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Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

Primary Purpose

Acute Cholecystitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy
Sponsored by
South Valley University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cholecystitis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients diagnosed with acute cholecystitis beyond 72 hours of symptoms onset, American Society of Anesthesiologists (ASA) scores I - III, Aged 20-70 years, Agreement to complete the study Exclusion Criteria: Gallbladder polyp, common bile duct stones, acute biliary pancreatitis, cholangitis, perforated cholecystitis, biliary peritonitis, pregnancy

Sites / Locations

  • Mohammed Ahmed Omar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prolonged laparoscpic cholecystectomy

Delayed laparoscpic cholecystectomy

Arm Description

Patients received laparoscopic cholecystectomy for acute cholecystitis after 27 hours of symptoms

Patients received laparoscopic cholecystectomy for acute cholecystitis after 6 weeks of symptoms

Outcomes

Primary Outcome Measures

Overall morbidity
The overall morbidity included failure of initial conservative treatment, emergency consultation, unplanned hospital readmission for recurrent attacks of AC or gallstone-related complications, subtotal cholecystectomy, and intra- and postoperative complications

Secondary Outcome Measures

Morbidity
All intra and postoperative complications
Mortality
Death
Total length of hospital saty
Duration of hospitalization
Total Cost
The total cost includes the surgical and medical costs
Total antibiotic duration
Duration of antibiotic therapy
conversion rate
conversion from laparoscopic cholecystectomy to open cholecystectomy
Operative time
duration from first trocar incision to last stitch
Lost days of work
Lost days of work

Full Information

First Posted
February 9, 2023
Last Updated
June 3, 2023
Sponsor
South Valley University
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1. Study Identification

Unique Protocol Identification Number
NCT05736003
Brief Title
Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis
Official Title
Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis: Time to Change the Concept - A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Valley University

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
Gallbladder stone affects 10-15% of the adult population, and about 15-25% of these patients presented with acute cholecystitis (AC). Laparoscopic cholecystectomy (LC) is considered the treatment of choice for patients with AC, and recent studies suggest that early laparoscopic cholecystectomy (ELC) is preferable. However, the optimal time for ELC in AC is still controversial. Early laparoscopic cholecystectomy (ELC) was advised for patients presented within 72 hours, while conservative treatment and planned delayed laparoscopic cholecystectomy (DLC) after six weeks was recommended for patients presented after 72 hours. Surgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone for the DLC.
Detailed Description
Gallbladder stone affects 10-15% of the adult population, and about 15-25% of these patients presented with acute cholecystitis (AC). Laparoscopic cholecystectomy (LC) is considered the treatment of choice for patients with AC, and recent studies suggest that early laparoscopic cholecystectomy (ELC) is preferable. However, the optimal time for ELC in AC is still controversial. Early laparoscopic cholecystectomy (ELC) was advised for patients presented within 72 hours, while conservative treatment and planned delayed laparoscopic cholecystectomy (DLC) after six weeks was recommended for patients presented after 72 hours. ELC might be associated with a significant reduction in morbidity and mortality rates, comparable conversion rates, shorter hospital stays, lower costs, and higher patient satisfaction. Surgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone the DLC. Additionally, 15% of patients do not respond to the conservative treatment and still need an emergency cholecystectomy and another 25% of patients require re-hospitalization for recurrent attacks of AC and biliary colic, biliary pancreatitis, cholangitis, and calcular obstructive jaundice during the interval waiting for the DLC. Furthermore, DLC has a higher cost and is time-consuming. Prolonged LC (PLC) for AC after 3 days from onset of symptoms was thought to be more technically difficult and dangerous because of altered anatomo-pathology where suppurative and subsequently necrotizing cholecystitis develops after edematous cholecystitis during the first 2 to 4 days of symptoms, and this may be associated with increased perioperative complications and conversion rate. On the contrary, others believed that hyperemia and edema may help the dissection. All the studies in the literature focus on the ELC and DLC with little data regarding the safety and feasibility of LC for acute cholecystitis beyond 72 hours of symptoms. More clinical trials are needed for the optimal management of acute cholecystitis after 72 hours of symptoms. The aim of this study was to compare the clinical outcomes of prolonged and delayed LC in patients with acute cholecystitis more than 72 hours of symptoms.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
437 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolonged laparoscpic cholecystectomy
Arm Type
Experimental
Arm Description
Patients received laparoscopic cholecystectomy for acute cholecystitis after 27 hours of symptoms
Arm Title
Delayed laparoscpic cholecystectomy
Arm Type
Active Comparator
Arm Description
Patients received laparoscopic cholecystectomy for acute cholecystitis after 6 weeks of symptoms
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
Removal of gallbladder laparoscopically
Primary Outcome Measure Information:
Title
Overall morbidity
Description
The overall morbidity included failure of initial conservative treatment, emergency consultation, unplanned hospital readmission for recurrent attacks of AC or gallstone-related complications, subtotal cholecystectomy, and intra- and postoperative complications
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Morbidity
Description
All intra and postoperative complications
Time Frame
30 days
Title
Mortality
Description
Death
Time Frame
30 days
Title
Total length of hospital saty
Description
Duration of hospitalization
Time Frame
3 years
Title
Total Cost
Description
The total cost includes the surgical and medical costs
Time Frame
3 years
Title
Total antibiotic duration
Description
Duration of antibiotic therapy
Time Frame
3 years
Title
conversion rate
Description
conversion from laparoscopic cholecystectomy to open cholecystectomy
Time Frame
3 years
Title
Operative time
Description
duration from first trocar incision to last stitch
Time Frame
3 hours
Title
Lost days of work
Description
Lost days of work
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with acute cholecystitis beyond 72 hours of symptoms onset, American Society of Anesthesiologists (ASA) scores I - III, Aged 20-70 years, Agreement to complete the study Exclusion Criteria: Gallbladder polyp, common bile duct stones, acute biliary pancreatitis, cholangitis, perforated cholecystitis, biliary peritonitis, pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed A Omar, M.D.
Organizational Affiliation
General Surgery Department, Faculty of Medicine, South Valley University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohammed Ahmed Omar
City
Luxor
ZIP/Postal Code
83523
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication
IPD Sharing Time Frame
For 1 year
IPD Sharing Access Criteria
After publication

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Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

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