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Completed

NCT Number: NCT04586634

Randomized Clinical Trial on Transanal Irrigation

Objective The primary objective is to demonstrate superiority of the Peristeen cone catheter compared to standard of care.

The secondary objective is to investigate quality of life and different benefits and aspects of treatment and satisfaction with the Peristeen cone catheter.

Design of the investigation This is a randomised, open-label, parallel investigation comparing the Peristeen cone catheter with standard of care in subjects with major LARS (LARS score ≥ 30). Each subject will be enrolled for a study duration of 12 weeks. Subjects will be randomized to the treatments stratified by neo-adjuvant radiotherapy.

The comparator in this study will be current standard of care for patients with LARS which is conservative bowel management. This is defined as: Supportive therapy according to the individual treatment protocols available at each participating site.

Primary endpoint and secondary endpoints

Primary endpoint:

• LARS score, obtained from the LARS score questionnaire*

Secondary endpoints:

* Number of subjects with Major LARS* * FIQL Score - scale 1, Modified American Society for Colorectal Surgeons Questionnaire* * FIQL Score - scale 2, Modified American Society for Colorectal Surgeons Questionnaire* * FIQL Score - scale 3, Modified American Society for Colorectal Surgeons Questionnaire* * FIQL Score - scale 4, Modified American Society for Colorectal Surgeons Questionnaire* * EQ-5D-5L - utility score* * EQ-5D-5L - VAS score (scale 0-10 cm)* * Satisfaction with treatment (scale 0-10 cm)* * Number of adverse events* *All endpoints are measured per subject at study completion

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Key information

Conditions

Low Anterior Resection Syndrome Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coloplast A/S

Humlebæk, 3050, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be at least 18 years of age and have full legal Capacity
  • Have given written informed consent
  • Be mental and physical capable to perform transanal irrigation with cone catheter
  • Have a LARS score ≥ 30 after rectal resection
  • Be treated according to individual treatment protocol for conservatory bowel management at participating site
  • Have proof of complete healing of the anastomosis by endoscopy or radiology before stoma closure
  • At least 3-months from last surgery in colorectum
  • Be evaluated to be suitable for transanal Irrigation procedure with a cone catheter by endoscopy, defecography or comparable procedure

Exclusion criteria

  • Active/recurrent colorectal cancer
  • Leaking anastomosis
  • Known anal or colorectal stenosis
  • Within 4 weeks of endoscopic polypectomy
  • Ischaemic colitis
  • Acute inflammatory bowel disease
  • Acute diverticulitis
  • Current or planned pregnancy

Treatment and study plan

Peristeen cone catheter

Device

The active intervention is the Peristeen cone catheter device. The comparator in this investigation is current standard of care for patients with LARS which is conservative bowel management.

Primary outcomes

  1. LARS Score

    Time frame: Total score measured per subject at study completion after 12 weeks

    Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS.

Secondary outcomes

  1. Number of Subjects With Major LARS

    Time frame: 12 weeks

    Obtained from the LARS score questionnaire on a scale from 0-42 in total score. Subscores are summed to get the total score. With 0 indicating lowest score and 42 highest score. 0-20 indicate No LARS, 21-29 minor LARS, 30-42 Major LARS.

  2. FIQL Score - Scale 1 Lifestyle, Modified American Society for Colorectal Surgeons Questionnaire

    Time frame: 12 weeks

    The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions).

    Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).

  3. FIQL Score - Scale 2 Coping/Behavior, Modified American Society for Colorectal Surgeons Questionnaire

    Time frame: 12 weeks

    The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions).

    Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).

  4. FIQL Score - Scale 3 Depression/Self-perception, Modified American Society for Colorectal Surgeons Questionnaire

    Time frame: 12 weeks

    The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions).

    Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).

  5. FIQL Score - Scale 4 Embarrassment , Modified American Society For Colorectal Surgeons Questionnaire

    Time frame: 12 weeks

    The FIQL scale was thus interpreted for four scales exploring different aspects of the patient's quality-of-life. the Fecal Incontinence Quality of Life Scale (FIQL) contains 29 questions, across 4 domains, lifestyle (10 questions), Coping/Behavior (9 questions), Depression/Self Perception (7 questions), Embarrassment (3 questions).

    Items were scored 1 (least satisfactory quality-of-life) to 4 (most satisfactory quality-of-life) Results are reported as a Scale score which is the average (mean) response to all items in the scale (e.g., add the responses to all questions in a scale together and then divide by the number of items in the scale).

  6. EQ-5D-5L - Utility Score

    Time frame: 12 weeks

    Each of the five dimensions comprising the EQ-5D descriptive system (mobility, self-care, usual activates, pain/discomfort, anxiety/depression) was divided into five levels:

    • no problem
    • slight problems
    • moderate problems
    • severe problems
    • unable to/extreme problems A unique health state was defined by combining one level from each of the five dimensions. i.e. state 12345 each state referred to by a 5-digit code was mapped into a utility score.

    Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. EQ-5D-5L health states are converted into a single index 'utility' score using a scoring algorithm based on public preferences. Potential values from this algorithm can range from minus scores up to 1, in this case -0.525 to 1.

  7. EQ-5D-5L - VAS Score

    Time frame: 12 weeks

    The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. The VAS scale is from 0 to 100 with 0 indicating worst health and 100 best health possible.

  8. Satisfaction With Treatment

    Time frame: 12 weeks

    Satisfaction with current bowel management treatment on a scale from 0 (total dissatisfaction) to 10 (perfect satisfaction)" rated on a VAS scale from 0 to 10 cm.

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Collaborators

  • MedPass International

Registry information

Official study title

Randomized Clinical Trial Assessing the Effect of Transanal Irrigation With Cone Catheter Versus Conservative Bowel Management on Symptoms of Low Anterior Resection Syndrome After Rectal Resection

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2020
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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