NCT04187235

Brief Summary

This is a non-randomised case-controlled prospective study of consecutive patients with parastomal hernia, comparing the laparoscopic Keyhole repair with the modified Sugarbaker repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 1997

Longer than P75 for all trials

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

January 1, 1997

Completed
19 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2015

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

19 years

First QC Date

December 3, 2019

Last Update Submit

December 3, 2019

Conditions

Parastomal Hernia

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Recurrence of parastomal hernia

    3 years

Secondary Outcomes (2)

  • Mesh-related morbidity

    3 years

  • Postoperative complications

    30 days after surgery

Study Arms (2)

Keyhole rapair

74 patients who undervent parastomal hernia repair with keyhole technique 1997-2009

Procedure: Laparascopic repair of parastomal hernia

Sugarbaker repair

61 patients who undervent parastomal henia repair a.m. Sugarbaker 2009-2015

Procedure: Laparascopic repair of parastomal hernia

Interventions

Laparascopic repair of parastomal herniaPROCEDURE

Laparascopic repair of parastomal hernia

Keyhole rapairSugarbaker repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with parastomal hernia referred to Aarhus University Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Study Officials

  • Paul Wara, DMSc

    Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 5, 2019

Study Start

January 1, 1997

Primary Completion

December 30, 2015

Study Completion

December 30, 2015

Last Updated

December 5, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

We have no permission to share individual participant data with 3rd parties

Locations

DK(1)