NCT01734720

Brief Summary

The aims of this study were to

  1. 1.investigate what measures were taken when common bile duct stones (CBDS) were found intraoperatively in Sweden during the period May 2005 to December 2009 by using data from this population-based nationwide registry, and
  2. 2.analyze the outcome in terms of complications and success rates of bile duct clearance in relation to various stone sizes and interventions used. In order to further characterize the natural course of CBDS of various sizes, particular interest was focused on patients with positive findings where no peroperative measures to clear the bile ducts were taken or planned postoperatively.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,828

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2005

Longer than P75 for all trials

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

May 1, 2005

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
Last Updated

August 29, 2013

Status Verified

August 1, 2013

Enrollment Period

4.6 years

First QC Date

November 16, 2012

Last Update Submit

August 28, 2013

Conditions

Common Bile Duct Stone

Outcome Measures

Primary Outcomes (1)

  • complications in relation to strategy for handling CBDS

    Complications reported to the registry at 30 day follow up after surgery

    30 days post operative

Secondary Outcomes (1)

  • complications in relation to stone size

    30 days post operative

Study Arms (1)

common bile duct stone

Patients undergoing cholecystectomy

Eligibility Criteria

Age11 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing cholecystectomy with common bile duct stones found in peroperative cholangiogram

You may qualify if:

  • common bile duct stones

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mats Möller, MD

    Karolinsks Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. consultant suregon, Ersta Hospital

Study Record Dates

First Submitted

November 16, 2012

First Posted

November 28, 2012

Study Start

May 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 29, 2013

Record last verified: 2013-08