Actively Recruiting
Led by F. D. Roosevelt University Hospital · Updated on 2024-07-25
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating the effectiveness of pelvic floor exercises in preventing low anterior resection syndrome (LARS) in patients after minimally invasive rectal surgery. LARS can cause symptoms like stool incontinence, urgency, and constipation, significantly affecting quality of life. This study aims to find out if pelvic floor exercises can reduce the occurrence or severity of LARS and assess patient adherence to home exercise programs after surgery. Participants will be randomly assigned to one of two groups: one will receive usual care without specific pelvic floor exercises, and the other will be instructed to perform pelvic floor exercises for one month after surgery. Before surgery and during the first four days after surgery, those in the exercise group will be guided by a physiotherapist to learn the exercises, which involve repeated muscle contractions practiced several times daily. Both groups will be followed up at 1, 6, and 12 months after surgery to assess LARS symptoms and, for the exercise group, adherence to the exercise program. During the study, participants will complete questionnaires to measure the presence and severity of LARS using the LARS questionnaire. The exercise group will also complete the Exercise Adherence Rating Scale after one month. The study will monitor quality of life and the degree of LARS at various time points. Participants are expected to continue their usual care throughout the study, which lasts at least 12 months post-surgery.
CONDITIONS
Effectiveness of Pelvic Floor Exercise to Prevent LARS (Low Anterior Resection Syndrome)
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 month
Participants in the intervention group perform specific pelvic floor exercises after surgery to prevent Low Anterior Resection Syndrome (LARS). Exercises involve repeated pelvic floor muscle contractions and activation during movements, practiced 4-5 times per day for one month.
1 instruction visit and follow-up assessments at 1 month post-surgery
Duration - Up to 12 months post-surgery
Participants are questioned about the possible development of LARS and adherence to pelvic floor exercises at 1, 6, and 12 months after surgery.
3 follow-up visits at 1, 6, and 12 months (in-person or remote)
Total: 1 location
1
F.D.Roosevelt University Hospital in Banská Bystrica
Banská Bystrica, Slovakia, 97517
Actively Recruiting
B
Barbara Mrázová, MD,MPH
V
Viktória Durajová, Ing,PhD,MBA
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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