Laparoscopy Clinical Trial
Official title:
Emergency Laparoscopic Cholecystectomy With Low Pressure Pneumo-peritoneum in Cardiopulmonary Risk Patients: Fundus First Cholecystectomy VS Calot First Cholecystectomy .Randomized Controlled Trials.
Verified date | April 2020 |
Source | Zagazig University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2 |
Est. completion date | March 1, 2020 |
Est. primary completion date | March 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility |
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 Liver disease. - Previous percutaneous cholecystostomy - Cases not tolerated CO2 insufflation from the start. |
Country | Name | City | State |
---|---|---|---|
Egypt | Tamer Alsaied Alnaimy | Zagazig | Sharkia |
Egypt | Tamer Alsaied Alnaimy | Zagazig | Sharkia |
Lead Sponsor | Collaborator |
---|---|
Zagazig University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | duration of operation in minutes | time taken to complete the surgery in minutes | 2 hours | |
Secondary | stricture of the biliary tract | stenosed bile duct that induce jaundice on laboratory investigations | 2 years |
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