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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-05-04

No results posted yet for this study

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

Interventions

PROCEDURE

lap fundus-calot cholecystectomy

use laparoscopic fundus-calot approach

PROCEDURE

open cholecystectomy

use open approach

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2018-01-01
Completion
2020-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04373447 on ClinicalTrials.gov