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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00457327
Enrollment
40
Registered
2007-04-06
Start date
2006-07-31
Completion date
2007-03-31
Last updated
2008-06-05

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

Conditions

Rectal Cancer

Keywords

protective ileostomy, rectal cancer, low anterior resection

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.

Interventions

Sponsors

Heidelberg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Morbidity and mortality until day 30 postoperative

Secondary

MeasureTime frame
Quality of life
Ranking of factors influencing quality of life

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026