Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2026-01-26 @ 11:03 AM
Study NCT ID:
NCT06519006
Status:
RECRUITING
Last Update Posted:
2024-07-25
First Post:
2024-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Pelvic Floor Exercise to Prevent LARS (Low Anterior Resection Syndrome)
Sponsor:
F. D. Roosevelt University Hospital
Organization:
Study Overview
Official Title:
Effectiveness of Pelvic Floor Exercise to Prevent LARS (Low Anterior Resection Syndrome) After Mini-invasive Low Anterior Resection in Patients With Rectal Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CH1
Brief Summary:
The main aim of this randomized study will be to determine the effectiveness of pelvic floor exercises on the incidence or severity of LAR syndrome in patients after mini-invasive rectal resection.
The main questions it aims to answer are:
* Does pelvic floor exercise after low anterior resection prevent LARS (low anterior resection syndrome)?
* What is the adherence of patients to prescribed home exercise after surgery?
* Quality of life after LAR
Researchers will compare the group of patients with pelvic floor exercises to those without and determine the occurrence and severity of LARS.
Participants will:
* under the professional guidance of a physiotherapist, the day before surgery and in the first 4 postoperative days be educated to exercise the pelvic floor
* continue exercise at home for a month (according to the instructions together with the infographic)
The main questions it aims to answer are:
* Does pelvic floor exercise after low anterior resection prevent LARS (low anterior resection syndrome)?
* What is the adherence of patients to prescribed home exercise after surgery?
* Quality of life after LAR
Researchers will compare the group of patients with pelvic floor exercises to those without and determine the occurrence and severity of LARS.
Participants will:
* under the professional guidance of a physiotherapist, the day before surgery and in the first 4 postoperative days be educated to exercise the pelvic floor
* continue exercise at home for a month (according to the instructions together with the infographic)
Detailed Description:
Advances in the surgical treatment of rectal diseases lead to better oncological results, a higher chance of preserving the sphincters, and thus a lower number of permanent stomas. However, the preserved anus does not always have to perform its original function fully. All patients after a low anterior resection of the rectum are at risk of developing functional disorders, the so-called LARS (low anterior resection syndrome). Patients may develop varying degrees of functional anorectal disorder, from urgency, stool incontinence to constipation. The prevalence of LARS ranges from 41-80% and is a significant factor in reducing the quality of life.
The therapy of LAR syndrome, depending on the severity, consists of medication, transanal irrigation, pelvic floor rehabilitation, neurostimulation or surgery. The most effective is a combination of treatment modalities. Given the lack of high-quality evidence in this area, recommendations are generally based on retrospective studies or extrapolated from studies of non-surgical patients with similar gastrointestinal disorders. Suppose the disease is present 1-2 years after the surgery and all treatment modalities are exhausted. In that case, the patient is offered a permanent removal of the stoma, which has a lifelong impact on the patient.
According to the available data, it is possible to prevent the occurrence of LARS through postoperative pelvic floor exercises, however, relevant studies are missing The pelvic floor is a ligament-muscle system that provides dynamic support for the organ systems located in the small pelvis - the urinary system, the genitals, and the intestinal organs.
Exercise of the pelvic floor muscles plays an important role in patients suffering from incontinence, pelvic organ prolapse, or rectal prolapse. Strengthening the muscles can serve as a follow-up treatment after surgical procedures including prevention of LARS.
The resulting knowledge of the possibility of preventing LARS will have a fundamental impact on clinical practice and patient management.
The therapy of LAR syndrome, depending on the severity, consists of medication, transanal irrigation, pelvic floor rehabilitation, neurostimulation or surgery. The most effective is a combination of treatment modalities. Given the lack of high-quality evidence in this area, recommendations are generally based on retrospective studies or extrapolated from studies of non-surgical patients with similar gastrointestinal disorders. Suppose the disease is present 1-2 years after the surgery and all treatment modalities are exhausted. In that case, the patient is offered a permanent removal of the stoma, which has a lifelong impact on the patient.
According to the available data, it is possible to prevent the occurrence of LARS through postoperative pelvic floor exercises, however, relevant studies are missing The pelvic floor is a ligament-muscle system that provides dynamic support for the organ systems located in the small pelvis - the urinary system, the genitals, and the intestinal organs.
Exercise of the pelvic floor muscles plays an important role in patients suffering from incontinence, pelvic organ prolapse, or rectal prolapse. Strengthening the muscles can serve as a follow-up treatment after surgical procedures including prevention of LARS.
The resulting knowledge of the possibility of preventing LARS will have a fundamental impact on clinical practice and patient management.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: