NCT00964379

Brief Summary

This is a prospective randomized trial of intraperitoneal versus extraperitoneal techniques for construction of terminal iliac fossa colostomies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 1988

Longer than P75 for phase_3

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, 1988

Completed
21.6 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2009

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 24, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

25.4 years

First QC Date

August 11, 2009

Last Update Submit

November 11, 2013

Conditions

Colostomy

Keywords

Intra versus extraperitoneal colostomy

Outcome Measures

Primary Outcomes (1)

  • parastomal hernia, stoma dysfunction

    7 years

Study Arms (2)

intraperitoneal colostomy

ACTIVE COMPARATOR
Procedure: intraperitoneal or extraperitoneal colostomy

extraperitoneal colostomy

ACTIVE COMPARATOR
Procedure: intraperitoneal or extraperitoneal colostomy

Interventions

intraperitoneal or extraperitoneal colostomyPROCEDURE

creation of colostomy

extraperitoneal colostomyintraperitoneal colostomy

Eligibility Criteria

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

You may qualify if:

  • permanent colostomy

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Infusions, Parenteral

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 24, 2009

Study Start

January 1, 1988

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

US(1)