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

Primary Purpose

Rectal Cancer

Status

Terminated

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

protective ileostomy

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring protective ileostomy, rectal cancer, low anterior resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Morbidity and mortality until day 30 postoperative

Secondary Outcome Measures

Quality of life

Ranking of factors influencing quality of life

Full Information

NCT ID

NCT00457327

First Posted

April 4, 2007

Last Updated

June 4, 2008

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT00457327

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Terminated

Why Stopped

RCT with same hypothesis ended and showed a superiority for protective ileostomy after lower anterior rectum resection.

Study Start Date

July 2006 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Heidelberg University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer

Keywords

protective ileostomy, rectal cancer, low anterior resection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

protective ileostomy

Primary Outcome Measure Information:

Title

Morbidity and mortality until day 30 postoperative

Secondary Outcome Measure Information:

Title

Quality of life

Title

Ranking of factors influencing quality of life

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Markus W Buchler, Chairman

Organizational Affiliation

Department of Surgery, University of Heidelberg, Medical School

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Peter Kienle, Consultant

Organizational Affiliation

Department of Surgery, University of Heidelberg

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

19333040

Citation

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.

Results Reference

derived

Links:

URL

http://www.sdgc.de/

Description

Study Center of the German Surgical Society

Learn more about this trial

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

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