Clinical trial · Interventional
Psychological and Enterostomal Therapy Care
Impact of Psychological and Enterostomal Therapy Care for Patient Undergoing Rectal Cancer Resection With a Temporary Stoma. Monocentric Randomized Study
NCT01403883CI-TRIAL-00016636PROSPERunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In case of rectal cancer surgery, temporary stoma is recommended to decrease the risk of postoperative anastomotic leakage. The aim of the study was to assess the benefit of an optimal care, i.e., both psychological and enterostomal therapy care.
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 |
|---|---|---|---|
| Cancer of Rectum | Malignant Rectal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Optimal care (Psychological and enterostomal therapy clinics) | Behavioral | — | UNRESOLVED |
| Standard Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard care
- description
- standard care of patient with psychological and enterostomal therapy clinic if necessary
- interventionNames
- Behavioral: Standard Care
- type
- EXPERIMENTAL
- label
- Optimal care
- description
- Optimal care of patient with systematic and repeated psychological and enterostomal therapy follow up
- interventionNames
- Behavioral: Optimal care (Psychological and enterostomal therapy clinics)
Primary outcomes (2)
- measure
- Evolution of Global Quality of life (SF36)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 y * Rectal adenocarcinoma (tumor height \< 15 cm from the anal verge) with or without pre operative radiochemotherapy. * Open or laparoscopic rectal excision with partial or total meso rectal excision with sphincter preservation by colo rectal or colo anal anastomosis. * Temporary stoma. * Patient consent * Patient with national health affiliation Exclusion Criteria: * Stage IV disease with synchronous hepatic or pulmonary metastases * Colonic cancer \> 16 cm * Associated surgical procedure (Hepatic resection, small bowel resection subtotal colectomy) * Abdominal perineal resection * Associated comorbidity * Emergency surgery * Psychological care refusal
References
Publications (0)
Data not yet available
No reference posted for this study.