Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome

University of Aarhus

Status and phase: Enrolling; Phase 3

Conditions: Low Anterior Resection Syndrome; Rectal Cancer

Treatments: Drug: Glycerol "OBA"; Device: Qufora Irrisedo Cone System

Study type: Interventional

Funder types: Other

Identifiers

NCT04087421

676869

Details and patient eligibility

About

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).

Full 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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Transanal irrigation

Experimental group

Description:

Participants receiving TAI will irrigate once/day with stepwise volumes; 1. month 150 ml, 2. month 300 ml, and 3. month 500 ml.

Treatment:

Device: Qufora Irrisedo Cone System

Glycerol suppositories

Active Comparator group

Description:

Participants treated with glycerol suppositories will administer one glycerol suppository once/day.

Treatment:

Drug: Glycerol "OBA"