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Low Anterior Resection Syndrome clinical trials

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NCT ID: NCT06274190 Not yet recruiting - Rectal Cancer Clinical Trials

Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients

Treatable
Start date: February 2024
Phase:
Study type: Observational [Patient Registry]

Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, this treatment will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment. Most assessment tools are however not capable of capturing the full range or therapeutic-related evolution of these bowel symptoms. Consequently, the aim is to develop a validated bowel diary for diagnosing and evaluation of all bowel symptoms.

NCT ID: NCT06271629 Completed - Rectal Cancer Clinical Trials

Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients

Start date: February 26, 2022
Phase:
Study type: Observational

The preservation surgery of the anal sphincter has become a standard procedure for the treatment of rectal cancer and is now possible even when the tumor is close to the anus, thanks to the advancement of surgical techniques. This procedure allows patients to avoid a permanent artificial anus and enables them to evacuate through the anus, maintaining the continuity of the intestine, making it a highly preferred surgical option. Additionally, advancements in tumor treatments have led to improved long-term survival rates. However, this anal sphincter preservation surgery inevitably can cause functional abnormalities in the rectum, and around 90% of patients experience changes in bowel habits after surgery. The characteristic symptoms occurring after rectal cancer surgery, such as diarrhea, urgency of bowel movements, frequent bowel movements, and fecal incontinence, are referred to as Anterior Resection Syndrome (ARS). Particularly, symptoms following low anterior resection surgery for lower rectal cancer are termed Low Anterior Resection Syndrome (LARS). These symptoms are most severe immediately after surgery, persisting up to 1-2 years, with some improvement over time. However, in many patients, LARS can remain a lifelong challenge, significantly impacting their quality of life. Currently, there is no definitive method to treat LARS, and symptom management is achieved through empirical treatment methods or medications. Many patients with LARS experience these symptoms predominantly at night, and it is presumed that their sleep quality is severely compromised, significantly affecting their overall quality of life. However, there is a lack of research on the prevalence of such patients and the appropriate treatments for them.

NCT ID: NCT06222255 Recruiting - Rectal Cancer Clinical Trials

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

TraLARS
Start date: December 6, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06162143 Recruiting - Clinical trials for Low Anterior Resection Syndrome

Effect of Gelsectan® in the Treatment of Low Anterior Resection Syndrome

GeLAR
Start date: November 15, 2023
Phase:
Study type: Observational

Low Anterior Resection Syndrome (LARS) is an intestinal disorder affecting patients undergoing rectal resection for rectal cancer. A possible therapeutic option may be Gelsectan®, a class II device used in Irritable Bowel Syndrome (IBS). The aim of this study is to evaluate the efficacy of Gelsectan® in improving the symptoms of LARS.

NCT ID: NCT06059170 Completed - Rectal Cancer Clinical Trials

Rectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life

Start date: March 17, 2017
Phase: N/A
Study type: Interventional

Quality of life and risk factors for developing major LARS are explored. Therapeutic options were explored in the cohort experiencing major LARS

NCT ID: NCT06006260 Recruiting - Rectal Cancer Clinical Trials

Changes of Low Anterior Resection Syndrome and Balance Ability in Patients With Rectal Cancer.

Start date: November 20, 2023
Phase:
Study type: Observational [Patient Registry]

The purposes of this study are to explore the trajectory of symptom distress and balance ability in patients with rectal cancer.

NCT ID: NCT05943444 Recruiting - Quality of Life Clinical Trials

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

Start date: August 8, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05920681 Recruiting - Clinical trials for Low Anterior Resection Syndrome

Transanal Irrigation - Best Treatment Possibility for Low Anterior Resection Syndrome? Multicenter, Randomized Clinical Trial

Start date: June 18, 2023
Phase: N/A
Study type: Interventional

Introduction: About 50% of patients who undergo rectal resection (mostly as a treatment for rectal cancer) suffer from various and partly severe functional problems, despite the preservation of the anal fold. These complaints are summarized as low anterior resection syndrome (LARS). So far, there are no randomized clinical trials that would definitively confirm or deny the hypothesis regarding the most effective treatment for LARS. Objectives: To evaluate whether transanal irrigation improves bowel function and quality of life in patients after rectal resection compared with the best supportive care. Methods and analysis: Patients who have undergone low anterior resection will be approached for this study. During the patient's visit, we will assess their complaints regarding defecation problems, as well as any deterioration in their overall quality of life. To gather this information, we will have the patients fill out questionnaires such as the LARS (Low Anterior Resection Syndrome) and Wexner scale, along with quality of life questionnaires. Questionnaires and scales will be filled out again during the visit every 3 months for 1 year. Discussion: This multicentre, randomized controlled trial will lead to a better understanding of LARS treatment. Moreover, it will be hypothesis generating and inform areas needing future prospective studies.

NCT ID: NCT05907642 Completed - Rectal Cancer Clinical Trials

Effects of Dried Plum (Prune) Intake on the Incidence of Low Anterior Resection Syndrome in Patients With Rectal Cancer

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Colorectal cancer is the third leading cause of cancer death and the fourth most commonly diagnosed cancer in the world. The importance of improving the quality of life of patients after colorectal cancer surgery has been gradually emphasized as the survival period after treatment increases. Especially, patients who underwent rectal cancer surgery experience complex bowel movement abnormalities called 'lower anterior resection syndrome' such as urgency, tenesmus, frequent stool passing, which severely degrades the quality of life after surgery. To manage these symptoms, several treatment modalities including medication, neurostimulation, or biofeedback have been tried, but they are not fully effective. Therefore, we designed this clinical trial to examine the effects of dietary supplementation of the fruit, 'Prune', on improving bowel function after anterior resection rectal cancer surgery. Prune is a dried fruit made from American plums with no seeds, and popular in the worldwide for its sweet and sour flavor and texture. In particular, the high content of sorbitol and dietary fiber softens the stool and improves the overall intestinal function, showing an excellent effect on alleviating constipation symptoms, which has been well studied in several clinical trials. This study is going to be performed on patients under the age of 65 with primary rectal cancer and rectosigmoid colon cancer who underwent low anterior resection (LAR) exclusive of neoadjuvant chemoradiotherapy. Patients who are treated preoperatively with metallic stent insertion will be excluded. Those who have fruit allergy, diabetes, or chronic constipation will also be excluded. Subjects will be randomly assigned to treatment (Prune) or control group (No-prune) immediately after the surgery. Subjects who are assigned to the treatment group consume a total of 100 g of prune per day and the subjects assigned to the control group are allowed to have a normal meal without prune for 18 days. All subjects should fulfill the LAR syndrome questionnaire, The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-c30), and the defecation habit questionnaire on the day before the surgery and the postoperative day 21. And the subjects also fulfill the defecation diary till the postoperative day 21. The primary endpoint is the incidence of LAR syndrome. The secondary endpoint was the score of EORTC QLQ-C30, defecation habit questionnaire. Prune intake is less costly than conventional medical treatments for improving bowel function, and it is expected to show high compliance for patients due to the ease of application. Furthermore, if this study demonstrates that prune intake improves the symptoms of LAR syndrome and quality of life after rectal cancer surgery, the ingredients and components of prune could be used to develop new drugs for alleviating the symptoms of LAR syndrome.

NCT ID: NCT05682157 Recruiting - Clinical trials for Low Anterior Resection Syndrome

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

Start date: March 21, 2023
Phase: N/A
Study type: Interventional

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.