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

Обзор

The purpose of this post-market clinical follow up study is to assess the efficacy on clinical symptoms of LARS of low volume Transanal Irrigation by MiniGo in conjunction with conservative treatment versus conservative treatment at 3 months.

Первичные конечные точки

• LARS score difference [Срок оценки: 3-month follow-up]

Вторичные конечные точки (12)

• efficacy on clinical symptom of transanal Irrigation by MiniGo in improving the LARS score at 6 weeks [Срок оценки: 6-week follow-up]
• QoL with the EORTC QLQ-C30 EORTC QLQ-CR29 [Срок оценки: 3-month follow- up]
• change (reduction) of symptoms and consequences [Срок оценки: 6 weeks and 12 weeks]
• patient satisfaction [Срок оценки: 6 weeks and 12 weeks]
• compliance of the patient to the treatmen [Срок оценки: 6 weeks and 12 weeks]
• incontinence anal score [Срок оценки: 12 weeks]
• reduction of defecations per day and night [Срок оценки: 6 weeks and 12 weeks]
• time spent on bowel management (in the toilets room) [Срок оценки: 12 weeks]
• patient health organization and resources needed [Срок оценки: 12 weeks]
• improving the LARS score [Срок оценки: 6, 9 and 12 months]
• number of patients showing a change (reduction) of symptoms and consequences [Срок оценки: 6, 9 and 12 months]
• Preference of the patient and reason for it [Срок оценки: 12 month follow-up]

Критерии участия

Критерии включения

• Adult aged from 18 years
• Patients electively treated for rectal cancer with a low anterior resection
• Between 3 and 18 months after the conservative colorectal surgery or 3 and 18 months after the stoma reversal if applicable
• LARS score >= 25 (minor or major LARS) (Emmertsen and Laurberg 2012) AND LARS definition as consensus with at least one symptom that results in at least one consequence (Keane et al. 2020)
• Adult for whom previous conservative treatments were started for at least a month
• Mental and physical capability of the patient to handle the MiniGo by himself.
• Check of the anastomosis (no signs of leakage or clinical relevant stenosis) and absence of local recurrence by Rectal digital examination of the anastomosis, any other exam used in the current practice
• Patient affiliated to the health social security system

Критерии исключения

• Contra-indication to use TAI
• Former use of TAI (post colo-rectal surgery)
• Clinically relevant stenosis
• Current metastatic disease or local recurrence
• Ongoing chemotherapy
• Postoperative radiotherapy for rectal cancer
• History of diarrhoeal disease
• Inflammatory bowel disease
• Dementia
• Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant disease assessed to be a contributory cause to LARS symptoms.
• Patient with cancer recurrence
• Patient with a life expectancy < 1 year
• Participating to another clinical trial for the treatment of LARS symptom
• Ongoing pelvic floor rehabilitation/biofeedback
• Pregnancy or intention to become pregnant during the trial period
• Inability and unwillingness to give informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Франция · 9 центров

• CHU Amiens-Picardie — Amiens
• CHU Besançon — Besançon
• Clinique Tivoli-Ducos — Bordeaux
• CHU Grenoble — La Tronche
• CHU Timone — Marseille
• CHU de NANTES, Hôtel Dieu — Nantes
• CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE — Pessac
• CH Lyon Sud — Pierre-Bénite
• … и ещё 1 центр

Идентификаторы

NCT: NCT06923150 · 2023-A02656-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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