Clinical Research Directory

A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients

This clinical trial studies if a bowel management program with a retrograde rectal enema (RRE) for the treatment of low anterior resection syndrome (LARS) in rectal cancer patients is better than medical management alone. Rectal cancer treatment can include a procedure where part of the rectum with cancer is removed and the remaining part of the rectum is reconnected to the colon, this is called a low anterior resection of the rectum. LARS is a common condition that can develop after undergoing a low anterior resection of the rectum. LARS consists of any change in how the body performs defecation, the discharge of feces from the body, after undergoing a resection procedure. Patients with LARS may experience fecal urgency, incontinence, increased frequency, constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Patients may experience individual symptoms of LARS or a combination of them. A bowel management program assists patient's with identifying a specific bowel management regimen that works best for managing symptoms of LARS. A RRE consists of inserting a catheter through the anus into the rectum. The RRE is designed to assist fecal emptying. Medical management of LARS can include the use of fiber, loperamide hydrochloride, or pelvic floor physical therapy. Fiber may help relieve constipation, feelings of incomplete bowel movement, or bowel emptying difficulties. Loperamide hydrocholoride may help lessen fecal urgency, incontinence, or increased frequency. Pelvic floor physical therapy may help restore strength in the rectum possibly helping to improve symptoms of LARS. Participating in a bowel management program with a RRE may be more effective in treating LARS than medical management alone.

Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer

The goal of this study is to compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life. The main questions it aims to answer are: the difference of anal function 1 year after surgery type of study: clinical trial participant population: patients with low rectal cancer Participants will receive Parks operation of Bacon operation If there is a comparison group: Researchers will compare Parks and Bacon operation to see if the anal function 1 year after surgery is different.

The Effects of Kegel Exercise Combined With Biofeedback Therapy on Bowel Function Recovery, Emotional Distress, and Quality of Life in Patients Following Low Anterior Resection for Rectal Cancer

This randomized controlled trial aims to evaluate the effects of combining Kegel exercise with a single biofeedback session on bowel function, emotional distress, and quality of life in patients who have undergone low anterior resection (LAR) for rectal cancer. Low anterior resection syndrome (LARS) is a common postoperative complication following LAR, characterized by increased stool frequency, urgency, and incontinence, which can significantly impair patients' psychological well-being and daily quality of life. Participants will be randomly assigned to one of two groups: (1) Kegel exercise combined with one non-invasive biofeedback session, or (2) Kegel exercise alone. Both groups will perform home-based Kegel exercises for eight weeks. The study aims to determine whether the combined biofeedback and Kegel exercise intervention results in greater improvements in bowel control, emotional well-being, and quality of life compared with Kegel exercise alone.

Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)

Transanal irrigation (TAI) has shown to improve fecal incontinence and increase quality of life in patients with low anterior resection syndrome (LARS). This trial is a small study being conducted to determine whether a larger trial is feasible. Investigators are also doing this research to see if TAI impacts quality of life and improves bowel function within the early post-operative period (1-12 months). This treatment is designed for participants to have more control over their bowel movements and reduce the dependency on immediate access to the toilet.

Transanal Irrigation for Low Anterior Resection Syndrome.

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).

Transanal Irrigation for the Management of LARS

This study aims to evaluate the impact of Transanal irrigation (TAI) on the quality of life and low anterior resection symptoms (LARS) in Canadian rectal cancer survivors living with minor to major LARS. It proposes to teach TAI through a novel online platform and to provide virtual nursing support for the participants. To our knowledge, this is the first North American based and largest randomized control trial on the use of TAI for patients with LARS. This will also be the first study to teach and support patients through the TAI process using a virtual platform. While TAI has been demonstrated to reduce LARS scores and increased QoL in patients with significant LARS, its feasibility and acceptance for Canadian patients remains uncertain. Furthermore despite the existing studies, the rate of TAI seems to be low in North America. The hypothesis is that TAI, taught and supported through an online portal dedicated to LARS patients, will positively impact QoL and improve LARS symptoms. The results of this trial may allow TAI to become part of the standard armamentarium that clinicians offer patients for LARS management, with the presence of online nursing support and guidance to facilitate this practice.

Bowel Dysfunction After Low Rectal Resection. An Pilot Study Using Psyllium Husk In Rectal Cancer Patients.

Rectal cancer constitutes 1/3 of more than 4500 annually diagnosed cases of colorectal (CRC) in Norway. With the advances in radiochemotherapy, and surgical techniques, the long-term survival rate is increasing after surgery regardless of the rising incidences, with a 73% 5-year survival rate in Norway (89% for stage I-III cancer). Low anterior resection (LAR) is the most commonly performed surgical procedure with curative intent with over 500 procedures per year in Norway alone. 80 % of patients subjected to LAR suffer from the LAR syndrome (LARS) which includes grades of bowel incontinence, urgency and tenesmus contributing to reduced quality of life (QoL). Suggested means of management have been advocated without preceding randomized trials. Psyllium husk has been suggested as a nutritional supplement for symptom reduction in patients suffering from LARS, but data is limited and no larger, randomized studies regarding its effect on patients with low anterior resection syndrome have been conducted. In this pilot study preceeding a placebo-controlled RCT, the investigators aim to improve documentation of a proposed management strategy. The investigators anticipate that a reduction in intestinal symptomburden will increase QoL for this large patientgroup.

Retrograde and Antegrade Enema for Prevention of LARS After LAR: a Randomized Controlled Trial

The goal of this clinical trial is to learn if enema works to prevent low anterior resection syndrome (LARS) in adults. The main questions it aims to answer are: 1. To describe the level of stoma adaptation before and after the patients received enemas during the stoma period as well as the levels and trends of LARS, bowel function, sleep quality, and quality of life after stoma reduction surgery 2. To compare the effects and advantages and disadvantages of antegrade and retrograde enema, and to investigate whether these two types of enema can provide safe and effective preventive measures for the prevention of LARS, the improvement of bowel function, and the enhancement of sleep and quality of life in rectal cancer patients after low anterior resection. Researchers will compare antegrade enema, retrograde enema, and the standard of care to see if these two types of enema work to prevent LARS. Participants will: 1. Receive either antegrade or retrograde enema or no enema based on the standard of care at 1 month after anterior rectal resection, until the ileostomy reversal. 2. Keep a diary of their symptoms.

Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial

Sphincter sparing rectal resection surgery, either total mesorectal excision (TME) with a temporary loop ileostomy or partial mesorectal excision (PME), is the mainstay of rectal cancer treatment , however, these treatments are associated with the development of Low anterior resection syndrome (LARS). This syndrome is characterized by a constellation of symptoms such as fecal frequency, urgency and clustering of bowel movements and can lead to fecal and flatus incontinence. There is no gold standard therapy designed to treat the root cause of the problems associated with LARS. Paula Method of exercises, based on the theory that the body has the natural ability to self-heal and that all sphincter muscles in the body affect one another other and thus, exercising one healthy region can positively impact another. The purpose of this study is to evaluate the usefulness of the Paula Method of exercises in patients post sphincter sparing rectal resection surgery with LARS Syndrome.

Transanal Irrigation for Low Anterior Resection Syndrome

The preservation surgery of the anal sphincter muscle has become the standard procedure in the treatment of rectal cancer and, thanks to advancements in surgical techniques, can now be performed for tumors located closer to the anus. This method allows patients to avoid a permanent artificial anus, maintaining continuity of the intestines and enabling bowel movements through the anus, making it a highly preferred procedure. Furthermore, advancements in various tumor treatments have led to improved long-term survival rates. Preservation surgery of the anal sphincter muscle is commonly used in the treatment of rectal cancer, resulting in approximately 90% of patients experiencing changes in bowel habits after surgery. These changes include characteristic diarrhea, urgent bowel movements, frequent bowel movements, and fecal incontinence, collectively known as Anterior Resection Syndrome (ARS). Particularly in the case of low rectal cancer, it often manifests as Low Anterior Resection Syndrome (LARS). These symptoms are most severe immediately after surgery, generally persisting in a significant degree for 1-2 years, with some improvement over time. However, for many patients, LARS remains a lifelong challenge, significantly impacting their quality of life. Nighttime symptoms of LARS, in particular, have a profound effect on sleep quality, potentially leading to a decline in overall quality of life. Currently, there is no definitive method to completely cure LARS, and the available approaches focus on empirical treatments or short-term symptom control using medications such as loperamide. Loperamide directly affects the neuromuscular system of the intestine, reducing its motility. This prolongs the time food stays in the intestine, allowing sufficient absorption of moisture and electrolytes, consequently reducing symptoms of diarrhea. Loperamide is available in two forms: loperamide oxide and loperamide hydrochloride. While loperamide oxide products like Arestal® were prescribed by doctors until August 2017, the approval was revoked, leaving loperamide hydrochloride as the only form used domestically. It comes in a single product containing 2 mg of loperamide hydrochloride and a combination product with 0.25 mg of loperamide hydrochloride, a sterilizing agent in the intestine (e.g., acrylonitrile, berberine), and an antispasmodic. Transanal irrigation (TAI) is a method where patients self-administer water into the rectum through an enema, physically cleansing the anus and rectum. This technique is often used for patients with chronic constipation or fecal incontinence. TAI has proven beneficial, particularly in improving symptoms for patients experiencing bowel dysfunction following sphincter-preserving surgery, especially for those who underwent low anterior resection. However, there is currently no research on the utility and safety of TAI for LARS patients, specifically addressing whether it can improve the nighttime symptoms associated with LARS syndrome and enhance sleep quality. Therefore, this study aims to investigate the impact of TAI on the symptoms of LARS syndrome.

Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer.

This study hypothesizes that approximately 50% of rectal cancer patients can preserve their rectum using a watch-and-wait strategy if they achieve a complete or near-complete clinical response to total neoadjuvant therapy (TNT). The objective is to determine whether the complications, quality of life, and survival rates of rectal cancer patients who have achieved a complete or near-complete clinical response to TNT, followed by a watch-and-wait approach, are comparable to those of patients who undergo surgery first. Additionally, the study aims to identify potential prognostic and predictive markers for rectal cancer and examine survival rates and factors influencing responses to chemoradiotherapy (CRT) or TNT. The study is divided into two parts: \*\*Part One:\*\* Participants with cT1N1, T2-T3 N0-1 rectal cancer, MRF-, and EMVI-, with surgery as one of the possible first-line treatment options, will be randomized into two groups. The experimental group will consist of participants receiving TNT, including CRT and consolidation chemotherapy (Ch). If these participants achieve a complete or near-complete clinical response, they will be observed using a watch-and-wait strategy, which is a non-operative approach. The control group will consist of participants who undergo surgical treatment initially. \*\*Part Two:\*\* All participants with rectal cancer who have received CRT or TNT will be included. Additionally, participants diagnosed with rectal cancer who are scheduled for CRT or TNT but declined to participate in Part One or do not meet the inclusion criteria will also be included.

Exploring the Effect of Colonic J-pouch in Anorectal Preservation Surgery for Ultra-low Rectal Cancer.

The occurrence of colorectal cancer has increased from the third most common cancer in 2018 to the second most common cancer in 2023. The practice of anal preservation surgery for ultra-low rectal cancer is being adopted gradually. Ultra-low rectal cancer patients who have undergone anal preservation are at an increased risk of developing significant bowel complications. The objective of this study was to examine the relationship between the type of bowel reconstruction following anal preservation surgery, and the subsequent outcomes of bowel function, quality of life and complication rates in patients with ultra-low rectal cancer.

The Effects of Colorectal Prehabilitation Via Reinfusion or Retention Enema of Ileal Contents Filtrate on the Defecation Functions for the LAR Patients With Ileostomy Before Stoma Closure

This study was a single-center RCT study to compare the effect of preoperative prehabilitation treatment of ileostomy contents filtrate reinfusion through distal ileocolon or retention of enema colon with that of traditional treatment in patients with bowel function after stoma closure.

Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial

Study Purpose: This study aims to understand how pelvic floor rehabilitation (PFR) after low anterior resection (LAR) surgery for rectal cancer affects bowel control and quality of life compared to usual care. Background: Rectal cancer and its treatments can significantly impact patients' lives, often causing bowel issues like frequent bowel movements, urgency, and incontinence. These problems, known as low anterior resection syndrome (LARS), affect 70-90% of patients and can last for over two years. (1,2) Current Knowledge: Advances in treatments have improved survival rates and recovery. Despite improvements, many patients still experience bowel issues after surgery. Past studies show PFR can help, but they have limitations like small sample sizes and varied methods. (3-5) Need for the Study: There is a need for a well-designed study to confirm the benefits of PFR and to identify which patients benefit the most. Study Design: This study is a randomized controlled trial that will: * Compare PFR to usual care in patients after LAR surgery. * Focus on bowel control and quality of life. * Provide detailed insights to improve aftercare for rectal cancer patients.

Fecal Microbiota Transplantation in the Treatment of Major LARS

Randomized trial to assess FMT efficacy in improving bowel function for major LARS patients. 40 subjects, blinded, randomized to FMT or probiotics. Pre-post 16S sequencing, 4-week follow-up for bowel symptoms, 8-week microbiota analysis.

The Safety and Efficacy of Transanal Irrigation in Patients With Sleep Disturbance From Low Anterior Resection Syndrome After Rectal Cancer Surgery (TraLARS)

The preservation surgery of the anal sphincter muscle has become the standard procedure in the treatment of rectal cancer and, thanks to advancements in surgical techniques, can now be performed for tumors located closer to the anus. This method allows patients to avoid a permanent artificial anus, maintaining continuity of the intestines and enabling bowel movements through the anus, making it a highly preferred procedure. Furthermore, advancements in various tumor treatments have led to improved long-term survival rates. Preservation surgery of the anal sphincter muscle is commonly used in the treatment of rectal cancer, resulting in approximately 90% of patients experiencing changes in bowel habits after surgery. These changes include characteristic diarrhea, urgent bowel movements, frequent bowel movements, and fecal incontinence, collectively known as Anterior Resection Syndrome (ARS). Particularly in the case of low rectal cancer, it often manifests as Low Anterior Resection Syndrome (LARS). These symptoms are most severe immediately after surgery, generally persisting in a significant degree for 1-2 years, with some improvement over time. However, for many patients, LARS remains a lifelong challenge, significantly impacting their quality of life. Nighttime symptoms of LARS, in particular, have a profound effect on sleep quality, potentially leading to a decline in overall quality of life. Currently, there is no definitive method to completely cure LARS, and the available approaches focus on empirical treatments or short-term symptom control using medications such as loperamide. Loperamide directly affects the neuromuscular system of the intestine, reducing its motility. This prolongs the time food stays in the intestine, allowing sufficient absorption of moisture and electrolytes, consequently reducing symptoms of diarrhea. Loperamide is available in two forms: loperamide oxide and loperamide hydrochloride. While loperamide oxide products like Arestal® were prescribed by doctors until August 2017, the approval was revoked, leaving loperamide hydrochloride as the only form used domestically. It comes in a single product containing 2 mg of loperamide hydrochloride and a combination product with 0.25 mg of loperamide hydrochloride, a sterilizing agent in the intestine (e.g., acrylonitrile, berberine), and an antispasmodic. Transanal irrigation (TAI) is a method where patients self-administer water into the rectum through an enema, physically cleansing the anus and rectum. This technique is often used for patients with chronic constipation or fecal incontinence. TAI has proven beneficial, particularly in improving symptoms for patients experiencing bowel dysfunction following sphincter-preserving surgery, especially for those who underwent low anterior resection. However, there is currently no research on the utility and safety of TAI for LARS patients, specifically addressing whether it can improve the nighttime symptoms associated with LARS syndrome and enhance sleep quality. Therefore, this study aims to investigate the impact of TAI on the quality of sleep in patients with nighttime symptoms of LARS syndrome.

Impact of Early Postoperative Treatment With Posterior Tibial Nerve Stimulation on the Incidence and Duration of Low Anterior Rectal Resection Syndrome

The treatment of rectal cancer is currently based on surgical resection of the rectum with total excision of the mesorectum, associated with neoadjuvant radiochemotherapy. Surgical resections with sphincter preservation are frequently (60% of cases) associated with problems related to intestinal and defecatory function, which together are called Anterior Resection Syndrome (ARS) with varying degrees of severity. Among the different treatments the investigators find posterior tibial nerve stimulation, a simple and non-invasive technique, which is currently used. The study aims to analyze whether postoperative posterior tibial nerve stimulation in patients undergoing low anterior resection of the rectum has an impact on the incidence and duration of low anterior resection syndrome (LARS) and therefore on the quality of life of patients undergoing this type of intervention. Therefore, treatment with PNTS is currently established for the management of LARS symptoms. Given that a large percentage of patients operated on for rectal neoplasms will develop this syndrome, the investigators intend to apply this treatment before the onset of symptoms in patients at risk for LARS. It is also an intervention with a low rate of side effects, the benefit that the investigators can obtain from its preventive application is clearly superior to the risk of undergoing such treatment. The investigators´ hypothesis is: Posterior tibial stimulation for 6 weeks post-operative of low anterior resection with anastomosis has a favorable impact by reducing the incidence and duration of ARS and improving the quality of life of patients undergoing anterior rectal resections for cancer.

Assessment of Quality of Life After Low Anterior Resection During Cytoreductive Surgery for Advanced Ovarian Cancer

This study aims to evaluate the incidence of low anterior resection syndrome and quality of life after cytoreductive surgery for advanced ovarian cancer patients.

Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome

The study is a multicentre randomized controlled trial with the objective to compare the effect of transanal irrigation with glycerol suppositories in patients suffering from major Low Anterior Resection Syndrome (LARS).