NCT02972944

Brief Summary

Cholecystectomy is the only curative treatment for gallstone disease of acute calculous cholecystitis.The purpose of this study is to find the most effective treatment (laparoscopic cholecystectomy vs. conservative) for elderly patients with acute cholecystitis. Therefore a randomized multi-centre study of 200 elderly patients suffering from acute cholecystitis is performed with additional cohort of all elderly patients with acute cholecystitis in the study hospitals during study period.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 20, 2021

Status Verified

February 1, 2021

Enrollment Period

5.2 years

First QC Date

November 8, 2016

Last Update Submit

October 13, 2021

Conditions

Cholecystitis, Acute

Outcome Measures

Primary Outcomes (1)

  • Specific Morbidity Index Scores

    The primary outcome is morbidity, all complications will be scored (according to "morbidity-index" -chart) (ref: Gutt et al: Ann Surg 2013;258:385-393)

    1 year postoperatively

Secondary Outcomes (7)

  • Quality of life RAND-36 scores

    pre-operatively and 1 year postoperatively

  • Pain scores (0-100)

    pre-operatively, 1 week, 1 month and 1 year postoperatively

  • Number of patients with failure of antibiotic therapy

    1 week, 1 month and 1 year postoperatively

  • Time of hospitalization (days)

    1 month

  • Mortality (number of patients)

    1 month

  • +2 more secondary outcomes

Study Arms (2)

Cholecystectomy group

EXPERIMENTAL

Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization.

Procedure: Laparoscopic cholecystectomy

Non-operative group

ACTIVE COMPARATOR

Patients of non-operative group will be treated conservatively with intravenous antibiotics (cefuroxime) at surgical ward. Elective cholecystectomy will not be arranged.

Procedure: Non-operative treatment

Interventions

Laparoscopic cholecystectomyPROCEDURE
Cholecystectomy group
Non-operative treatmentPROCEDURE
Non-operative group

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Radiologically confirmed acute cholecystitis
  • Age over 75 yrs
  • American Association of Anesthesiologists Classification class 2-3
  • Duration of symptoms \< 5 days

You may not qualify if:

  • American Association of Anesthesiologists Classification class 4-5
  • Age under 75 yrs
  • Peritonitis
  • Sepsis or septic shock
  • Duration of symptoms over 6 days
  • Cholestasis or diagnosed stone at common biliary duct.
  • Acute Pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70200, Finland

RECRUITING

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Central Study Contacts

Hannu Paajanen, Professor

CONTACT

17 173 311Hannu.Paajanen@kuh.fi

Antti Kivivuori, MD

CONTACT

443516698Antti.Kivivuori@esshp.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 25, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

October 20, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)