Skip to content

Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

Early Closure of Temporary Loop Ileostomy After Rectal Resection for Cancer

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01865071
Enrollment
150
Registered
2013-05-30
Start date
2011-09-30
Completion date
2015-10-31
Last updated
2014-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

ileostomy, rectal resection, proctectomy, stoma closure, rectal cancer

Brief summary

Early Closure of Temporary Loop Ileostomy After Rectal Resection for cancer

Detailed description

The aim of this prospective randomized study is to compare early vs. late closer of the protecting ileostoma in patients requiring rectal resection for rectal cancer. Early closer is defined as postoperative days 8-12 and delayed as later then 3 months. Inclusion criteria is aged 18 years or older with rectal carcinoma, requiring rectal resection with a protecting ileostoma. A CT-water-soluble contrast enema examination per rectum is performed at day 7, to evaluate the anastomosis in all patients. The patients will be randomized after the intention-to-treat principle, before the primary operation. If there is no radiologic signs of contrast leakage ore other contraindications for early closer as septic episodes ore missing bowl movements the early closure will be preformed. Primary end point is the rate of either postoperative death or postoperative complications occurring at 90 days after the rectal resection. Major and minor postoperative complications (anastomotic leakage, post operative death, anastomotic fistula, postoperative peritonitis, pneumonia etc) and stoma related complications (prolapsus or peristomial eventration, erosive peristomal dermatitis, dehydration with hydroelectrolytic disorders, occlusive syndrome) would be registered. LARS score and EORTC QLQ-30 will be sent preoperatively and after 3, 6, 12 and 24 months postoperatively.

Interventions

PROCEDUREloop ileostomi

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
MortalityDeath occurring during the first 90 daysDeath occurring during the first 90 postoperative days

Countries

Denmark

Contacts

Primary ContactMark Ellebæk, MD
markep01@gmail.com004540880511

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026