Defunctioning Stoma and Postoperative Morbidity

Fast Track Program,(Enhanced Recovery After Surgery (ERAS)) Clinical Trial

Official title:

Diverting Stoma and Postoperative Morbidity After Low Anterior Resection for Rectal Cancer Within an Enhanced Recovery After Surgery,ERAS, Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789515
• Other study ID #: 2012/538-31/1
• Status: Completed
• Phase: N/A
• First received: September 28, 2012
• Last updated: March 11, 2014
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Observational

Clinical Trial 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.

Description:

See above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Sweden	Ersta Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Ersta Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total days of hospital stay		0-9 years after surgery	Yes
Primary	Clinical anastomotic leakage	Evaluate if a diverting stoma after low anterior resection affects postoperative Morbidity in patients treaated within an ERAS program	0 to 9 years after surgery	Yes
Secondary	Permanent stoma		0 to 9 years after surgery	Yes