Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis

NCT ID: NCT04405713

Last Updated: 2020-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2020-03-25

Brief Summary

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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

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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.

Conditions

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Acute Cholecystitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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).

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

from the onset of symptoms within the first 3 days

Intervention Type PROCEDURE

ELC within 3 days of onset of ACC

from the onset of symptoms within the 4-7 days

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

ELC 4-7days of onset of ACC

from the onset of symptoms beyond 7 days

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

Group Type ACTIVE_COMPARATOR

from the onset of symptoms beyond 7 days

Intervention Type PROCEDURE

ELC after 7days of onset of ACC

Interventions

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from the onset of symptoms within the first 3 days

ELC within 3 days of onset of ACC

Intervention Type PROCEDURE

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

ELC 4-7days of onset of ACC

Intervention Type PROCEDURE

from the onset of symptoms beyond 7 days

ELC after 7days of onset of ACC

Intervention Type PROCEDURE

Other Intervention Names

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group 1 Group II Group III

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Ayman El Nakeeb

gastrointestinal surgical center, Mansoura University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayman E Nakeeb

Role: PRINCIPAL_INVESTIGATOR

Mansoura University, Gastrointestinal Surgery Center

Locations

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Mohamed Attea

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 32425482 (View on PubMed)

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.

Reference Type RESULT
PMID: 31388885 (View on PubMed)

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.

Reference Type RESULT
PMID: 30354853 (View on PubMed)

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.

Reference Type RESULT
PMID: 28569137 (View on PubMed)

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.

Reference Type RESULT
PMID: 27785732 (View on PubMed)

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.

Reference Type RESULT
PMID: 26218858 (View on PubMed)

Study Documents

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Document Type: Study Protocol

[email protected]

View Document

Related Links

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http://www.mans.edu.eg/en/

Mansoura university

Other Identifiers

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early LC for ACC

Identifier Type: -

Identifier Source: org_study_id

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