Patient-Reported Outcomes Following Loose Seton Material Replacement in Complex Anal Fistula (SETon PROM)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Semra Demirli Atici, MD
- 電話番号：9005363624585
- メール：smrdemirli@hotmail.com
研究場所
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Izmir、トルコ（Türkiye）、35630
- Acibadem Kent Hospital
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コンタクト：
- Semra Demirli Atici, MD
- 電話番号：9005363624585
- メール：smrdemirli@hotmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Disease-Specific Quality of Life Measured by the Quality of Life in Patients with Anal Fistula Questionnaire (QoLAF-Q)
時間枠：Baseline and 12 weeks after loose seton replacement
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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.
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Baseline and 12 weeks after loose seton replacement
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in Perianal Pain Assessed by the Visual Analogue Scale (VAS)
時間枠：Baseline and 4 and 12 weeks after loose seton replacement
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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.
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Baseline and 4 and 12 weeks after loose seton replacement
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Change in Anal Continence Assessed by the Wexner Fecal Incontinence Score
時間枠：Baseline, 4 weeks, and 12 weeks after loose seton replacement
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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.
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Baseline, 4 weeks, and 12 weeks after loose seton replacement
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Change in Overall Patient Comfort Assessed Using an Investigator-Defined 5-Point Patient Comfort Rating Scale
時間枠：Baseline, 4 weeks, and 12 weeks after loose seton replacement
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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.
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Baseline, 4 weeks, and 12 weeks after loose seton replacement
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Change in Patient Satisfaction With the Loose Seton Assessed Using an Investigator-Defined 5-Point Patient Satisfaction Rating Scale
時間枠：Baseline, 4 weeks, and 12 weeks after loose seton replacement
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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.
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Baseline, 4 weeks, and 12 weeks after loose seton replacement
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Patient Preference for Loose Seton Biomaterial Assessed Using an Investigator-Defined Single-Item Preference Questionnaire
時間枠：12 weeks after loose seton replacement
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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.
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12 weeks after loose seton replacement
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Cumulative Analgesic Consumption Assessed by a Participant-Reported Medication Diary
時間枠：Through 12 weeks after loose seton replacement
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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.
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Through 12 weeks after loose seton replacement
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Incidence of Postoperative Complications
時間枠：Through 12 weeks after loose seton replacement
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Number and proportion of participants experiencing postoperative complications during follow-up, including local infection and premature seton loss.
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Through 12 weeks after loose seton replacement
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Incidence of Unplanned Treatment-Related Healthcare Utilization or Reintervention Assessed by Medical Record Review and Participant Interview
時間枠：From loose seton replacement through 12 weeks after replacement
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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.
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From loose seton replacement through 12 weeks after replacement
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- SETon PROM
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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