search
Back to results

Laparoscopic Cholecystectomy:

Primary Purpose

Cholecystitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic cholecystectomy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cholecystitis

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    September 25, 2019
    Last Updated
    September 26, 2019
    Sponsor
    Assiut University
    search

    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