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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04373447
Recruitment Status : Completed
First Posted : May 4, 2020
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Tamer Alsaied Alnaimy, Zagazig University

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


Condition or disease Intervention/treatment Phase
Laparoscopy Procedure: lap fundus-calot cholecystectomy Procedure: open cholecystectomy Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Cholecystectomy is no More Risky in Emergent Cases With in Cardiopulmonary Risk: Fundus-Callot Cholecystectomy With Low Pressure Pneumo-peritoneum VS Open Cholecystectomy - Randomized Controlled Trials
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2020

Arm Intervention/treatment
Active Comparator: fundus-calot laparoscopic cholecystectomy
use laparoscopic fundus first then calot dissection cholecystectomy
Procedure: lap fundus-calot cholecystectomy
use laparoscopic fundus-calot approach

Active Comparator: open cholecystectomy
open cholecystectomy
Procedure: open cholecystectomy
use open approach




Primary Outcome Measures :
  1. duration of operation [ Time Frame: 2 hours ]
    in minutes



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373447


Locations
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Egypt
Tamer Alsaied Alnaimy
Zagazig, Sharkia, Egypt, 055
Tamer Alsaied Alnaimy
Zagazig, Sharkia, Egypt, 1234
Sponsors and Collaborators
Zagazig University
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Responsible Party: Tamer Alsaied Alnaimy, assistant professour, Zagazig University
ClinicalTrials.gov Identifier: NCT04373447    
Other Study ID Numbers: lap cholecystectomy 2
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases