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Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? (RCT)

Primary Purpose

Acute Cholecystitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Early laparoscopic cholecystectomy
Late laparoscopic cholecystectomy
Sponsored by
Damanhour Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cholecystitis focused on measuring Acute cholecystitis, Early laparoscopic cholecystectomy, Gallbladder disease, Late laparoscopic cholecystectomy

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with AC within seven days from symptom onset
  • American Society of Anesthesiologist (ASA) physical status ≤ II
  • Age from 21 to 60 years

Exclusion Criteria:

  • Patients with ASA physical status > II
  • Age < 21 years or > 60 years
  • Child classification B or C
  • Choledocholithiasis
  • Acute pancreatitis
  • Severe sepsis
  • Gallbladder perforation
  • Pregnant women

Sites / Locations

  • Damanhour Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group E: Early LC (n=60)

Group L: Late LC (n=60)

Arm Description

Early laparoscopic cholecystectomy (within 72h from symptom onset)

Late laparoscopic cholecystectomy (after 72h up to seven days from symptom onset)

Outcomes

Primary Outcome Measures

Number of participants and Rate of Post-operative complications
Number of participants and Rate of: Post-operative bleeding, Fluid collection, Bile leak, Port-site infection, Revision surgery, Mortality rate

Secondary Outcome Measures

Mean and Standard deviation of Operative duration (hours) (mean±SD)
Mean and Standard deviation of Operative duration (hours)
Mean and Standard deviation of Intra-operative blood loss (ml) (mean±SD)
Mean and Standard deviation of Intra-operative blood loss (ml)
Number of participants and Rate of Conversion to open cholecystectomy
Number of participants and Rate of Conversion to open cholecystectomy
Mean and Standard deviation of Length of hospital stay (days) (mean±SD)
Mean and Standard deviation of Length of hospital stay (days)

Full Information

First Posted
June 23, 2019
Last Updated
June 26, 2019
Sponsor
Damanhour Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03999645
Brief Title
Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days?
Acronym
RCT
Official Title
Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damanhour Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Objectives: To compare the safety of early (≤72h) versus late (>72h-7days) laparoscopic cholecystectomy (LC) from symptom onset for acute cholecystitis (AC). Background: As LC within 72h of symptom onset was considered the optimum time, sometimes there was a delay in diagnosis and management. So, we raised the question of safety and feasibility of performing LC to patients with AC who failed to have LC within 72h of acute attack. Patients and Methods: This was a prospective, randomized, double-blind, clinical trial; carried out on 120 patients presented with AC between September 2017 and April 2019. Patients were randomly allocated into two equal groups assigned to LC; group E: within 72h of symptom onset, and group L: after 72h up to seven days from symptom onset.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis
Keywords
Acute cholecystitis, Early laparoscopic cholecystectomy, Gallbladder disease, Late laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group E: Early LC (n=60)
Arm Type
Active Comparator
Arm Description
Early laparoscopic cholecystectomy (within 72h from symptom onset)
Arm Title
Group L: Late LC (n=60)
Arm Type
Active Comparator
Arm Description
Late laparoscopic cholecystectomy (after 72h up to seven days from symptom onset)
Intervention Type
Procedure
Intervention Name(s)
Early laparoscopic cholecystectomy
Intervention Description
within 72h from symptom onset
Intervention Type
Procedure
Intervention Name(s)
Late laparoscopic cholecystectomy
Intervention Description
after 72h up to seven days from symptom onset
Primary Outcome Measure Information:
Title
Number of participants and Rate of Post-operative complications
Description
Number of participants and Rate of: Post-operative bleeding, Fluid collection, Bile leak, Port-site infection, Revision surgery, Mortality rate
Time Frame
30 days post-operatively
Secondary Outcome Measure Information:
Title
Mean and Standard deviation of Operative duration (hours) (mean±SD)
Description
Mean and Standard deviation of Operative duration (hours)
Time Frame
from surgical incision till suture closure
Title
Mean and Standard deviation of Intra-operative blood loss (ml) (mean±SD)
Description
Mean and Standard deviation of Intra-operative blood loss (ml)
Time Frame
from surgical incision till suture closure
Title
Number of participants and Rate of Conversion to open cholecystectomy
Description
Number of participants and Rate of Conversion to open cholecystectomy
Time Frame
from the start till the end of surgical procedure
Title
Mean and Standard deviation of Length of hospital stay (days) (mean±SD)
Description
Mean and Standard deviation of Length of hospital stay (days)
Time Frame
from hospital admission till home discharge within 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with AC within seven days from symptom onset American Society of Anesthesiologist (ASA) physical status ≤ II Age from 21 to 60 years Exclusion Criteria: Patients with ASA physical status > II Age < 21 years or > 60 years Child classification B or C Choledocholithiasis Acute pancreatitis Severe sepsis Gallbladder perforation Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed M Abdalgaleil, MD
Organizational Affiliation
Damanhour Teaching Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed M Shaat, MD
Organizational Affiliation
Damanhour Teaching Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Osama S Elbalky, MD
Organizational Affiliation
Damanhour Teaching Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mamdouh M Ibrahim, MD
Organizational Affiliation
Damanhour Teaching Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed S Elnagar, MD
Organizational Affiliation
Damanhour Teaching Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Damanhour Teaching Hospital
City
Damanhūr
State/Province
El-Beheira
Country
Egypt

12. IPD Sharing Statement

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Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days?

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