Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
2026年8月10日 更新者:Hospital Universitari Vall d'Hebron Research Institute
Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome: a Randomized, Multicenter, Prospective, Open-label, Pragmatic Study.
A randomized, prospective, multicenter, open-label, pragmatic pilot study of patients with Low Anterior Resection Syndrome treated early (<120 days after discharge following intestinal bypass reconstruction) with sacral nerve root neuromodulation, compared with another group receiving personalized conservative treatment as performed in routine clinical practice.
研究概览
研究类型
介入性
注册 (估计的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Catalonia
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Barcelona、Catalonia、西班牙、08035
- Vall d'Hebron Barcelona Hospital Campus
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接触:
- Franco Marinello, Dr.
- 电话号码:+34 934896587
- 邮箱:franco.marinello@vallhebron.cat
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Adult patients (18 years of age or older) who are capable of signing the appropriate informed consent form.
- Patients who have undergone an anterior rectal resection for rectal cancer, with an anastomosis, whether or not they have received neoadjuvant therapy, and who have bowel function, either via a direct anastomosis or following reconstruction of a lateral ileostomy.
- Patients who experience more than 6 episodes of urgency and/or incontinence in the following two weeks after the screening visit, as recorded in a daily bowel diary.
- Patients with a LARS score >21 points (major or minor LARS).
- Patients who report at least one symptom and one consequence as defined by the international definition.
Exclusion Criteria:
- Metastatic disease at the time of surgery.
- Need for adjuvant chemotherapy at the time of assessment.
- Active chemotherapy.
- Patients with an ileostomy.
- Intellectual or language-related difficulty in answering the questionnaires.
- Refusal to participate in the study or failure to commit to follow-up visits.
- Patients with contraindications for sacral neuromodulation implantation (those with pacemakers, active infections, or allergies to prosthetic materials).
- Patients with active inflammatory bowel disease at the time of surgery.
- Patients who have undergone other intestinal resections in addition to rectal resection.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Sacral neuromodulation
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Sacral neuromodulation implantation within 120 days from discharge following rectal surgery or bowel reconstruction (ileostomy closure)
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无干预:Personalized conservative treatment
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
To evaluate bowel function in terms of at least a 50% improvement in episodes of urgency and/or incontinence due to LARS, as measured by a two-week bowel diary, following early NMS implantation compared with personalized conservative treatment.
大体时间:6 months
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6 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Assess changes in the fragmentation component of the syndrome as recorded in the patient's daily bowel movement diary.
大体时间:6 months
|
6 months
|
|
Assess changes in stool consistency as recorded in the patient's daily bowel movement diary.
大体时间:6 months
|
6 months
|
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Assess changes in soiling episodes as recorded in the patient's daily bowel movement diary.
大体时间:6 months
|
6 months
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Assess changes in symptoms and outcomes as defined by the International Consensus Definition of LARS.
大体时间:6 months
|
6 months
|
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Assess changes in bowel function in both groups using patient's daily bowel function and quality-of-life scales: the LARS score (Low Anterior Resection Syndrome Score), which divides patients in three groups: 0-20 No LARS; 21-29: Mild LARS; 30-42: Severe
大体时间:6 months
|
6 months
|
|
Assess changes in bowel function in both groups using patient's daily bowel function and quality-of-life scales: the Vaizey score, which measures the presence and severity of incontinence assigning a score from 0 (meaning complete continence) to 24 (mean
大体时间:5 years
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5 years
|
|
Assess changes in bowel function in both groups using patient's daily bowel function and quality-of-life scales: ad hoc scale. The minimum value for the scale is 0 (meaning the worst health the patient can imagine) and the maximum value is 100 (meaning t
大体时间:6 months
|
6 months
|
|
Analyze subjective clinical improvement as assessed by patients using PGI-I scale (Patient Global Impression of Improvement). It consists of the answer to a question choosing one of 7 options from "1=Much better" to "7=Much worst".
大体时间:6 months
|
6 months
|
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Examine changes in urinary and sexual function, analyzed by gender and specific scale. For male, the IIEF-5 (Índice Internacional De Función Erectil) will be used, which assesses erectile dysfunction from 5 (severe) to 25 (healthy). For female, The Rec
大体时间:6 months
|
6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2029年8月1日
研究完成 (估计的)
2030年2月1日
研究注册日期
首次提交
2026年7月27日
首先提交符合 QC 标准的
2026年8月10日
首次发布 (实际的)
2026年8月12日
研究记录更新
最后更新发布 (实际的)
2026年8月12日
上次提交的符合 QC 标准的更新
2026年8月10日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.