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Early Versus Delayed Cholecystectomy

Primary Purpose

Acute Cholecystitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic cholecystectomy
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cholecystitis focused on measuring Laparoscopic Cholecystectomy, Delayed Cholecystectomy

Eligibility Criteria

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

Inclusion Criteria:

  • patients suffering acute cholecystitis in their first 72 hours of pain

Exclusion Criteria:

  • clinical duration longer than 72 hours, complicated acute cholecystitis (bilirubin >2gr/dl, elevated transaminases (>100 u/l), and cholestatic enzymes (gamma glutamyl transferase >50 u/l), ultrasonographically confirmed dilated intrahepatic or extrahepatic bile ducts, and elevated amylase levels three times more than normal range

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Group L (n:88)

    Group D (n:88)

    Arm Description

    patients treated surgically with laparoscopic cholecystectomy immediately

    patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy

    Outcomes

    Primary Outcome Measures

    Hospital stay
    time spent totally in the hospital; time from admission to discharge from hospital in days

    Secondary Outcome Measures

    Costs of treatment
    costs of treatment spent for surgery and hospital stay in days; costs of treatment from admission to discharge from hospital in USD

    Full Information

    First Posted
    March 28, 2017
    Last Updated
    April 23, 2017
    Sponsor
    Sisli Hamidiye Etfal Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03122054
    Brief Title
    Early Versus Delayed Cholecystectomy
    Official Title
    Should Surgical Experience Change Our Treatment Strategy on Acute Cholecystitis? Early Versus Delayed Cholecystectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2015 (Actual)
    Primary Completion Date
    November 1, 2016 (Actual)
    Study Completion Date
    February 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sisli Hamidiye Etfal Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study examines complications, mortality rates, cost-effectiveness and safety of early laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC). Group L (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy.
    Detailed Description
    There is only few knowledge about the comparison of early laparoscopic cholecystectomy (ELC) versus delayed laparoscopic cholecystectomy (DLC) for the treatment of acute cholecystitis considering the surgeon's work experience. This study examines complications, mortality rates, cost-effectiveness and safety of DLC versus ELC. This prospective randomized clinical trial was performed between November 2015-2016 in our General Surgery Clinic. Patients suffering acute cholecystitis in their first 72 hours of pain were enrolled in one of the two study groups: Group L (n:88) patients treated surgically with laparoscopic cholecystectomy immediately or Group D (n:88) patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy. All operations and medical treatments were done by surgeons having work experience <2 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Cholecystitis
    Keywords
    Laparoscopic Cholecystectomy, Delayed Cholecystectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    patients suffering acute pain because of acute cholecystitis
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    176 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group L (n:88)
    Arm Type
    Other
    Arm Description
    patients treated surgically with laparoscopic cholecystectomy immediately
    Arm Title
    Group D (n:88)
    Arm Type
    Other
    Arm Description
    patients first treated medically and than treated surgically with delayed (4-8 weeks later) laparoscopic cholecystectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic cholecystectomy
    Intervention Description
    First trocar was inserted with Hasson method (Subumbilical 1 cm vertical incision was made and first 10-mm trocar (VersaportTM plus V2, Covidien, USA) inserted under direct vision) and pneumoperitoneum was created with 12 mm Hg pressure. Second 10-mm trocar was inserted from subxyphoid area. Two 5-mm trocars were inserted in the right upper quadrant area. After general intrabdominal exploration, dissection was started to ensure safe-view of Calot triangle. In case of quite tough gallbladder for griping, gallbladder was drained with a gray intravenous cannula. Cystic artery and cystic duct were separately dissected and twice ligated with Endo Clip™ II ML (Covidien, USA). Gallbladder was dissected from liver bed carefully. Gallbladder was taken out from abdomen through the subumbilical incision.
    Primary Outcome Measure Information:
    Title
    Hospital stay
    Description
    time spent totally in the hospital; time from admission to discharge from hospital in days
    Time Frame
    4 to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Costs of treatment
    Description
    costs of treatment spent for surgery and hospital stay in days; costs of treatment from admission to discharge from hospital in USD
    Time Frame
    4 to 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients suffering acute cholecystitis in their first 72 hours of pain Exclusion Criteria: clinical duration longer than 72 hours, complicated acute cholecystitis (bilirubin >2gr/dl, elevated transaminases (>100 u/l), and cholestatic enzymes (gamma glutamyl transferase >50 u/l), ultrasonographically confirmed dilated intrahepatic or extrahepatic bile ducts, and elevated amylase levels three times more than normal range
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Riza Gurhan Isil, MD
    Organizational Affiliation
    Sağlık Bilimleri Üniversitesi Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    I can share study data only without sharing patient names and protocol numbers.
    Citations:
    PubMed Identifier
    22570746
    Citation
    Stinton LM, Shaffer EA. Epidemiology of gallbladder disease: cholelithiasis and cancer. Gut Liver. 2012 Apr;6(2):172-87. doi: 10.5009/gnl.2012.6.2.172. Epub 2012 Apr 17.
    Results Reference
    background
    PubMed Identifier
    20035546
    Citation
    Gurusamy K, Samraj K, Gluud C, Wilson E, Davidson BR. Meta-analysis of randomized controlled trials on the safety and effectiveness of early versus delayed laparoscopic cholecystectomy for acute cholecystitis. Br J Surg. 2010 Feb;97(2):141-50. doi: 10.1002/bjs.6870. Erratum In: Br J Surg. 2010 Apr;97(4):624.
    Results Reference
    result

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    Early Versus Delayed Cholecystectomy

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