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

NCT04087421 | Recruiting Phase 3 DMC

• 1 other identifier: 676869
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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).

Conditions

Low Anterior Resection Syndrome; Rectal Cancer

Keywords

Low Anterior Resection Syndrome; Transanal irrigation; Glycerol suppositories

Outcome Measures

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.

  12 weeks.

Secondary Outcomes (16)

• Bowel function, change in symptom 2 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.

  4, 8, and 12 weeks.

• Change in activity score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.

  4, 8, and 12 weeks.

• Change in well-being score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score.

  4, 8, and 12 weeks.

• Bowel function assessed using the Low Anterior Resection Syndrome (LARS) Score.

  4, 8, and 12 weeks.

• Bowel function assessed using the Memorial Sloan-Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI) Score.

  4, 8, and 12 weeks.

Study Arms (2)

Transanal irrigation

EXPERIMENTAL

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

Device: Qufora Irrisedo Cone System

Glycerol suppositories

ACTIVE COMPARATOR

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

Drug: Glycerol "OBA"

Interventions

Qufora Irrisedo Cone System DEVICE

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.

Transanal irrigation

Glycerol "OBA" DRUG

Rectal suppository. Stimulates the rectum and softens and loosens stool.

Glycerol suppositories

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital, Department of Surgery

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Peter Christensen

  Research Unit, Dept. of Surgery, Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mira Mekhael, M.D.

CONTACT

+4526213506; mirmek@rm.dk

Peter Christensen, Professor

CONTACT

petchris@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: September 12, 2019
• Study Start: September 17, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)