Transanal Irrigation for Rectal Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Jewish General Hospital, Montreal, Canada
Rectal Carcinoma+2 More
Transanal Irrigation - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new way to treat LARS can improve quality of life and reduce symptoms.

See full description

Eligible Conditions

  • Rectal Carcinoma
  • Low Anterior Resection Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Transanal Irrigation will improve 1 primary outcome and 4 secondary outcomes in patients with Rectal Carcinoma. Measurement will happen over the course of Will be taken in first and last 2 week periods of each treatment groups.

Monthly for the seven months of the trial
EORTC-QLQ-C30
LARS Score
Satisfaction Survery
Satisfaction Survey
Week 2
Bowel diaries

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Tradition care Control arm
1 of 2
Transanal Irrigation
1 of 2
Active Control
Experimental Treatment

This trial requires 64 total participants across 2 different treatment groups

This trial involves 2 different treatments. Transanal Irrigation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Transanal Irrigation
Procedure
This group will be instructed on the use of TAI to be perform daily for the three month duration of their treatment arm
Tradition care Control armThis group tradition care group will have no modification to the care they have received prior to commencing the study. The patients in this group will use the usual dietary modifications and medications prescribed by the treating team to manage their LARS. No changes will be made to the treatment regime prescribed by their surgeon.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: monthly for the seven months of the trial
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly monthly for the seven months of the trial for reporting.

Who is running the study

Principal Investigator
D. M. B.
Prof. Dr. Marylise Boutros, MD
Jewish General Hospital

Closest Location

Jewish General Hospital - Montreal, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Low anterior resection by a laparoscopic, robotic, transanal total mesorectal excision, or open approach with (or without) creation of a diverting loop ileostomy for the treatment of rectal cancer, advanced adenoma or dysplasia
have had their ileostomy closed (if applicable)
completed treatment at least 6 months ago (including ileostomy closure)
LARS score > 20 points

Patient Q&A Section

What are common treatments for syndrome?

"In general, the treatments that have positive outcomes in common are the therapies with the greatest effect and fewer side effects. The common treatments with the most promising effect are: (1) estrogen therapy, and (2) antidepressant therapy for men with a depressive disorder that is the basis of the syndrome. No cures are available for most syndromes." - Anonymous Online Contributor

Unverified Answer

What causes syndrome?

"It has long been recognized that there can be common syndromes or diseases to which patients have related symptoms. When these symptoms are sufficiently common in a population, they may constitute what we call a syndrome. The existence of syndromes or diseases must thus be accepted as a possible fact." - Anonymous Online Contributor

Unverified Answer

How many people get syndrome a year in the United States?

"Overall, approximately 100,000 people a year are diagnosed with a syndrome in the United States. More than half of these were of diagnostic confidence. Patients most often see a psychiatrist, general internist, or family doctor and more than one of these type of providers is usually required to accurately diagnose a syndrome." - Anonymous Online Contributor

Unverified Answer

What are the signs of syndrome?

"Symptoms can be quite specific and require further assessment, for example a differential diagnosis includes depression, anxiety, post trauma stress. A full history and physical examination remain the cornerstone of an accurate diagnostic pathway. A definitive diagnosis may not be achieved however; a diagnosis should not delay specialist treatment." - Anonymous Online Contributor

Unverified Answer

What is syndrome?

"The term syndrome has a double meaning. It is used to denote a group of related conditions and may describe the pattern of symptoms. On the other hand, syndromes are clinical descriptions. In the most literal and historical sense syndromes include only a small number of diseases. The use of the term syndrome is often disputed, but is the preferred style for communication among clinicians. In the strict sense a syndrome is different from a disease. A diagnosis, a clinical sign, symptom, or pattern, is not a syndrome but a disease (or in fact an arbitrary taxonomic category). A symptom is similar to a disease when it accounts for a disease in a way that makes diagnosis difficult." - Anonymous Online Contributor

Unverified Answer

Can syndrome be cured?

"The syndrome of bipolar II disorder and ADHD, a combination formerly thought a psychiatric morbidity with no specific treatment, might be curable in some cases with psychotherapy. Prospective studies are needed to evaluate the validity of such a possibility." - Anonymous Online Contributor

Unverified Answer

Is transanal irrigation typically used in combination with any other treatments?

"TAI is often recommended with any treatment; however, to reduce the risk of infection from fecal material transmission, combination of TAI seems to be more favorable than using TAI alone." - Anonymous Online Contributor

Unverified Answer

How serious can syndrome be?

"Syndromes can have a tremendous effect on the quality of life and can affect a person's future ability to work. With proper treatment, most patients with syndrome will be able to return to (full) work. [When you have a syndrome, find out how it affects workplace activities and what it takes to remain productive (https://whsover.com/-/how-to-return-to-work/syndromes) so you can understand your job and work on a way to improve your job performance] (https://whsover.com/-/how-to-return-to-work/syndromes)." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving transanal irrigation?

"[In our experience (https://www.withpower.com/d+-schizophrenia)] (http://power.withpower.com/c-schiz/c-schiz=1) a significant number of patients who use transanal irrigation report a better symptom control and improvement in the quality of life." - Anonymous Online Contributor

Unverified Answer

What does transanal irrigation usually treat?

"The symptoms that typically improve with anorectal irrigation can be divided into three groups: irritative complaints such as dyspareunia; anorectal pathology such as constipation or anal fissures; and constipation itself. [Syndromes (n=6) are defined by their presence or absence at baseline and after treatment." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of transanal irrigation?

"Transanal irrigation is effective in the management of symptomatic chronic anal fissures and symptomatic rectal fissured and hemorrhoid hemorrhoids. It is associated with high satisfaction rates among patients and can be safely performed. When the side effects were assessed, it was found that transanal irrigation is well tolerated by patients. It can be considered a safe and effective alternative for the treatment of both anterior and posterior fissures, hemorrhoid diseases, anal ulcers, chronic anal fissures. Also, it can offer a useful and reliable alternative to surgery for the management of fissure and hemorrhoid diseases." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of syndrome?

"Based on the current understanding of the syndrome, we suggest that the primary causes were related to abnormal differentiation of the mesenchymal stem cells due to an unknown factor. We suggest there is a high chances of the disorder to be caused by a genetic mutation of one of the genes related to [bone cancer](https://www.withpower.com/clinical-trials/bone-cancer). The disorder was found to be associated with one to four types of cancer." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Rectal Carcinoma by sharing your contact details with the study coordinator.