open cholecystectomy PROCEDURE

use open approach

open cholecystectomy

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 neurological, renal and Liver disease.
• Previous percutaneous cholecystostomy
• Cases not tolerated CO2 insufflation from the start.
• Other associated problems as acute cholangitis, pancreatitis, gastro-intestinal cancer or bile duct diseases

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

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 29, 2020
• First Posted: May 4, 2020
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2020
• Last Updated: May 4, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)