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Defunctioning Left-sided Colostomy in Low Anterior Resection for Rectal Cancer

NCT ID: NCT06149741

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2025-12-31

Brief Summary

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This is prospective, multi centre study evaluating a novel type of defunctioning loop stoma after low anterior resection for rectal cancer. Patients will be operated with a complete splenic flexure mobilisation and total mesorectal excision. An anastomosis will be fashioned at the pelvic floor. This will leave a redundant colon which will be brought up and matured in the left iliac fossa. Patient bowel function and quality of life will be monitored at baseline and at one year postoperatively, when the stoma will typically have been reversed. Dehydration and kidney injury are expected to become infrequent in comparison with the main alternative loop ileostomy. About 20 patients will be included in this pilot study.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Left-sided loop colostomy

Left-sided loop colostomy matured in left iliac fossa after complete splenic flexure mobilisation, mesorectal excision and anastomosis

Group Type EXPERIMENTAL

Defunctioning left-sided loop colostomy

Intervention Type PROCEDURE

Descending or left transverse double-barrelled loop colostomy in left iliac fossa after complete splenic flexure mobilisation, mesorectal excision, and anastomosis.

Interventions

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Defunctioning left-sided loop colostomy

Descending or left transverse double-barrelled loop colostomy in left iliac fossa after complete splenic flexure mobilisation, mesorectal excision, and anastomosis.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Capacity for informed consent
* Planned defunctioning stoma
* Planned mesorectal excision with anastomosis for rectal cancer

Exclusion Criteria

* Manifest atherosclerotic disease (peripheral vascular disease, previous myocardial infarction, angina, etc)
* Previous oncological colonic resection
* Defunctioning stoma in situ
* Intraoperative event leading to bowel resection and subsequent inability to bring out left-sided colostomy without tension on the anastomosis
* Intraoperative circumstances as judged by the operating surgeon leading to unacceptable risks due to loop colostomy placement (abdominal wall size, short mesentery, other preconditions)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunderby Hospital

OTHER

Sponsor Role collaborator

Östersund Hospital

UNKNOWN

Sponsor Role collaborator

Sundsvall Hospital

OTHER

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Umeå University Hospital

Umeå, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Martin Rutegård, MD, PhD

Role: CONTACT

Phone: +46907850000

Email: [email protected]

Facility Contacts

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Martin Rutegård, MD, PhD

Role: primary

Other Identifiers

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UmU-STOMALEFT

Identifier Type: -

Identifier Source: org_study_id