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Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis (ACC)

Primary Purpose

Acute Cholecystitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
from the onset of symptoms within the first 3 days
: from the onset of symptoms within the 4-7 days
from the onset of symptoms beyond 7 days
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cholecystitis focused on measuring Early laparoscopic cholecystectomy, postcholecystectomy bile injury, delay laparoscopic cholecystectomy

Eligibility Criteria

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

Inclusion Criteria:

ACC patients who underwent early LC

Exclusion Criteria:

Pregnancy, Acalculous cholecystitis, CBDS, Ascending cholangitis, Pancreatitis, ASA score 4, Patients scheduled for DLC with failed medical treatment.

Sites / Locations

  • Mohamed Attea

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

from the onset of symptoms within the first 3 days (group 1)

from the onset of symptoms within the 4-7 days

from the onset of symptoms beyond 7 days

Arm Description

ELC for ACC from the onset of symptoms within the first 3 days (group 1)

ELC for ACC from the onset of symptoms within the4-7 days (group II)

ELC for ACC from the onset of symptoms beyond 7 days (group III)

Outcomes

Primary Outcome Measures

the incidence of postoperative morbidity
the incidence of postoperative morbidity during the 30th day of postoperative procedure

Secondary Outcome Measures

conversion rate
conversion rate to open cholecystectomy
blood loss
blood loss
hospital stay
overall hospital stay

Full Information

First Posted
May 25, 2020
Last Updated
May 25, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04405713
Brief Title
Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis
Acronym
ACC
Official Title
Assessment of Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis (Multicentric Study)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura 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 ideal timing for ELC continues to be debatable in patients with acute calculator cholecystitis (ACC). This study was planned to identify the impact of different ELC timing in ACC on surgical outcomes in terms of safety and efficacy
Detailed Description
This multicentric analysis involved of successive patients with ACC ELC between April 2018 and March 2020. Patients were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2), and beyond 7 days (group 3). The primary outcome was the incidence of postoperative complications The secondary outcomes were conversion rate, blood loss, operative times, operational difficulty, the cost-benefit relationship, postoperative stay with each treatment line.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis
Keywords
Early laparoscopic cholecystectomy, postcholecystectomy bile injury, delay laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with ACC were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2) and beyond 7 days (group 3).
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Patients were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2) and beyond 7 days (group 3).
Allocation
Non-Randomized
Enrollment
900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
from the onset of symptoms within the first 3 days (group 1)
Arm Type
Active Comparator
Arm Description
ELC for ACC from the onset of symptoms within the first 3 days (group 1)
Arm Title
from the onset of symptoms within the 4-7 days
Arm Type
Active Comparator
Arm Description
ELC for ACC from the onset of symptoms within the4-7 days (group II)
Arm Title
from the onset of symptoms beyond 7 days
Arm Type
Active Comparator
Arm Description
ELC for ACC from the onset of symptoms beyond 7 days (group III)
Intervention Type
Procedure
Intervention Name(s)
from the onset of symptoms within the first 3 days
Other Intervention Name(s)
group 1
Intervention Description
ELC within 3 days of onset of ACC
Intervention Type
Procedure
Intervention Name(s)
: from the onset of symptoms within the 4-7 days
Other Intervention Name(s)
Group II
Intervention Description
ELC 4-7days of onset of ACC
Intervention Type
Procedure
Intervention Name(s)
from the onset of symptoms beyond 7 days
Other Intervention Name(s)
Group III
Intervention Description
ELC after 7days of onset of ACC
Primary Outcome Measure Information:
Title
the incidence of postoperative morbidity
Description
the incidence of postoperative morbidity during the 30th day of postoperative procedure
Time Frame
30 DAYS
Secondary Outcome Measure Information:
Title
conversion rate
Description
conversion rate to open cholecystectomy
Time Frame
INTRAOPERATIVE
Title
blood loss
Description
blood loss
Time Frame
intraoperative
Title
hospital stay
Description
overall hospital stay
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ACC patients who underwent early LC Exclusion Criteria: Pregnancy, Acalculous cholecystitis, CBDS, Ascending cholangitis, Pancreatitis, ASA score 4, Patients scheduled for DLC with failed medical treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman E Nakeeb
Organizational Affiliation
Mansoura University, Gastrointestinal Surgery Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohamed Attea
City
Mansoura
ZIP/Postal Code
356111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
plan to make individual participant data (
IPD Sharing Time Frame
6 months
IPD Sharing Access Criteria
elnakeebayman@yahoo.com
IPD Sharing URL
http://www.mans.edu.eg/en/
Citations:
PubMed Identifier
32425482
Citation
El Zanati H, Nassar AHM, Zino S, Katbeh T, Ng HJ, Abdellatif A. Gall Bladder Empyema: Early Cholecystectomy during the Index Admission Improves Outcomes. JSLS. 2020 Apr-Jun;24(2):e2020.00015. doi: 10.4293/JSLS.2020.00015.
Results Reference
result
PubMed Identifier
31388885
Citation
Mora-Guzman I, Di Martino M, Gancedo Quintana A, Martin-Perez E. Laparoscopic Cholecystectomy for Acute Cholecystitis: Is the Surgery Still Safe beyond the 7-Day Barrier? J Gastrointest Surg. 2020 Aug;24(8):1827-1832. doi: 10.1007/s11605-019-04335-5. Epub 2019 Aug 6. Erratum In: J Gastrointest Surg. 2021 Jan;25(1):337.
Results Reference
result
PubMed Identifier
30354853
Citation
Brunee L, Hauters P, Closset J, Fromont G, Puia-Negelescu S; Club Coelio. Assessment of the optimal timing for early laparoscopic cholecystectomy in acute cholecystitis: a prospective study of the Club Coelio. Acta Chir Belg. 2019 Oct;119(5):309-315. doi: 10.1080/00015458.2018.1529344. Epub 2018 Oct 25.
Results Reference
result
PubMed Identifier
28569137
Citation
Inoue K, Ueno T, Nishina O, Douchi D, Shima K, Goto S, Takahashi M, Shibata C, Naito H. Optimal timing of cholecystectomy after percutaneous gallbladder drainage for severe cholecystitis. BMC Gastroenterol. 2017 May 31;17(1):71. doi: 10.1186/s12876-017-0631-8.
Results Reference
result
PubMed Identifier
27785732
Citation
Onoe S, Kaneoka Y, Maeda A, Takayama Y, Fukami Y. Feasibility of laparoscopic cholecystectomy for acute cholecystitis beyond 72 h of symptom onset. Updates Surg. 2016 Dec;68(4):377-383. doi: 10.1007/s13304-016-0409-5. Epub 2016 Oct 26.
Results Reference
result
PubMed Identifier
26218858
Citation
Menahem B, Mulliri A, Fohlen A, Guittet L, Alves A, Lubrano J. Delayed laparoscopic cholecystectomy increases the total hospital stay compared to an early laparoscopic cholecystectomy after acute cholecystitis: an updated meta-analysis of randomized controlled trials. HPB (Oxford). 2015 Oct;17(10):857-62. doi: 10.1111/hpb.12449. Epub 2015 Jul 27.
Results Reference
result
Links:
URL
http://www.mans.edu.eg/en/
Description
Mansoura university
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://www.mans.edu.eg/en/
Available IPD/Information Identifier
Ayman El Nakeeb
Available IPD/Information Comments
elnakeebayman@yahoo.com

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Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis

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