NCT04405713

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

1.9 years

First QC Date

May 25, 2020

Last Update Submit

May 25, 2020

Conditions

Acute Cholecystitis

Keywords

Early laparoscopic cholecystectomypostcholecystectomy bile injurydelay laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • the incidence of postoperative morbidity

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

    30 DAYS

Secondary Outcomes (3)

  • conversion rate

    INTRAOPERATIVE

  • blood loss

    intraoperative

  • hospital stay

    30 days

Study Arms (3)

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

ACTIVE COMPARATOR

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

Procedure: from the onset of symptoms within the first 3 days

from the onset of symptoms within the 4-7 days

ACTIVE COMPARATOR

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

Procedure: : from the onset of symptoms within the 4-7 days

from the onset of symptoms beyond 7 days

ACTIVE COMPARATOR

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

Procedure: from the onset of symptoms beyond 7 days

Interventions

from the onset of symptoms within the first 3 daysPROCEDURE

ELC within 3 days of onset of ACC

Also known as: group 1
from the onset of symptoms within the first 3 days (group 1)
: from the onset of symptoms within the 4-7 daysPROCEDURE

ELC 4-7days of onset of ACC

Also known as: Group II
from the onset of symptoms within the 4-7 days
from the onset of symptoms beyond 7 daysPROCEDURE

ELC after 7days of onset of ACC

Also known as: Group III
from the onset of symptoms beyond 7 days

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ACC patients who underwent early LC

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Attea

Al Mansurah, 356111, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 32425482RESULT

  • 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.

    PMID: 31388885RESULT

  • 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.

    PMID: 30354853RESULT

  • 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.

    PMID: 28569137RESULT

  • 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.

    PMID: 27785732RESULT

  • 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.

    PMID: 26218858RESULT

Related Links

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Ayman E Nakeeb

    Mansoura University, Gastrointestinal Surgery Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
gastrointestinal surgical center, Mansoura University

Study Record Dates

First Submitted

May 25, 2020

First Posted

May 28, 2020

Study Start

April 1, 2018

Primary Completion

March 1, 2020

Study Completion

March 25, 2020

Last Updated

May 28, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will share

plan to make individual participant data (

Shared Documents
STUDY PROTOCOL
Time Frame
6 months
Access Criteria
elnakeebayman@yahoo.com
More information

Available IPD Datasets

Study Protocol (Ayman El Nakeeb)Access

Locations

EG(1)