Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance (iRECOVER)
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About
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.
Full description
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.
Enrollment
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Inclusion criteria
- 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
Exclusion criteria
- 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
Trial design
Primary purpose
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Interventional model
Masking
140 participants in 2 patient groups
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Central trial contact
Felicitas Wiedemann, Resident; Marco von Strauss und Torney, Senior physician
Data sourced from clinicaltrials.gov
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