Transanal Irrigation for Low Anterior Resection Syndrome.
Spain20 participantsStarted 2022-08-04
Plain-language summary
The aim of this study is to investigate whether the high-volume transanal irrigation (TAI) performed by the Peristeen PlusĀ® system is superior to the low-volume TAI performed by standard 250ml water enema for the treatment of Low Anterior Resection Syndrome (LARS).
Who can participate
Age range18 Years
SexALL
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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.
* Ageā„ 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.
What they're measuring
1
LARS score
Timeframe: day 1st, 30th, 60th, 75th, 105th, and 135th.