Clinical trial NCT04087421: Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
Official title: Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Low Anterior Resection Syndrome
Rectal Cancer
Keywords: Low Anterior Resection Syndrome
Transanal irrigation
Glycerol suppositories
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Bowel function, change in symptom 1 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.
timeFrame: 12 weeks.
Secondary outcomes:
measure: Bowel function, change in symptom 2 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.
timeFrame: 4, 8, and 12 weeks.
measure: Change in activity score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.
timeFrame: 4, 8, and 12 weeks.
measure: Change in well-being score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.
timeFrame: 4, 8, and 12 weeks.
measure: Bowel function assessed using the Low Anterior Resection Syndrome (LARS) Score.
timeFrame: 4, 8, and 12 weeks.
measure: Bowel function assessed using the Memorial Sloan-Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI) Score.
timeFrame: 4, 8, and 12 weeks.
measure: 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.
timeFrame: Weeks 3-4, weeks 7-8, and weeks 11-12.
measure: Fecal incontinence assessed using the St. Mark's Incontinence Score.
timeFrame: 4, 8, and 12 weeks.
measure: Female urinary function assessed using the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS).
timeFrame: 12 weeks.
measure: Male urinary function assessed using the International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS).
timeFrame: 12 weeks.
measure: Female sexual function assessed using The Rectal Cancer Female Sexuality Score.
timeFrame: 12 weeks.
measure: Male sexual function assessed using the 5-item International Index of Erectile Function (IIEF-5).
timeFrame: 12 weeks.
measure: Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-C30.
timeFrame: 12 weeks.
measure: Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-CR29.
timeFrame: 12 weeks.
measure: Impact on quality of life and activities assessed using the Journl A/S application.
timeFrame: Weeks 3-4, weeks 7-8, and weeks 11-12.
measure: Quality of life and Health economics assessed using the European Quality of Life-5 Dimensions 5-level version questionnaire (EQ-5D-5L).
timeFrame: 12 weeks.
measure: Health economics assessed using the ICEpop CAPability measure for Adults (ICECAP-A).
timeFrame: 12 weeks.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department of Surgery
Study officials:
affiliation: Research Unit, Dept. of Surgery, Aarhus University Hospital, Denmark
name: Peter Christensen
role: PRINCIPAL_INVESTIGATOR
References: