Clinical trial NCT05245331: Transanal Irrigation for Low Anterior Resection Syndrome.
Official title: High-volume and Low-volume Water Transanal Irrigation for the Management of Low Anterior Resection Syndrome. A Crossover Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Anterior Resection Syndrome
Keywords: Rectal Cancer
LARS
Low Anterior Resection Syndrome
Transanal Irrigation
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Asociacion Española de Coloproctologia
name: Asociación Española de Cirugía
First posted: 2022-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 0-2.
* 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.

Primary outcomes:
measure: LARS score
timeFrame: day 1st, 30th, 60th, 75th, 105th, and 135th.
Secondary outcomes:
measure: Daily bowel movements number (total, day, and night)
timeFrame: recorded daylily during the last 15 days at basal time and at day 60th, 75th, and 135th)
measure: Short Form 36 quality of live questionnaire (SF-36)
timeFrame: day 1st, 30th, 60th, 75th, 105th, and 135th.
measure: Vaizey score
timeFrame: day 1st, 30th, 60th, 75th, 105th, and 135th.
measure: Satisfaction grade (VAS: 0-10).
timeFrame: day 1st, 30th, 60th, 75th, 105th, and 135th.
measure: Preferred treatments
timeFrame: day 135
measure: Adverse effects related to both treatments.
timeFrame: day 1 to 135.
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Bellvitge University Hospital
Study officials:
name: Loris Trenti, PhD
role: PRINCIPAL_INVESTIGATOR
References: