Transanal Irrigation - Best Treatment Possibility for Low Anterior Resection Syndrome? Multicenter, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Proportion of patients for whom best supportive treatment reduced LARS symptom scores
研究概览
简要总结
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.
详细描述
This is a multicenter randomized clinical trial. The main objective of this clinical trial is to evaluate whether transanal irrigation improves bowel function and quality of life in patients following low anterior resection best supportive care. This will be accomplished by recording the patient's complaints (defecation, urination problems, deterioration of quality of life) after the operation, filling the LARS score (3,112), Wexner scale (123), quality of life questionnaires (EORTC CR29 (134) and Measure yourself medical outcomes profile (MYMOP)) (15) with additional questions: Would you advice this treatment to anybody else? Did your quality of live improve? Did the bowl function improve? Are you satisfied with the treatment? Did you expect the treatment would help? These questions will be rated from 0 to 5. All will be filled in again during the visit every 3 months for 12 months.
Study population All patients who developed LARS and meet the inclusion criteria will be offered participation in this clinical trial.
Recruitment Patients who have developed LARS and meet the inclusion criteria will be offered participation in this clinical trial upon consultation with an abdominal surgeon or surgeon at the National Cancer Institute clinic (or any other participating center). The patient will be given time to think as much as necessary, and all questions related to the clinical trial will be answered. The patient's decision to participate or not to participate in the study will not have any effect on his further treatment and or surveillance. Patients who have consented and signed the personal information form and the consent form will be included in the study.
Interventions During the study, transanal irrigations will be used -- which are considered safe procedures that do not pose additional risks to the patient.
TAI (Transanal irrigation):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
During the research, the name and surname of the subject will be replaced by a special code, according to which it will not be possible to determine the identity of the subject. The subject will be randomly assigned a combination of numbers and/or letters, which will not use the patient's name, surname, initials or other personally identifiable information. This code will be used in all study documents except the consent form. If the law does not provide otherwise, only the doctor conducting the study, the research staff will be able to get acquainted with the confidential data revealing the name and surname.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is an adult (≥ 18 years);
- •Agrees to participate in a study;
- •A low anterior resection (robotic, laparoscopic or open) was performed (anastomosis up to 5-7 cm from the anocutaneous line when assessed with a finger or endo(recto)scope);
- •>12 months have passed since the operation or the closure of the ileostomy (if formed);
- •No anastomotic leak or stenosis (assessed clinically, during examination, and/or proctogram);
- •LARS >30 points (major LARS).
排除标准
- •Tumor recurrence/progression
- •Pregnancy
- •Diagnosed with inflammatory bowel disease (ICD codes K50-59).
- •Side-to-end anastomosis
- •Palliative care
- •Will not be able to perform irrigation
结局指标
主要结局
Proportion of patients for whom best supportive treatment reduced LARS symptom scores
时间窗: 1 year
Assess the proportion of patients with best supportive care that reduces the symptoms of LARS.
Proportion of patients for whom transanal irrigation reduced LARS symptom scores
时间窗: 1 year
Assess the proportion of patients with transanal irrigation that reduces the symptoms of LARS.
次要结局
未报告次要终点
研究者
Audrius Dulskas
Surgeon (oncologist)
National Cancer Institute, Lithuania