Clinical trial NCT00457327: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: protective ileostomy
rectal cancer
low anterior resection
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2007-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Morbidity and mortality until day 30 postoperative
Secondary outcomes:
measure: Quality of life
measure: Ranking of factors influencing quality of life
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Clinical Study Center Surgery, Department of Surgery, University of Heidelberg
Study officials:
affiliation: Department of Surgery, University of Heidelberg, Medical School
name: Markus W Buchler, Chairman
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, University of Heidelberg
name: Peter Kienle, Consultant
role: STUDY_CHAIR
References:
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.