Clinical trial · Interventional
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial
NCT04087421CI-TRIAL-00066108recruitingPhase 3ClinicalTrials.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)
The study is a multicentre randomized controlled trial with the objective to compare the effect of transanal irrigation with glycerol suppositories in patients suffering from major Low Anterior Resection Syndrome (LARS).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glycerol "OBA" | Drug | — | UNRESOLVED |
| Qufora Irrisedo Cone System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transanal irrigation
- description
- Participants receiving TAI will irrigate once/day with stepwise volumes; 1. month 150 ml, 2. month 300 ml, and 3. month 500 ml.
- interventionNames
- Device: Qufora Irrisedo Cone System
- type
- ACTIVE_COMPARATOR
- label
- Glycerol suppositories
- description
- Participants treated with glycerol suppositories will administer one glycerol suppository once/day.
- interventionNames
- Drug: Glycerol "OBA"
Primary outcomes (1)
- measure
- Bowel function, change in symptom 1 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients electively treated for rectal cancer with a low anterior resection. * Unsuccessful PCT after at least 4 weeks of treatment for LARS (LARS score \>29 at evaluation). * At least 3 months after surgery (including reversal of a temporary loop-ileostomy). * Age \>= 18 years * Ability to understand written and spoken language actual for the including site (due to questionnaire validity). Exclusion Criteria: * Former use of TAI * Prior systematic use of rectal emptying aids * Anastomotic stenosis * History of anastomotic leakage * Current metastatic disease or local recurrence * Ongoing oncological treatment * Postoperative radiotherapy for rectal cancer * Previous or current cancer in other pelvic organs than the rectum * Underlying diarrhoeal disease * Inflammatory bowel disease * Dementia * Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant neurologic disease assessed to be a contributory cause to LARS symptoms. * Inability of patient to use TAI * Inability and unwillingness to give informed consent * Pregnancy or intention to become pregnant during the trial period
References
Publications (0)
Data not yet available
No reference posted for this study.