Laparoscopic Cholecystectomy:
Primary Purpose
Cholecystitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic cholecystectomy
Sponsored by
About this trial
This is an interventional other trial for Cholecystitis
Eligibility Criteria
Inclusion Criteria:
- Age of patient between 25 and 65 years
- Diagnosis of chronic cholecystitis, symptomatic cholelithiasis
Exclusion Criteria:
- Choledocholithiasis
- Severe Acute Calculus Pancreatitis
- Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia) 4 . Previous operation or adhesion
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
3 ports
4 port
Arm Description
3port operation
4 port operation
Outcomes
Primary Outcome Measures
compare between the prognosis of three port and four port laproscpic cholecyctectomy
Secondary Outcome Measures
Full Information
NCT ID
NCT04107909
First Posted
September 25, 2019
Last Updated
September 26, 2019
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT04107909
Brief Title
Laparoscopic Cholecystectomy:
Official Title
Three-port Versus Four-port Laparoscopic Cholecystectomy: A Prospective Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 30, 2019 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Various modifications have been tried in laparoscopic cholecystectomy since its introduction. One, two and three port LC have been performed on limited scale. we aim to compare three port LC with four port LC in patients with cholelithiasis. The main objective of this study is to evaluate the outcome of 3 ports LC for treatment of cholelithiasis by comparing the result with 4 ports LC with respect to safety and efficacy.
Detailed Description
Various modifications have been tried in laparoscopic cholecystectomy since its introduction. One, two and three port LC have been performed on limited scale. we aim was to compare three port LC with four port LC in patients with cholelithiasis. The main objective of this study was to evaluate the outcome of 3 ports LC for treatment of cholelithiasis by comparing the result with 4 To study the efficacy and feasibility of 3 port and 4 port lap cholecystetctomy.
1. To compare the intraoperative and post-operative complications of 3 port and 4 port lap cholecystectomy
Operative time,
Days of hospital stay.
complication
post-operative pain ports LC with respect to safety and efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3 ports
Arm Type
Other
Arm Description
3port operation
Arm Title
4 port
Arm Type
Other
Arm Description
4 port operation
Intervention Type
Procedure
Intervention Name(s)
laparoscopic cholecystectomy
Intervention Description
Both four port and three port LC is performed With the patient in supine position, with the surgeon and assistant on the left side and the monitor on the right side. Head up and right up position is employed during surgery in both the groups. Pneumoperitoneum of 12mmHg is created using open Hassan's method through the umbilical port.
In 3 port a 5.5 mm umbilical visiport for 5 mm lens 30 degree A second 10 mm trocar is placed inferior to the sternum at the midline, while the third 5mm trocar is placed 4-5cm inferior to the right costal margin on the right midclavicular line. For the four port LC, additional 5mm port is placed in the sub costal region at the anterior axillary line. Posterior dissection and delineation of The Calot's triangle is done. Then, the cystic artery and cystic duct are identified, isolated, doubly clipped and divided. The gallbladder is removed through the umbilical port using a 10mm gallbladder extractor.
Primary Outcome Measure Information:
Title
compare between the prognosis of three port and four port laproscpic cholecyctectomy
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of patient between 25 and 65 years
Diagnosis of chronic cholecystitis, symptomatic cholelithiasis
Exclusion Criteria:
Choledocholithiasis
Severe Acute Calculus Pancreatitis
Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia) 4 . Previous operation or adhesion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohammed ali
Phone
002101020832073
Email
mahamedelshreef1993@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
1838946
Citation
Muhe E. [Laparoscopic cholecystectomy--late results]. Langenbecks Arch Chir Suppl Kongressbd. 1991:416-23. doi: 10.1007/978-3-642-95662-1_189. German.
Results Reference
background
PubMed Identifier
782269
Citation
Traverso LW. Carl Langenbuch and the first cholecystectomy. Am J Surg. 1976 Jul;132(1):81-2. doi: 10.1016/0002-9610(76)90295-6.
Results Reference
background
PubMed Identifier
12799892
Citation
Trichak S. Three-port vs standard four-port laparoscopic cholecystectomy. Surg Endosc. 2003 Sep;17(9):1434-6. doi: 10.1007/s00464-002-8713-1. Epub 2003 Jun 13.
Results Reference
background
Learn more about this trial
Laparoscopic Cholecystectomy:
We'll reach out to this number within 24 hrs