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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

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

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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

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

hospital stay

overall hospital stay

Full Information

NCT ID

NCT04405713

First Posted

May 25, 2020

Last Updated

May 25, 2020

Sponsor

Mansoura University

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

Learn more about this trial

Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis

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