Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Qufora Irrisedo Cone System, Glycerol "OBA".
- Who it may be relevant to
- Registry conditions: Low Anterior Resection Syndrome, Rectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial
Overview
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).
Detailed description
Transanal irrigation (TAI) is used as a second-line treatment following unsuccessful personalised conservative treatment (PCT) of LARS. However, it is unknown if scheduled, initiated defecation with the aid of a glycerol suppository will have the same clinical effect as TAI. Thus, the aim of this study is to compare the effect of TAI with a glycerol suppository in patients suffering from major LARS.
The study is a multi-centre, randomised, controlled, 12 weeks, parallel-group trial comparing treatment with TAI to treatment with glycerol suppositories. Patients will be randomised - stratified by centre and neoadjuvant radiotherapy - in a 1:1 ratio to receive treatment with TAI or glycerol suppositories. Primary endpoint will be assessed by the end of week twelve.
Interventions
- Device Qufora Irrisedo Cone System
The system works by connecting a tube from a water bag to a cone. The cone is placed into the rectum and the prescribed water volume is pumped into the rectum. When the water has been installed the valve is closed and the cone removed. Residual water and stool will then flow into the toilet. - Drug Glycerol "OBA"
Rectal suppository. Stimulates the rectum and softens and loosens stool.
Primary outcome measures
- Bowel function, change in symptom 1 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score. [Time frame: 12 weeks.]
Secondary outcome measures (12)
- Bowel function, change in symptom 2 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score. [Time frame: 4, 8, and 12 weeks.]
- Change in activity score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score. [Time frame: 4, 8, and 12 weeks.]
- Change in well-being score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score. [Time frame: 4, 8, and 12 weeks.]
- Bowel function assessed using the Low Anterior Resection Syndrome (LARS) Score. [Time frame: 4, 8, and 12 weeks.]
- Bowel function assessed using the Memorial Sloan-Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI) Score. [Time frame: 4, 8, and 12 weeks.]
- Frequency of bowel movements, incontinence episodes (total, passive, and urge), urge episodes, soiling, and daily gas incontinence, incomplete emptying, and average urge time assessed using the Journl A/S application. [Time frame: Weeks 3-4, weeks 7-8, and weeks 11-12.]
- Fecal incontinence assessed using the St. Mark's Incontinence Score. [Time frame: 4, 8, and 12 weeks.]
- Female urinary function assessed using the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS). [Time frame: 12 weeks.]
- Male urinary function assessed using the International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS). [Time frame: 12 weeks.]
- Female sexual function assessed using The Rectal Cancer Female Sexuality Score. [Time frame: 12 weeks.]
- Male sexual function assessed using the 5-item International Index of Erectile Function (IIEF-5). [Time frame: 12 weeks.]
- Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-C30. [Time frame: 12 weeks.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Aarhus University Hospital, Department of Surgery — Aarhus
Identifiers
NCT: NCT04087421 · 676869