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Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy.

Primary Purpose

Cholecystitis, Acute

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 treatment trial for Cholecystitis, Acute

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age less than 70 years.
  2. fit for surgery.

Exclusion Criteria:

  1. patients with co-existent common bile duct stones based on imaging and biochemical criteria.
  2. Patients with Pancreatitis .
  3. Patients with previous upper abdominal surgery.
  4. Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g.Chronic Pulmonary Disease, significant Cardiac Disease)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy

    Arm Description

    A Prospective Randomized Comparative Study.

    Outcomes

    Primary Outcome Measures

    Incidence of intraoperative complications in urgent versus elective lap cholecystostomy.
    Collect results and see.

    Secondary Outcome Measures

    Incidence of postoperative complications in urgent versus elective lap cholecystectomy.
    Collect results and see.

    Full Information

    First Posted
    August 6, 2022
    Last Updated
    August 13, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05502744
    Brief Title
    Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy.
    Official Title
    Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy: A Prospective Randomized Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 14, 2022 (Anticipated)
    Primary Completion Date
    September 14, 2022 (Anticipated)
    Study Completion Date
    August 14, 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
    The aim of study is compare outcome of patients undergoing early laparoscopic cholecystectomy within 72 hours from the begging of symptoms to those of patients managed conservatively and operated late after 6-8weeks after the inflammatory reaction has subsided.
    Detailed Description
    Acute cholecystitis is considered one of the most common acute surgical problems. It includes typical symptoms of pain in right hypochondrium, fever, increased leucocytes count and abdominal US used to confirm this clinical diagnosis. Laparoscopic cholecystectomy (LC) is the standard treatment for acute cholecystitis due to the advantages of small wounds, less use of abdominal drains , less need for antibiotics and analgesics and less postoperative hospital stay time.Laparoscopic cholecystectomy in acute cholecystitis may be performed as soon as begging of the symptoms called emergency or urgent laparoscopic cholecystectomy and maybe scheduled in advance after controlling acute attack after 6-8weeks called elective laparoscopic cholecystectomy . Emergency laparoscopic cholecystectomy has advantage of a decreased hospital stay and avoids the risk of emergency admission for non-resolved or recurrent symptoms, which is associated with an increase in morbidity, pain and delayed return to work. Also, some trials showed increased morbidity with elective laparoscopic cholecystectomy mostly due to biliary disease while patients await surgery. Comparative studies are deficient in evaluation of outcomes of emergency cholecystectomy and elective cholecystectomy in acute cholecystitis. So the interest of our study is to compare between the emergency laparoscopic cholecystectomy and elective laparoscopic cholecystectomy regarding the feasibility and the safety of the first.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cholecystitis, Acute

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy
    Arm Type
    Experimental
    Arm Description
    A Prospective Randomized Comparative Study.
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic cholecystectomy
    Other Intervention Name(s)
    Emergency versus elective cholecystectomy in acute cholecystits in the era of laproscopy
    Intervention Description
    Laparoscopic cholecystectomy is the standard treatment for acute cholecystitis due to the advantages of small wounds, less use of abdominal drains , less need for antibiotics and analgesics and less postoperative hospital stay time.Laparoscopic cholecystectomy in acute cholecystitis may be performed as soon as begging of the symptoms called emergency or urgent and maybe scheduled in advance after controlling acute attack after 6-8weeks called elective.
    Primary Outcome Measure Information:
    Title
    Incidence of intraoperative complications in urgent versus elective lap cholecystostomy.
    Description
    Collect results and see.
    Time Frame
    Intraoperative time
    Secondary Outcome Measure Information:
    Title
    Incidence of postoperative complications in urgent versus elective lap cholecystectomy.
    Description
    Collect results and see.
    Time Frame
    6 months.

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age less than 70 years. fit for surgery. Exclusion Criteria: patients with co-existent common bile duct stones based on imaging and biochemical criteria. Patients with Pancreatitis . Patients with previous upper abdominal surgery. Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g.Chronic Pulmonary Disease, significant Cardiac Disease)

    12. IPD Sharing Statement

    Learn more about this trial

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