Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Former use of TAI
Prior systematic use of rectal emptying aids
Anastomotic stenosis
History of anastomotic leakage
Trial design
Design model
Parallel
Treatments tested in this trial
Qufora Irrisedo Cone System
DeviceThe 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.
Glycerol "OBA"
DrugRectal suppository. Stimulates the rectum and softens and loosens stool.
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: Transanal irrigationExperimental treatment 1 intervention
Group B: Glycerol suppositoriesActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Bowel function, change in symptom 1 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.
MYMOP2 is a validated problem-specific, patient-generated questionnaire. Patients are asked to specify one or two symptoms that concern them the most. Subsequently they evaluate the severity on a 7-point Likert scale. The second part of the questionnaire uses the same scale to assess whether the symptom limits or prevent any daily activity, and also to rate general well-being. Follow-up questionnaires address the original issues completed in the initial form. Symptom 1, symptom 2, activity, and wellbeing each have a separate score between 0 and 6 with 0 indicating "as good as it could be" and 6 "as bad as it could be". An overall score is calculated by taking the average of item scores.
Time frame
12 weeks.Secondary outcomes
1
Bowel function, change in symptom 2 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.
MYMOP2 is a validated problem-specific, patient-generated questionnaire. Patients are asked to specify one or two symptoms that concern them the most. Subsequently they evaluate the severity on a 7-point Likert scale. The second part of the questionnaire uses the same scale to assess whether the symptom limits or prevent any daily activity, and also to rate general well-being. Follow-up questionnaires address the original issues completed in the initial form. Symptom 1, symptom 2, activity, and wellbeing each have a separate score between 0 and 6 with 0 indicating "as good as it could be" and 6 "as bad as it could be". An overall score is calculated by taking the average of item scores.
Time frame
4, 8, and 12 weeks.2
Change in activity score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.
MYMOP2 is a validated problem-specific, patient-generated questionnaire. Patients are asked to specify one or two symptoms that concern them the most. Subsequently they evaluate the severity on a 7-point Likert scale. The second part of the questionnaire uses the same scale to assess whether the symptom limits or prevent any daily activity, and also to rate general well-being. Follow-up questionnaires address the original issues completed in the initial form. Symptom 1, symptom 2, activity, and wellbeing each have a separate score between 0 and 6 with 0 indicating "as good as it could be" and 6 "as bad as it could be". An overall score is calculated by taking the average of item scores.
Time frame
4, 8, and 12 weeks.3
Change in well-being score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.
MYMOP2 is a validated problem-specific, patient-generated questionnaire. Patients are asked to specify one or two symptoms that concern them the most. Subsequently they evaluate the severity on a 7-point Likert scale. The second part of the questionnaire uses the same scale to assess whether the symptom limits or prevent any daily activity, and also to rate general well-being. Follow-up questionnaires address the original issues completed in the initial form. Symptom 1, symptom 2, activity, and wellbeing each have a separate score between 0 and 6 with 0 indicating "as good as it could be" and 6 "as bad as it could be". An overall score is calculated by taking the average of item scores.
Time frame
4, 8, and 12 weeks.4
Bowel function assessed using the Low Anterior Resection Syndrome (LARS) Score.
The LARS score is a validated questionnaire for evaluation of bowel function after sphincter-preserving surgery. It covers five LARS symptoms including: incontinence for flatus, incontinence for liquid stools, frequency (number of daily bowel movements), clustering, and urgency. The scores from each five answers are added to one final score. The score ranges from 0-42 with 0 indicating the best score and 42 the worst. Based on the score patients are stratified into: 0-20: No LARS, 21-29: Minor LARS, 30-42: Major LARS.
Time frame
4, 8, and 12 weeks.Sponsors and contacts
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Source ClinicalTrials.gov