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Patient-Reported Outcomes Following Loose Seton Material Replacement in Complex Anal Fistula (SETon PROM)

2026年9月10日 更新者：semra demirli atici、Acibadem Kent Hospital

Patient-Reported Outcomes Following Loose Seton Material Replacement in Complex Anal Fistula: Protocol for the SETon PROM Prospective Self-Controlled Cohort Study

This prospective, single-center, self-controlled pilot cohort study evaluates whether loose seton biomaterial is associated with patient-reported outcomes in adults with recurrent or persistent complex cryptoglandular anal fistula.

Participants with an existing polypropylene loose seton who require seton replacement as part of routine clinical management will be prospectively enrolled. The decision to replace the seton will be made by the treating colorectal surgeon independently of study participation. No seton replacement or additional surgical procedure will be performed solely for research purposes.

Patient-reported outcomes will be assessed immediately before replacement while the polypropylene loose seton remains in place and will be reassessed at 4 and 12 weeks after replacement with a braided polyester loose seton. The primary outcome is the within-participant change in disease-specific quality of life measured using the Quality of Life in Patients with Anal Fistula Questionnaire (QoLAF-Q). Secondary outcomes include perianal pain, anal continence, patient comfort, foreign-body awareness, hygiene burden, anal discharge, interference with daily activities, patient satisfaction, analgesic use, and treatment-related adverse events.

The study uses a within-participant design in which each participant serves as their own control. As a pilot study, it will also evaluate recruitment, retention, questionnaire completion, protocol adherence, and outcome variability to inform the design of a future multicenter prospective study.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

The SETon PROM Study is an investigator-initiated, prospective, single-center, self-controlled pilot cohort study designed to investigate the association between loose seton biomaterial and patient-reported outcomes during prolonged treatment of recurrent or persistent complex cryptoglandular anal fistula.

The study will enroll consecutive eligible adults who already have a polypropylene loose seton in situ and for whom replacement of the existing seton with a braided polyester loose seton has been determined to be clinically indicated as part of routine care. The clinical decision to replace the seton will be made before enrollment and independently of participation in the study. The study therefore does not assign participants to a treatment or require seton replacement for research purposes.

Each participant will serve as their own control. Baseline patient-reported outcomes will be collected immediately before seton replacement while the polypropylene seton remains in situ and will reflect the participant's experience during the preceding two weeks. The same outcome measures will subsequently be collected at 4 and 12 weeks after placement of the braided polyester loose seton.

Surgical technique, perioperative management, postoperative instructions, and follow-up procedures will be standardized to reduce variability unrelated to the seton biomaterial. Any additional intraoperative procedures, protocol deviations, complications, unplanned healthcare use, or changes in treatment strategy will be prospectively documented.

The study is intended to generate preliminary estimates of within-participant changes in patient-reported outcomes and to assess the feasibility of this prospective self-controlled design. The findings will be used to inform the methodology and sample-size planning of a future multicenter prospective comparative study.

研究类型

观察性的

注册 (估计的)

50

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。

学习联系方式

学习地点

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

取样方法

非概率样本

研究人群

Consecutive adult patients with recurrent or persistent complex cryptoglandular anal fistula who present to a tertiary referral colorectal surgery center with an existing polypropylene loose seton and for whom replacement with a braided polyester loose seton is clinically indicated as part of routine management will be screened for eligibility. Participants must have clinically stable disease without acute perianal sepsis requiring emergency intervention and must be able to complete patient-reported outcome questionnaires. Eligible patients providing written informed consent will be prospectively enrolled.

描述

Inclusion Criteria:

  • Age 18 years or older
  • Recurrent or persistent complex cryptoglandular anal fistula
  • Existing polypropylene loose seton in situ
  • Clinically indicated replacement of the polypropylene loose seton with a braided polyester loose seton as part of routine clinical management
  • Sufficient previous experience with the polypropylene loose seton to permit baseline assessment of patient-reported outcomes
  • Ability to understand and complete the study questionnaires
  • Provision of written informed consent

Exclusion Criteria:

  • Anal fistula associated with Crohn's disease
  • Anal malignancy
  • Rectovaginal fistula
  • Acute perianal abscess or acute perianal sepsis requiring emergency surgical intervention
  • Cognitive impairment preventing completion of patient-reported outcome questionnaires
  • Inability to complete the study questionnaires
  • Pregnancy

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

队列和干预

团体/队列
干预/治疗
Patients Undergoing Loose Seton Replacement
Adults with recurrent or persistent complex cryptoglandular anal fistula who have an existing polypropylene loose seton and undergo clinically indicated replacement with a braided polyester loose seton as part of routine clinical care. Patient-reported outcomes are assessed immediately before replacement while the polypropylene seton remains in situ and at 4 and 12 weeks after replacement with the braided polyester seton. Each participant serves as their own control.
设备：Loose Seton Biomaterial
Participants are observed during sequential exposure to two loose seton biomaterials. Patient-reported outcomes are assessed while an existing polypropylene loose seton is in situ and again at 4 and 12 weeks after clinically indicated replacement with a braided polyester loose seton. The decision to replace the seton is made by the treating colorectal surgeon as part of routine clinical care and independently of study participation. No seton replacement is performed solely for research purposes.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Disease-Specific Quality of Life Measured by the Quality of Life in Patients with Anal Fistula Questionnaire (QoLAF-Q)
大体时间：Baseline and 12 weeks after loose seton replacement
Within-participant change in disease-specific quality of life from baseline with the polypropylene loose seton in situ to 12 weeks after replacement with the braided polyester loose seton, assessed using the 14-item Quality of Life in Patients with Anal Fistula Questionnaire (QoLAF-Q). The total score ranges from 14 to 70, with higher scores indicating a greater negative impact of anal fistula on quality of life and therefore a worse outcome. The primary outcome will be calculated as the within-participant change in total QoLAF-Q score between baseline and 12 weeks after seton replacement.
Baseline and 12 weeks after loose seton replacement

次要结果测量

结果测量
措施说明
大体时间
Change in Perianal Pain Assessed by the Visual Analogue Scale (VAS)
大体时间：Baseline and 4 and 12 weeks after loose seton replacement
Within-participant change in perianal pain from baseline with the polypropylene loose seton in situ to 4 and 12 weeks after replacement with the braided polyester loose seton, assessed using the 10-cm Visual Analogue Scale (VAS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain severity and therefore a worse outcome.
Baseline and 4 and 12 weeks after loose seton replacement
Change in Anal Continence Assessed by the Wexner Fecal Incontinence Score
大体时间：Baseline, 4 weeks, and 12 weeks after loose seton replacement
Within-participant change in anal continence from baseline with the polypropylene loose seton in situ to 4 and 12 weeks after replacement with the braided polyester loose seton, assessed using the Wexner Fecal Incontinence Score. The total score ranges from 0 to 20, where 0 indicates perfect continence and 20 indicates complete fecal incontinence. Higher scores indicate more severe fecal incontinence and therefore a worse outcome.
Baseline, 4 weeks, and 12 weeks after loose seton replacement
Change in Overall Patient Comfort Assessed Using an Investigator-Defined 5-Point Patient Comfort Rating Scale
大体时间：Baseline, 4 weeks, and 12 weeks after loose seton replacement
Within-participant change in overall comfort associated with the loose seton from baseline with the polypropylene loose seton in situ to 4 and 12 weeks after replacement with the braided polyester loose seton, assessed using an investigator-defined 5-point Patient Comfort Rating Scale. Scores range from 1 to 5: 1, very uncomfortable; 2, uncomfortable; 3, neither uncomfortable nor comfortable; 4, comfortable; and 5, very comfortable. Higher scores indicate greater patient comfort and therefore a better outcome.
Baseline, 4 weeks, and 12 weeks after loose seton replacement
Change in Patient Satisfaction With the Loose Seton Assessed Using an Investigator-Defined 5-Point Patient Satisfaction Rating Scale
大体时间：Baseline, 4 weeks, and 12 weeks after loose seton replacement
Within-participant change in overall satisfaction with the loose seton from baseline with the polypropylene loose seton in situ to 4 and 12 weeks after replacement with the braided polyester loose seton, assessed using an investigator-defined 5-point Patient Satisfaction Rating Scale. Scores range from 1 to 5: 1, very dissatisfied; 2, dissatisfied; 3, neither dissatisfied nor satisfied; 4, satisfied; and 5, very satisfied. Higher scores indicate greater patient satisfaction and therefore a better outcome.
Baseline, 4 weeks, and 12 weeks after loose seton replacement
Patient Preference for Loose Seton Biomaterial Assessed Using an Investigator-Defined Single-Item Preference Questionnaire
大体时间：12 weeks after loose seton replacement
Participant-reported preference after experiencing both the polypropylene and braided polyester loose setons will be assessed using an investigator-defined single-item questionnaire: "Considering your overall experience, which loose seton material would you prefer?" Response options will be: (1) polypropylene loose seton, (2) braided polyester loose seton, and (3) no preference. Results will be reported as the number and percentage of participants selecting each response category. This is a categorical outcome; therefore, no minimum or maximum score or direction of scoring applies.
12 weeks after loose seton replacement
Cumulative Analgesic Consumption Assessed by a Participant-Reported Medication Diary
大体时间：Through 12 weeks after loose seton replacement
Cumulative analgesic consumption after replacement of the polypropylene loose seton with the braided polyester loose seton will be assessed using a participant-reported medication diary. Participants will record the name of each analgesic medication, the dose taken, and the date of administration. The outcome will be expressed as the total number of analgesic doses taken by each participant during the 12-week follow-up period. The minimum possible value is 0 doses, with no predefined maximum. Higher values indicate greater analgesic requirement and therefore a worse outcome.
Through 12 weeks after loose seton replacement
Incidence of Postoperative Complications
大体时间：Through 12 weeks after loose seton replacement
Number and proportion of participants experiencing postoperative complications during follow-up, including local infection and premature seton loss.
Through 12 weeks after loose seton replacement
Incidence of Unplanned Treatment-Related Healthcare Utilization or Reintervention Assessed by Medical Record Review and Participant Interview
大体时间：From loose seton replacement through 12 weeks after replacement
The occurrence of any unplanned treatment-related healthcare utilization or reintervention following loose seton replacement will be assessed through medical record review and structured participant interview. A participant will be classified as having experienced the outcome if at least one of the following occurs during follow-up: an unplanned outpatient visit, emergency department attendance, hospital readmission, or an additional medical, radiological, or surgical intervention related to the loose seton or anal fistula. The outcome will be reported as the number and percentage of participants experiencing at least one event. This is a binary outcome (0 = no event; 1 = one or more events), with a value of 1 indicating a worse outcome.
From loose seton replacement through 12 weeks after replacement

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。

赞助

Acibadem Kent Hospital

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10月1日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2028年2月1日

研究注册日期

首次提交

2026年9月6日

首先提交符合 QC 标准的

2026年9月10日

首次发布 (实际的)

2026年9月14日

研究记录更新

最后更新发布 (实际的)

2026年9月14日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • SETon PROM

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be publicly shared because of participant confidentiality and data protection considerations. Aggregated study results will be reported in scientific publications and presentations.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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