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OpenTrials
Completed

NCT Number: NCT01789515

Defunctioning Stoma and Postoperative Morbidity

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ersta Hospital

Stockholm, 116 91, Sweden

About this study

See above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clinical anastomotic leakage

    Time frame: 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 outcomes

  1. Permanent stoma

    Time frame: 0 to 9 years after surgery

Other outcomes

  1. Total days of hospital stay

    Time frame: 0-9 years after surgery

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Ersta Hospital, Sweden

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 12, 2013
Registry last updated
Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.