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Laparoscopic Cholecystectomy:

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04107909
Collaborator
(none)
100
Enrollment
2
Arms
47.7
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparoscopic cholecystectomy
 N/A

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

  2. Operative time,

  3. Days of hospital stay.

  4. complication

  5. post-operative pain ports LC with respect to safety and efficacy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Other
Official Title:
Three-port Versus Four-port Laparoscopic Cholecystectomy: A Prospective Comparative Study
Anticipated Study Start Date :
Dec 30, 2019
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: 3 ports

3port operation

Procedure: laparoscopic cholecystectomy
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.
Other: 4 port

4 port operation

Procedure: laparoscopic cholecystectomy
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.

Outcome Measures

Primary Outcome Measures

  1. compare between the prognosis of three port and four port laproscpic cholecyctectomy [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age of patient between 25 and 65 years

  2. Diagnosis of chronic cholecystitis, symptomatic cholelithiasis

Exclusion Criteria:

  1. Choledocholithiasis

  2. Severe Acute Calculus Pancreatitis

  3. Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia) 4 . Previous operation or adhesion

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Ali Abdelfatah Elshreef, general surgery, Assiut University
ClinicalTrials.gov Identifier:
NCT04107909
Other Study ID Numbers:
  • lapgb
First Posted:
Sep 27, 2019
Last Update Posted:
Sep 27, 2019
Last Verified:
Sep 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cholecystitis

Study Results

No Results Posted as of Sep 27, 2019