Rectal Cancer Trial On Defunctioning Stoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00636948

Acronym

RECTODES

Enrollment

234

Registered

2008-03-17

Start date

1999-12-31

Completion date

Unknown

Last updated

2008-03-17

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

Conditions

Rectal Cancer

Keywords

Rectal cancer surgery, Symptomatic anastomotic leakage, Defunctioning stoma, TME surgery

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Reoperation within 30 days of initial surgery.	30 days

Countries

Sweden

Outcome results