High-volume and Low-volume Water Transanal Irrigation for the Management of Low Anterior Resection Syndrome. A Crossover Randomized Controlled Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- LARS score
Study Overview
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 enema for the treatment of Low Anterior Resection Syndrome (LARS).
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 irrigation (TAI) has been shown to be useful in improve LARS and quality of life of these patients no evidence exists about the best way to realize TAI in terms of irrigation volume and systems and frequency of irrigation. This crossover randomized controlled trial aims to evaluate the impact of two different type of TAI (high-volume by Peristeen Plus® and low-volume performed by 250ml water enema) on LARS and quality of life in patients with major LARS secondary to low anterior rectal resection (LAR) for primary rectal cancer. The primary outcome is the reduction of LARS score after two months of treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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-
- •Age≥ 18 years
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
LARS score
Time Frame: day 1st, 30th, 60th, 75th, 105th, and 135th.
LARS score changes with treatments. No LARS: 0-20; Minor LARS 21-29; Major LARS 30-42.
Secondary Outcomes
- Daily bowel movements number (total, day, and night)(recorded daylily during the last 15 days at basal time and at day 60th, 75th, and 135th))
- Adverse effects related to both treatments.(day 1 to 135.)
- Vaizey score(day 1st, 30th, 60th, 75th, 105th, and 135th.)
- Short Form 36 quality of live questionnaire (SF-36)(day 1st, 30th, 60th, 75th, 105th, and 135th.)
- Satisfaction grade (VAS: 0-10).(day 1st, 30th, 60th, 75th, 105th, and 135th.)
- Preferred treatments(day 135)
Investigators
Loris Trenti
Principal Investigator
Hospital Universitari de Bellvitge