Clinical trial · Observational
Quality of Life in Patients With Rectal Cancer Receiving Total Mesorectal Excision With or Without Stoma
Quality of Life in Patients With Rectal Cancer Receiving Neoadjuvant Chemotherapy, Total Mesorectal Excision With or Without Stoma and Adjuvant Chemotherapy: a Prospective, Single-centre Pilot-study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): insufficient recruitment
Summary
Brief summary (as posted)
The goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with total mesorectal excision (TME) and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Faecal Incontinence Score | Behavioral | — | UNRESOLVED |
| Quality of Life Questionnaire | Behavioral | — | UNRESOLVED |
| Quality of Life Questionnaire for gastrointestinal tract | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- With protective stoma
- description
- Patients in which intraoperatively the decision was made to add a protective stoma (following a risk algorithm) to total mesorectal excision. In patients quality of life, the Gastrointestinal Quality of Life Index (GIQLI) questionnaire, Quality of Life Questionnaire for gastrointestinal tract and Faecal Incontinence Score will be applied.
- interventionNames
- Behavioral: Quality of Life Questionnaire for gastrointestinal tract
- Behavioral: Quality of Life Questionnaire
- Behavioral: Faecal Incontinence Score
- label
- No stoma
- description
- Patients in which intraoperatively the decision was made to refrain from adding a protective stoma (following a risk algorithm) to total mesorectal excision. In patients quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index), Quality of Life Questionnaire for gastrointestinal tract and Faecal Incontinence Score will be applied.
- interventionNames
- Behavioral: Quality of Life Questionnaire for gastrointestinal tract
- Behavioral: Quality of Life Questionnaire
- Behavioral: Faecal Incontinence Score
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age older than 18, * low anterior resection and TME due to rectum carcinoma after standardized neoadjuvant combined chemo- and radiotherapy and receiving adjuvant postoperative chemotherapy, * German speaking patient who is capable to fill in the questionnaire, * signed informed consent Exclusion Criteria: * age younger than 18, * preoperative stoma, * not German speaking * inability to fill in the questionnaire, * no standardized chemo- and radiotherapy
References
Publications (0)
Data not yet available