Rectal Cancer Trial On Defunctioning Stoma

The hypothesis of the present trial was that the use of a defunctioning loop stoma reduces the rate of symptomatic anastomotic leakage from 15% to 7.5% after low anterior resection of the rectum for cancer.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Surgery, Linköping University Hospital

Linköping, 581 85, Sweden

About this study

The assumption that a defunctioning loop stoma reduces symptomatic anastomotic leakage from 15% to 7.5%, with a level of statistical significance of 5% and a statistical power of 80%, requires randomization of 220 patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Absence of intraoperative adverse events according to the study protocol and the operating surgeon.

Exclusion criteria

Presence of intraoperative adverse events according to the study protocol and the operating surgeon.

Treatment and study plan

Primary outcomes

Symptomatic anastomotic leakage following low anterior resection of the rectum for cancer with and without a defunctioning stoma. Anorectal function after one and five years without defunctioning stoma.

Time frame: 30 days, one year and five years.

Secondary outcomes

Reoperation within 30 days of initial surgery.

Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Rectal Cancer Trial on Defunctioning Stoma Study Group

Other

Registry information

Acronym: RECTODES

Important dates

Study start: 1999
Primary completion: 2005
First posted: Mar 17, 2008
Registry last updated: Mar 17, 2008

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.

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Completed