Defunctioning Stoma and Postoperative Morbidity

Completed

• Conditions: Loopileostomy; Fast Track Program,(Enhanced Recovery After Surgery (ERAS))

• Registration Number: NCT01789515
• Lead Sponsor: Karolinska Institutet

Brief Summary

In an attempt to reduce the risk for anastomotic leakage after low anterior resection it is common to create a diverting stoma at the same procedure. Several studies have shown that ERAS (Enhanced Recovery After Surgery)application reduces the risk of surgical stress and postoperative complications after major colorectal surgery. The aim of this study is to evaluate wether a diverting stoma, after low anterior resection for rectal cancer, affects postoperative morbidity in patients treated within an ERAS program.

Detailed Description

See above.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-09-28
• Study First Submitted QC: 2013-02-08
• Study First Posted: 2013-02-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-11
• Last Update Posted: 2014-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

Inclusion Criteria

• all patients operated with low anterior resection for rectal cancer at Ersta Hospital between 2002 and 2011 registrated in ERAS database

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical anastomotic leakage	0 to 9 years after surgery	Evaluate if a diverting stoma after low anterior resection affects postoperative Morbidity in patients treaated within an ERAS program

Secondary Outcome Measures

Name	Time	Method
Permanent stoma	0 to 9 years after surgery

Trial Locations

Locations (1)

Ersta Hospital; 🇸🇪 Stockholm, Sweden