رادار التجارب AI | ||
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حالة التجربة السريرية NCT07427927 (PROCTO-CLUSTER) لـ Hemorrhoid، Hemorrhoid Prolapse هي نشط (لا يقبل مشاركين جدد). اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
Data-driven Clustering in Hemorrhoid Surgery: Retrospective Monocentric Study for the Identification of Clinical Phenotypes (PROCTO-CLUSTER) ١٠٠ تعلم الآلة رصدية شخصي
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07427927 (PROCTO-CLUSTER) هي دراسة رصدية لـHemorrhoid، Hemorrhoid Prolapse وهي نشط (لا يقبل مشاركين جدد). بدأت في ٢٩ جمادى الأولى ١٤٤٦ هـ مع خطة لتجنيد ١٠٠ مشاركًا. يقودها IRCCS Policlinico S. Donato، ومن المتوقع اكتمالها بحلول ١٣ شوال ١٤٤٧ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٦ رمضان ١٤٤٧ هـ.
الملخص
This retrospective, single-center observational study will use routinely collected perioperative data from adults undergoing surgery for symptomatic hemorrhoidal disease to identify data-driven clinical phenotypes. Unsupervised machine learning will be applied to characterize clusters of patients based on demographic, clinical, anatomical, and surgical variables. The study will explore whether the resulting phenotype...عرض المزيد
وصف مفصل
Hemorrhoidal disease presents with heterogeneous symptom patterns, anatomical findings, and operative strategies that are not fully captured by traditional degree-based classifications. This study aims to identify latent, clinically interpretable phenotypes among surgical patients using a fully unsupervised machine learning pipeline applied to routinely collected perioperative data from a high-volume tertiary referra...عرض المزيد
العنوان الرسمي
Data-driven Clustering in Hemorrhoid Surgery: Retrospective Monocentric Study for the Identification of Clinical Phenotypes
الحالات الطبية
HemorrhoidHemorrhoid Prolapseالمنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:- Bernabé-Díaz JA, Franco M, Vivo JM, Fernández-Breis JT. Optimizing clustering-based analytical methods with trimmed and sparse clustering. Computers in Biology and Medicine. 2025;194:110436. doi:10.1016/j.compbiomed.2025.110436
- Xiao C, Hong S, Huang W. Optimizing graph layout by t-SNE perplexity estimation. Int J Data Sci Anal. 2023;15(2):159...
معرّفات دراسة أخرى
- PROCTO-CLUSTER
- CET 18-2026
NCT معرّف
تاريخ البدء (فعلي)
2024-12-01
آخر تحديث مُنشور
2026-02-23
تاريخ الاكتمال (المقدر)
2026-04
عدد المشاركين المخطط لهم
١٠٠
نوع الدراسة
رصدية
الحالة
نشط (لا يقبل مشاركين جدد)
الكلمات الرئيسية
Hemorrhoidal Disease
Unsupervised Machine Learning
Unsupervised Machine Learning
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
patients who underwent surgery for symptomatic hemorrhoidal disease Consecutive patients who underwent surgery for symptomatic hemorrhoidal disease at IRCCS Policlinico San Donato between December 2024 and June 2025. Consecutive enrollment was chosen to minimize selection bias and to represent the full spectrum of disease severity in the surgical setting.
Inclusion criteria Age ≥ 18 years Clinical and/or intraoperative diagnosis of symptomatic hemorrhoidal disease Availability of co...عرض المزيد | Any surgical procedure for hemorrhoidal disease standard hemorrhoidectomy, advanced hemorrhoidectomy, prolapsectomy, Doppler-guided procedures, or combined techniques |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Internal validity of the unsupervised clustering solution (silhouette coefficient) | Silhouette coefficient of the final k-means clustering solution derived from t-SNE-reduced perioperative data. The silhouette coefficient will be used as the primary internal validity metric to quantify cluster cohesion and separation for the selected number of clusters. | From completion of dataset extraction/cleaning through completion of clustering analysis (retrospective analysis of surgeries performed December 2024 to June 2025) |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Cluster stability and reproducibility across model runs | Stability of cluster assignments across multiple random seeds and t-SNE parameter settings (including perplexity), summarized by reproducibility/consistency of membership and stability of internal validity metrics across runs. | From completion of dataset extraction/cleaning through completion of clustering robustness analyses (retrospective analysis of surgeries performed December 2024 to June 2025) |
Operative duration (proxy of operative complexity) | Operative duration (minutes) recorded in the operative report/perioperative database; compared across identified phenotypes. | Intraoperative (day of surgery) |
Postoperative pain intensity | Pain intensity as documented in routine postoperative records/follow-up notes (e.g., numeric rating scale when available or clinician-documented pain status), analyzed as pain trajectory/pattern across early and intermediate follow-up and compared across clusters. | From surgery to 6 month postoperatively |
Postoperative complications (Clavien-Dindo classification) | Any postoperative complication recorded in routine follow-up, graded according to the Clavien-Dindo system; complication rates and severity compared across clusters. | From surgery to 1 month postoperatively (early complications) and up to 6 months postoperatively (late complications) |
Time to return to routine activities | Time to return to routine activities/work when documented in follow-up notes; compared across phenotypes. | From surgery to 1 month postoperatively |
Recurrence | Recurrence patterns or persistence/return of hemorrhoid-related symptoms (e.g., bleeding/prolapse/other symptoms) as documented in routine follow-up and need for re-evaluation or additional intervention; compared across clusters. | 1 month and 6 months postoperatively |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- Age ≥ 18 years
- Clinical and/or intraoperative diagnosis of symptomatic hemorrhoidal disease
- Incomplete or missing clinical data
- Presence of anorectal neoplastic conditions (e.g., anal or rectal carcinoma)
- Anorectal surgery within the previous 6 months (to avoid confounding effects on symptoms and anatomy)
IRCCS Policlinico S. Donatoلا توجد بيانات اتصال.
1 مواقع الدراسة في 1 بلدان
Milan
IRCCS Policlinico San Donato, San Donato Milanese, Milan, 20097, Italy