Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Qufora Irrisedo Cone System, Glycerol "OBA".
- Кому может быть актуально
- Состояния в реестре: Low Anterior Resection Syndrome, Rectal Cancer. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial
Обзор
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).
Подробное описание
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.
Вмешательства
- Устройство Qufora Irrisedo Cone System
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. - Препарат Glycerol "OBA"
Rectal suppository. Stimulates the rectum and softens and loosens stool.
Первичные конечные точки
- Bowel function, change in symptom 1 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score. [Срок оценки: 12 weeks.]
Вторичные конечные точки (12)
- Bowel function, change in symptom 2 score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score. [Срок оценки: 4, 8, and 12 weeks.]
- Change in activity score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score. [Срок оценки: 4, 8, and 12 weeks.]
- Change in well-being score assessed using the Measure Yourself Medical Outcome Profile (MYMOP2) Score. [Срок оценки: 4, 8, and 12 weeks.]
- Bowel function assessed using the Low Anterior Resection Syndrome (LARS) Score. [Срок оценки: 4, 8, and 12 weeks.]
- Bowel function assessed using the Memorial Sloan-Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI) Score. [Срок оценки: 4, 8, and 12 weeks.]
- 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. [Срок оценки: Weeks 3-4, weeks 7-8, and weeks 11-12.]
- Fecal incontinence assessed using the St. Mark's Incontinence Score. [Срок оценки: 4, 8, and 12 weeks.]
- Female urinary function assessed using the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS). [Срок оценки: 12 weeks.]
- Male urinary function assessed using the International Consultation on Incontinence Questionnaire Male Lower Urinary Tract Symptoms (ICIQ-MLUTS). [Срок оценки: 12 weeks.]
- Female sexual function assessed using The Rectal Cancer Female Sexuality Score. [Срок оценки: 12 weeks.]
- Male sexual function assessed using the 5-item International Index of Erectile Function (IIEF-5). [Срок оценки: 12 weeks.]
- Quality of life assessed using the EORTC Quality of Life questionnaire (QLQ)-C30. [Срок оценки: 12 weeks.]
Критерии участия
Критерии включения
- 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).
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Дания · 1 центр
- Aarhus University Hospital, Department of Surgery — Aarhus
Идентификаторы
NCT: NCT04087421 · 676869