Transanal Irrigation for Low Anterior Resection Syndrome.

Launched by HOSPITAL UNIVERSITARI DE BELLVITGE · Feb 15, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods of transanal irrigation (TAI) to help people who have Low Anterior Resection Syndrome (LARS), a condition that can cause bowel issues after surgery for rectal cancer. The study will compare a high-volume irrigation method using the Peristeen Plus® system to a standard low-volume method using a 250ml water enema. The goal is to see which method works better in improving symptoms related to LARS.

To be eligible for this trial, participants should be adults aged 18 or older who have undergone certain types of rectal cancer surgery and are experiencing significant symptoms of LARS. They should have had at least one year since their surgery and be in relatively good health. Participants can expect to receive either of the two irrigation methods and will be monitored throughout the study to assess how well each method works for managing their symptoms. It's important to know that some people, like those with certain past surgical complications or active cancers, will not be eligible for this trial.

Gender

ALL

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.