NCT03999645

Brief Summary

Objectives: To compare the safety of early (≤72h) versus late (\>72h-7days) laparoscopic cholecystectomy (LC) from symptom onset for acute cholecystitis (AC). Background: As LC within 72h of symptom onset was considered the optimum time, sometimes there was a delay in diagnosis and management. So, we raised the question of safety and feasibility of performing LC to patients with AC who failed to have LC within 72h of acute attack. Patients and Methods: This was a prospective, randomized, double-blind, clinical trial; carried out on 120 patients presented with AC between September 2017 and April 2019. Patients were randomly allocated into two equal groups assigned to LC; group E: within 72h of symptom onset, and group L: after 72h up to seven days from symptom onset.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2019

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

1.7 years

First QC Date

June 23, 2019

Last Update Submit

June 26, 2019

Conditions

Acute Cholecystitis

Keywords

Acute cholecystitisEarly laparoscopic cholecystectomyGallbladder diseaseLate laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Number of participants and Rate of Post-operative complications

    Number of participants and Rate of: Post-operative bleeding, Fluid collection, Bile leak, Port-site infection, Revision surgery, Mortality rate

    30 days post-operatively

Secondary Outcomes (4)

  • Mean and Standard deviation of Operative duration (hours) (mean±SD)

    from surgical incision till suture closure

  • Mean and Standard deviation of Intra-operative blood loss (ml) (mean±SD)

    from surgical incision till suture closure

  • Number of participants and Rate of Conversion to open cholecystectomy

    from the start till the end of surgical procedure

  • Mean and Standard deviation of Length of hospital stay (days) (mean±SD)

    from hospital admission till home discharge within 30 days

Study Arms (2)

Group E: Early LC (n=60)

ACTIVE COMPARATOR

Early laparoscopic cholecystectomy (within 72h from symptom onset)

Procedure: Early laparoscopic cholecystectomy

Group L: Late LC (n=60)

ACTIVE COMPARATOR

Late laparoscopic cholecystectomy (after 72h up to seven days from symptom onset)

Procedure: Late laparoscopic cholecystectomy

Interventions

Early laparoscopic cholecystectomyPROCEDURE

within 72h from symptom onset

Group E: Early LC (n=60)
Late laparoscopic cholecystectomyPROCEDURE

after 72h up to seven days from symptom onset

Group L: Late LC (n=60)

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with AC within seven days from symptom onset
  • American Society of Anesthesiologist (ASA) physical status ≤ II
  • Age from 21 to 60 years

You may not qualify if:

  • Patients with ASA physical status \> II
  • Age \< 21 years or \> 60 years
  • Child classification B or C
  • Choledocholithiasis
  • Acute pancreatitis
  • Severe sepsis
  • Gallbladder perforation
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damanhour Teaching Hospital

Damanhūr, El-Beheira, Egypt

Location

MeSH Terms

Conditions

Cholecystitis, AcuteGallbladder Diseases

Condition Hierarchy (Ancestors)

CholecystitisBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Mohamed M Abdalgaleil, MD

    Damanhour Teaching Hospital

    PRINCIPAL INVESTIGATOR

  • Ahmed M Shaat, MD

    Damanhour Teaching Hospital

    PRINCIPAL INVESTIGATOR

  • Osama S Elbalky, MD

    Damanhour Teaching Hospital

    STUDY DIRECTOR

  • Mamdouh M Ibrahim, MD

    Damanhour Teaching Hospital

    STUDY CHAIR

  • Mohamed S Elnagar, MD

    Damanhour Teaching Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2019

First Posted

June 27, 2019

Study Start

September 1, 2017

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

June 27, 2019

Record last verified: 2019-06

Locations

EG(1)