Pilot Study for Evaluation of the Need for Protective Ileostomy After Low Anterior Resection Due to Rectal Cancer

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-03-31

Brief Summary

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The purpose of this study is to determine whether protective ileostomy is required after low anterior resection due to rectal cancer

Detailed Description

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Since introduction of total mesorectal excision prognosis and quality of life of patients with rectal cancer of the middle or lower third of the rectum could be improved significantly. There is no valid data about the need of protective ileostomy in these patients. About 10% of the patients develop insufficiency of the anastomosis and might benefit from ileostomy whereas about 90% would not have required protective ileostomy retrospectively. Aim of the study is to show that protective ileostomy is not required if several criteria are fulfilled and early measures in case of clinical impairment are defined. Therefore eligibility criteria include safely performed stapler anastomosis with complete rings and control of impermeability by air insufflation. In the event of clinical impairment in the postoperative course CT scan with KM filling of the rectum to exclude insufficiency of the anastomosis will be performed. In case of insufficiency protective ileostomy will be created. 40 patients will be included.

Comparison: Patients with resectable rectal cancer of the middle or lower third will be intraoperatively randomized to either protective ileostomy or no ileostomy at all.

Conditions

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Rectal Cancer

Keywords

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protective ileostomy rectal cancer low anterior resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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protective ileostomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* radical resectable rectal cancer
* low sphincter-preserving resection of carcinomas of the lower and middle third
* preoperative normal continence
* preoperative normal sphincter function
* complete rings after stapler anastomosis
* impermeability of anastomosis for air
* written informed consent

Exclusion Criteria

* reduced cooperation or drug abuse
* pregnancy
* psychosis
* age under 18 years

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Department of General, Visceral and Transplantation Surgery

Principal Investigators

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Markus W Buchler, Chairman

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, University of Heidelberg, Medical School

Peter Kienle, Consultant

Role: STUDY_CHAIR

Department of Surgery, University of Heidelberg

Locations

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Clinical Study Center Surgery, Department of Surgery, University of Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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Ulrich AB, Seiler C, Rahbari N, Weitz J, Buchler MW. Diverting stoma after low anterior resection: more arguments in favor. Dis Colon Rectum. 2009 Mar;52(3):412-8. doi: 10.1007/DCR.0b013e318197e1b1.

Reference Type DERIVED

PMID: 19333040 (View on PubMed)

Other Identifiers

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433/2005

Identifier Type: -

Identifier Source: org_study_id