NCT01865071

Brief Summary

Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer

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
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

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

September 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2012

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 5, 2014

Status Verified

February 1, 2014

Enrollment Period

4.1 years

First QC Date

October 11, 2012

Last Update Submit

February 4, 2014

Conditions

Rectal Cancer

Keywords

ileostomyrectal resectionproctectomystoma closurerectal cancer

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Death occurring during the first 90 postoperative days

    Death occurring during the first 90 days

Study Arms (1)

loop ileostomi

EXPERIMENTAL

Compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer

Procedure: loop ileostomi

Interventions

loop ileostomiPROCEDURE
loop ileostomi

Eligibility Criteria

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

You may qualify if:

  • All patients aged 18 years or older.
  • All patients with rectal carcinoma, requiring elective rectal resection with primary anastomosis and an protecting ileostoma
  • Written informed consent was obtained from all patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense Universityhospital

Odense, Fyn, 5000, Denmark

RECRUITING

Related Publications (1)

  • Ellebaek MB, Perdawood SK, Steenstrup S, Khalaf S, Kundal J, Moller S, Bang JC, Stovring J, Qvist N. Early versus late reversal of diverting loop ileostomy in rectal cancer surgery: a multicentre randomized controlled trial. Sci Rep. 2023 Apr 10;13(1):5818. doi: 10.1038/s41598-023-33006-4.

    PMID: 37037856DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Mark Ellebæk, MD

    Odense Universityhospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Ellebæk, MD

CONTACT

004540880511markep01@gmail.com

Study Design

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

Study Record Dates

First Submitted

October 11, 2012

First Posted

May 30, 2013

Study Start

September 1, 2011

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 5, 2014

Record last verified: 2014-02

Locations

DK(1)