Clinical trial · Interventional
Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction
Assessment of Symptoms and Their Consequences on Patients Quality of Life After Coloanal Continuity Reconstruction Following a Proctectomy for Rectal Cancer
- 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)
This study is a prospective, monocentric study whose aim is to assess the quality of life for patients who underwent a coloanal continuity reconstruction and to understand the functional issues they encounter. This will potentially provide predictive factors identification of bad functional outcomes allowing to guide future decisions. Also, it will allow patients to have a reinforced follow-up during the year after the reconstruction.
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 |
|---|---|---|---|
| Pre- and post-operative consultation | Procedure | — | UNRESOLVED |
| Questionnaires | Procedure | — | UNRESOLVED |
| Stomatherapy consultation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study process
- description
- Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires
- interventionNames
- Procedure: Pre- and post-operative consultation
- Procedure: Stomatherapy consultation
- Procedure: Questionnaires
Primary outcomes (1)
- measure
- Quality of life 1 year after the second intervention, using LARS score
- timeFrame
- from baseline to 1 year after the second intervention
- description
- Obtain an objective assessment of symptoms intensity (using the LARS score)for patients who received a proctectomy for rectal cancer ("1st intervention") following by a coloanal continuity reconstruction ("2nd intervention")
Secondary outcomes (9)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 18 to 70 years old * Patients who are going to undergo a proctectomy for a rectal cancer (situated at a distance equal or lower to 15 cm from the anoderm) following by a coloanal continuity reconstruction (using direct, latero-terminal or colonic J-pouch anastomosis) * Already underwent or not a neoadjuvant radio-chemotherapy * Affiliation to the National Social Security System * With informed and signed consent Exclusion Criteria: * Unwilling patients * Patient deprived of their liberty or under guardianship or tutorship. * Abdominal perineal amputation * No stoma placement planned * Tumor more than 15 cm from the anal margin
References
Publications (0)
Data not yet available