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Low Anterior Resection Syndrome clinical trials

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NCT ID: NCT06359730 Completed - Colorectal Cancer Clinical Trials

Incidence and Risk Factors of Low Anterior Resection Syndrome

Start date: December 1, 2017
Phase:
Study type: Observational

Sphincter sparing surgery is oftentimes associated with bowel dysfunction complaints, namely the low anterior resection syndrome (LARS). The LARS questionnaire is widely used to assess this syndrome. With advances in colorectal surgery, sparing sphincter surgeries are gaining popularity. But symptoms after surgery can affect the quality of life which has psychomotor effects. Low anterior resection syndrome score is a worldwide known questionnaire. Many countries have accredited validation and translation of this questionnaire, but to our knowledge; it is the first time in Egypt.

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: 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: 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: NCT05605600 Completed - Clinical trials for Low Anterior Resection Syndrome

Translation of the International Consensus Definition of LARS Into a Bowl Dysfunction Severity Scoring Tool (New LARS Score)

Start date: October 3, 2022
Phase:
Study type: Observational

The purpose of this study is to develop a new severity scoring tool for Low Anterior Resection Syndrome (LARS) drawing on the international consensus criteria for LARS as well as opinions of patients with lived-experience of LARS.

NCT ID: NCT05129215 Completed - Rectal Cancer Clinical Trials

Development and Validation of The Post-RT LARS Prediction Model (PORTLARS)

PORTLARS
Start date: March 6, 2020
Phase:
Study type: Observational

Bowel dysfunction is common after a restorative rectal cancer resection. Neoadjuvant radiotherapy is an influential factor that impairs bowel function and quality of life. However, almost half patients who have received primary surgery with preoperative radiotherapy are able to restore a good or moderate bowel function in the long term. This multicenter observational study aims to identify the risk factors of severe bowel dysfunction after rectal cancer resection and neoadjuvant radiotherapy, in accordance with the LARS score, and to build a model that predicts long-term major LARS in the early stage of follow-up. Development and validation cohorts are enrolled from tertiary hospitals in China.

NCT ID: NCT05020132 Completed - Clinical trials for Low Anterior Resection Syndrome

Bowel Dysfunction After Rectal Cancer Treatment

Start date: November 1, 2015
Phase:
Study type: Observational [Patient Registry]

Bowel dysfunction after rectal cancer treatment may significantly affect the quality of life. Our study aimed to estimate the incidence and characterize the Low Anterior Resection Syndrome(LARS). We performed a prospective evaluation of patients treated with anterior resection for rectal cancer at two hospitals. Assessment was performed at baseline, after neoadjuvant treatment, and 1, 6 and 12 months after bowel transit reconstruction using the following scores: Bristol scale, LARS score, MSK-BFI, FIQL, EORTC-QLQ30 and a visual analogue scale.

NCT ID: NCT05016583 Completed - Clinical trials for Low Anterior Resection Syndrome

Paula Method of Exercises in Patients With LARS Syndrome

Start date: October 28, 2021
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 feasibility of the Paula Method of exercises in patients post sphincter sparing rectal resection surgery with LARS Syndrome.

NCT ID: NCT04896879 Completed - Rectal Cancer Clinical Trials

Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS

Start date: November 22, 2016
Phase:
Study type: Observational

Exploration of the experiences and needs of patients with the low anterior resection syndrome, their informal caregiver and health care professionals. This is a qualitative study where semi-structured interviews will be conducted with patients and informal caregivers. next to that focus groups will be performed with healthcare professionals from different professions.

NCT ID: NCT04591821 Completed - Rectal Cancer Clinical Trials

Bowel Dysfunction 3 Years After Anterior Resection a in a Swedish National Cohort

Start date: February 15, 2018
Phase:
Study type: Observational

The primary objectives are to evaluate the prevalence of LARS and Quality of Life in rectal cancer patients 3 years after anterior resection, to investigate if anastomotic technique is a risk factor for major LARS and to study the prevalence of colostomy 3 years after anterior resection and evaluate stoma function according to the stoma scale in EORTC QLQ-CR29.