What is this study trying to find out about Low Anterior Resection Syndrome?

This study is investigating whether low volume Transanal Irrigation using the Qufora IrriSedo MiniGo device combined with standard conservative care improves symptoms of Low Anterior Resection Syndrome compared to conservative care alone. It aims to better understand treatment options for patients who have undergone surgery for rectal cancer. The research is sponsored by Qufora A/S.

Who may be eligible for this Low Anterior Resection Syndrome clinical trial?

Adults aged 18 years or older who have had rectal cancer treated with low anterior resection and are 3 to 18 months post-surgery or stoma reversal may be eligible. They must have a LARS score of 25 or higher, be physically and mentally able to manage the MiniGo device, and be affiliated with a health social security system. Please review eligibility criteria for more details.

Is there any cost to participate in this Low Anterior Resection Syndrome clinical trial?

Study-related care, including the study procedure and all trial visits, is provided at no cost. However, personal travel expenses and other related costs may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Age: 18Years +

All Genders

ID06923150

Randomized Study Comparing Low Volume Transanal Irrigation by Qufora48 IrriSedo MiniGo with Conservative Treatment in Adults with Low Anterior Resection Syndrome

Led by Qufora A/S · Updated on 2025-04-11

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of low volume Transanal Irrigation TAI using the Qufora IrriSedo MiniGo device combined with standard conservative treatments compared to conservative treatment alone for patients with Low Anterior Resection Syndrome LARS. This condition affects individuals who have undergone surgery for rectal cancer. The study aims to assess improvements in clinical symptoms of LARS over a three-month period. Participants are divided into two groups one receiving low volume TAI with the MiniGo device plus standard conservative care, which includes dietary management, counseling, and prescribed medications excluding suppositories and physiotherapy and another group receiving only the standard conservative treatments. The study includes follow-ups at 6 weeks, 3 months, and up to 12 months to monitor various outcomes. During the study, participants will be regularly assessed using the LARS score to measure symptom changes, quality of life questionnaires EORTC QLQ-C30 and QLQ-CR29, incontinence scores, patient satisfaction, treatment compliance, bowel management time, and healthcare resource usage. Data will be collected at multiple intervals including 6 weeks, 3 months, 6 months, 9 months, and 12 months to thoroughly evaluate the treatment impact and patient preferences.

CONDITIONS

Brief Title

A Randomised Clinical Investigation to Assess Efficacy of Low Volume Transanal Irrigation by Qufora® IrriSedo MiniGo Versus Conservative Treatment for Low Anterior Resection Syndrome Patients

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 years or older
Patients electively treated for rectal cancer with a low anterior resection
Between 3 and 18 months after colorectal surgery or stoma reversal
LARS score of 25 or higher with at least one symptom causing a consequence
Previous conservative treatments started for at least one month
Able mentally and physically to handle the MiniGo device independently
No signs of leakage or clinically relevant stenosis at the anastomosis
Affiliated with a health social security system

You will not qualify if you...

Contraindication to use Transanal Irrigation (TAI)
Previous use of TAI after colorectal surgery
Clinically relevant stenosis
Current metastatic disease or local recurrence
Ongoing chemotherapy
Postoperative radiotherapy for rectal cancer
History of diarrheal disease
Inflammatory bowel disease
Dementia
Spinal cord injury, multiple sclerosis, Parkinson's disease, or other significant contributing diseases
Cancer recurrence
Life expectancy less than one year
Participation in another clinical trial for LARS treatment
Ongoing pelvic floor rehabilitation or biofeedback
Pregnancy or planning pregnancy during the trial
Unable or unwilling to give informed consent

Research Team

Rogini Balachandran

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