Status:
ACTIVE_NOT_RECRUITING
Transanal Irrigation for Low Anterior Resection Syndrome.
Lead Sponsor:
Hospital Universitari de Bellvitge
Collaborating Sponsors:
Asociacion Española de Coloproctologia
Asociación Española de Cirugía
Conditions:
Low Anterior Resection Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to investigate whether the high-volume transanal irrigation (TAI) performed by the Peristeen Plus® system is superior to the low-volume TAI performed by standard 250ml water e...
Detailed Description
Most of the patients operated on for rectal cancer present defecatory disfunction symptoms known as Low Anterior Resection Syndrome (LARS) of different degree and severity. Although, transanal irrigat...
Eligibility Criteria
Inclusion
- Personal history of LAR or ultra-LAR with total mesorectal excision (TME) and sphincter preservation with stapled or manual end to end anastomosis for primary rectal cancer.
- Major LARS (score 30-42).
- At least 1 year follow-up after LAR or ultra-LAR or temporary stoma closure.
- Anastomotic integrity demonstrated by endoscopic, radiologic or clinical examination.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0-2.
- Age≥ 18 years
Exclusion
- Side to end mechanical anastomosis or J-pouch colorectal anastomosis
- Partial or total intersphincteric resection.
- Personal history of anastomotic dehiscence, chronic pelvic sepsis, anastomotic sinus, anastomotic stricture or other any other anastomotic complications.
- Persona history of other colorectal, proctologic or pelvis surgery or disease.
- Personal history of bariatric surgery.
- Functioning sacral neurostimulator carriers.
- Previous use of transanal irrigation systems for LARS treatment
- Presence of an ostomy.
- Local or distant rectal cancer recurrence and/or any other active neoplastic disease.
- Altered cognitive status.
- Pregnancy and age \< 18 years
- Any other diseases that may alter results of the study.
- Refusal to sign the informed consent.
Key Trial Info
Start Date :
August 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05245331
Start Date
August 4 2022
End Date
November 1 2025
Last Update
September 16 2025
Active Locations (2)
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1
Bellvitge University Hospital
Barcelona, Barcelona, Spain, 08907
2
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907