Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05368168
Status:
RECRUITING
Last Update Posted:
2023-07-06
First Post:
2022-05-04
Brief Title:
Impact of Early Postoperative Treatment With Posterior Tibial Nerve Stimulation on the Incidence and Duration of Low Anterior Rectal Resection Syndrome
Sponsor:
Innovacion en Cirugía Vigo
Organization:
Innovacion en Cirugía Vigo
Study Overview
Official Title:
Impact of Early Postoperative Treatment With Posterior Tibial Nerve Stimulation on the Incidence and Duration of Low Anterior Rectal Resection Syndrome
Status:
RECRUITING
Status Verified Date:
2023-07
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:
LARS
Brief Summary:
The treatment of rectal cancer is currently based on surgical resection of the rectum with total excision of the mesorectum associated with neoadjuvant radiochemotherapy
Surgical resections with sphincter preservation are frequently 60 of cases associated with problems related to intestinal and defecatory function which together are called Anterior Resection Syndrome ARS with varying degrees of severity
Among the different treatments the investigators find posterior tibial nerve stimulation a simple and non-invasive technique which is currently used
The study aims to analyze whether postoperative posterior tibial nerve stimulation in patients undergoing low anterior resection of the rectum has an impact on the incidence and duration of low anterior resection syndrome LARS and therefore on the quality of life of patients undergoing this type of intervention
Therefore treatment with PNTS is currently established for the management of LARS symptoms Given that a large percentage of patients operated on for rectal neoplasms will develop this syndrome the investigators intend to apply this treatment before the onset of symptoms in patients at risk for LARS It is also an intervention with a low rate of side effects the benefit that the investigators can obtain from its preventive application is clearly superior to the risk of undergoing such treatment
The investigators hypothesis is Posterior tibial stimulation for 6 weeks post-operative of low anterior resection with anastomosis has a favorable impact by reducing the incidence and duration of ARS and improving the quality of life of patients undergoing anterior rectal resections for cancer
Surgical resections with sphincter preservation are frequently 60 of cases associated with problems related to intestinal and defecatory function which together are called Anterior Resection Syndrome ARS with varying degrees of severity
Among the different treatments the investigators find posterior tibial nerve stimulation a simple and non-invasive technique which is currently used
The study aims to analyze whether postoperative posterior tibial nerve stimulation in patients undergoing low anterior resection of the rectum has an impact on the incidence and duration of low anterior resection syndrome LARS and therefore on the quality of life of patients undergoing this type of intervention
Therefore treatment with PNTS is currently established for the management of LARS symptoms Given that a large percentage of patients operated on for rectal neoplasms will develop this syndrome the investigators intend to apply this treatment before the onset of symptoms in patients at risk for LARS It is also an intervention with a low rate of side effects the benefit that the investigators can obtain from its preventive application is clearly superior to the risk of undergoing such treatment
The investigators hypothesis is Posterior tibial stimulation for 6 weeks post-operative of low anterior resection with anastomosis has a favorable impact by reducing the incidence and duration of ARS and improving the quality of life of patients undergoing anterior rectal resections for cancer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None