Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance

Официальное название

Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance - a Randomized Controlled Trial (iRECOVER)

Обзор

The goal of this clinical study is to gain further insights into the treatment of patients with Low Anterior Resection Syndrome (LARS) symptoms after rectal resection. The main question is: Can LARS symptoms and quality of life be improved by implementing an intensified follow-up program? Researchers will compare the results of the intervention group with the results of a control group in which patients do not receive an intensified follow-up program to determine whether the intervention works. Participants will undergo an intensified follow-up program which consists of several follow-up visits and medical treatment, pelvic floor muscle training and gynaecological and urological co-treatment in case of LARS symptoms and urinary or sexual complaints.

Подробное описание

Background: After surgical treatment of patients with rectal cancer, up to 65% experience a symptom complex known as LARS (Low Anterior Resection Syndrome). Those affected suffer from symptoms such as fecal incontinence, frequent bowel movements and a strong urge to defecate, which can severely impair their quality of life. Therapy options include treatment with medication such as bulking agents or drugs that reduce bowel motility, pelvic floor muscle training or stimulation of the nerves that control the function of the rectum and pelvic floor.

Objective: The aim of the present study is to investigate whether an intensified follow-up program can improve the LARS symptoms and consequently the quality of life of patients after rectal resection. If the planned study shows success of the program, we will be able to structurally improve the aftercare of those affected.

Methods: The study is being conducted at several centers in Switzerland, including St. Claraspital Basel. Patients who have had a rectal resection are recruited prior to the repositioning of the artificial bowel outlet, which was created during the primary operation, and randomly assigned to one of the both study groups (intensified follow-up or standard treatment). The symptoms are recorded using various questionnaires and patients will be treated according to our action plan. If LARS symptoms occur, patients receive drug treatment, pelvic floor physiotherapy and, if necessary, sacral neurostimulation, which means implanting a device which stimulates the nerves that control the function of the rectum and pelvic floor. If patients suffer from urinary problems or impaired sexual function they will be referred to our urology or gynecology department for further diagnosis and treatment.

Вмешательства

• Другое Intensified follow-up program
  The study intervention will be an intensified follow-up program which consists of different measures. Patients will attend follow-up visits 1, 4, 7 and 13 months after ileostomy repositioning, at which LARS symptoms, quality of life as well as sexual and urinary function will be recorded using various questionnaires. In case of LARS symptoms patients will receive medical treatment with loperamide and metamucil as well as pelvic floor muscle training (including biofeedback and home exercises). Re

Первичные конечные точки

• Improvement of the LARS score after 13 months [Срок оценки: 13 months after closure of ileostomy]

Вторичные конечные точки (10)

• Patients' quality of life (QoL) [Срок оценки: 1, 4, 7 and 13 months after closure of ileostomy]
• Urinary symptoms in women and men [Срок оценки: 1, 4, 7 and 13 months after closure of ileostomy]
• Sexual function in women [Срок оценки: 1, 4, 7 and 13 months after closure of ileostomy]
• Sexual function in men [Срок оценки: 1, 4, 7 and 13 months after closure of ileostomy]
• Readmission to hospital [Срок оценки: 13 months]
• Costs [Срок оценки: 13 months]
• Compliance to treatment intervention [Срок оценки: 13 months]
• Natural history of incidence of LARS symptoms in control group [Срок оценки: 13 months]
• Prevalence of LARS [Срок оценки: 13 months]
• Rate of secondary ostomy formation [Срок оценки: 13 months]

Критерии участия

Критерии включения

• patients older than 18 years
• patients with rectal cancer in the middle and lower third of the rectum in stages I to IV who underwent LAR with TME and protective ileostomy
• able to give informed consent as documented by signature

Критерии исключения

• dementia or other psychiatric disorder that would prevent the patients from answering the questionnaires and experiencing sustainable training effects
• impossibility of stoma reversal due to persistent anastomotic leak and/or local recurrence

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 5 центров

• Clarunis Universitäres Bauchzentrum Basel — Basel
• Lindenhofspital Bern — Bern
• St. Anna Spital Bern — Bern
• Kantonsspital Luzern — Lucerne
• Kantonsspital Winterthur — Winterthur

Публикации

• Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21. PMID 22504191
• Roberts RO, Jacobsen SJ, Jacobson DJ, Reilly WT, Talley NJ, Lieber MM. Natural history of prostatism: high American Urological Association Symptom scores among community-dwelling men and women with urinary incontinence. Urology. 1998 Feb;51(2):213-9. doi: 10.1016/s0090-4295(97)00505-0. PMID 9495700
• Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472. PMID 10637462

Идентификаторы

NCT: NCT06936774 · iRECOVER_2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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