Early Reversal of Defunctioning Stoma Trial

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00640913

Acronym

ELSOR

Enrollment

Registered

2008-03-21

Start date

2008-02-29

Completion date

2009-11-30

Last updated

2008-03-21

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

Conditions

Rectal Cancer

Keywords

Defunctioning stoma, Low anterior resection, TME surgery, Early stoma reversal

Brief summary

In this trial will be investigated if a defunctioning loop stoma used in low anterior resection of the rectum for cancer can be reversed after 14 days instead of 3-12 months which is present clinical practise.

Detailed description

Patients undergoing low anterior resection of the the rectum for adenocarcinom (total mesorectal excision; TME) with a defunctioning loop stoma are assessed preoperatively and for 6 days postoperatively according to a trial protocol including daily clinical, physiological, and serological variables, and a rectal contrast study on day 6. If inclusion criteria are fulfilled, a decision is taken on day 7 to schedule reversal of the defunctioning loop stoma on postoperative day 14. This trial is considered a hypothesis generating pilot study of feasibility type and is no power calculation. The present trial will include 20 consecutive patients who accept participation.

Interventions

PROCEDUREReversal of defunctioning stoma

Reversal of defunctioning stoma

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Written consent and fulfilled inclusion criteria preoperatively and during postoperative day 1-6.

Exclusion criteria

* Written consent and/or inclusion criteria not fulfilled preoperatively and during postoperative day 1-6.

Design outcomes

Primary

Measure	Time frame
Reversal of defunctioning loop stoma on postoperative day 14 following low anterior resection of the rectum for cancer with or without preoperative adjuvant treatment	Preoperatively, postoperative day 7, postoperative day 30 and at 6 months postoperatively

Secondary

Measure	Time frame
Postoperative 30 day morbidity. Postoperative ano-rectal function at 1 and 6 months.	Postoperatively at 1 and 6 months.

Countries

Sweden

Contacts

Primary ContactPeter Matthiessen, MD, PhD

peter.matthiessen@orebroll.se0046 19 602 20 76

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026