NCT01873638

Brief Summary

Minlaparotomy (MC) and laparoscopic cholecystoctomy (LC) are commonly applied surgical techniques for the management of symptomatic gallstone disease and both techiques have shown to be feasible for day surgery. However, to our knowledge the long-term outcome between these approaches has not been compared in randomised trials as day surgery procedures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2006

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

February 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
Last Updated

June 10, 2013

Status Verified

June 1, 2013

Enrollment Period

2.2 years

First QC Date

June 4, 2013

Last Update Submit

June 7, 2013

Conditions

Gallstone Disease

Keywords

5-year outcome after cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Chronic post-surgical pain

    Five year outcome

Secondary Outcomes (1)

  • Quality of life

    Five year outcome

Other Outcomes (2)

  • Cosmetic satisfaction

    Five year outcome

  • Residual abdominal symptoms

    Five year outcome

Study Arms (2)

Minilaparotomy

OTHER

Minilaparotomy cholecystectomy as a day surgery

Procedure: Cholecystectomy

Laparoscopy

OTHER

Laparoscopic cholecystectomy as a day surgery

Procedure: Cholecystectomy

Interventions

CholecystectomyPROCEDURE
LaparoscopyMinilaparotomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cholelithiasis confirmed by preoperative ulrasound
  • No significant co-morbidities
  • The ASA physical status classification 1 or 2
  • Age 18 to 65 yrs.
  • BMI less than 35
  • Less than a one hour journey from hospital to home
  • Patient´s own motivation to daysurgery

You may not qualify if:

  • Elevated liver laboratory tests
  • Earlier jaundice
  • A suspicion or verified stones in the common bile duct
  • Acute cholecystitis
  • A history of pancreatitis
  • Hepatic cirrhosis
  • Suspicion of cancer
  • Previous open upper abdominal surgery
  • Asthma
  • Peptic ulcer
  • Bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Location

MeSH Terms

Conditions

Cholelithiasis

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

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

June 4, 2013

First Posted

June 10, 2013

Study Start

February 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

June 10, 2013

Record last verified: 2013-06

Locations

FI(1)