[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658591":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":42,"studyPopulation":34,"armGroups":43,"interventions":50,"overallOfficials":55,"centralContacts":59,"locations":67,"responsibleParty":86,"collaborators":34,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":34,"enrollmentInfo":98,"targetDuration":34,"studyType":101,"phases":102,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":69,"whyStopped":34,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":34},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Time off work after surgery","Number of days from the date of surgery until the patient returns to normal work or study. Recovery to work is defined as daily activities without significant limitation: no pain at rest or with activity, no pain while walking or sitting, and self-dressing changes no more than twice per day. This measures the primary short-term functional outcome of postoperative self-care after VAAPS combined with loose seton drainage.","From surgery date until return to normal work or study(assessed at postoperative day 1, weeks 1, 2, 4, 6).",{"measure":14,"description":15,"timeFrame":16},"Time to complete wound healing after surgery","Number of days from the date of surgery until the surgical wound is completely epithelialized with no discharge, as assessed by a trained surgeon at follow-up visits. Delayed healing is defined as incomplete healing beyond 6 weeks postoperatively. This measures whether the loose seton technique achieves adequate wound healing in patients performing self-care or local dressing changes without standardized flushing at the operating center.","From surgery date until complete wound epithelialization (assessed at postoperative weeks 1, 2, 4, 6, and months 3, 6).",{"measure":18,"description":19,"timeFrame":20},"Postoperative pain score (VAS) after surgery","Pain assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Patients rate their pain at multiple postoperative time points. Repeated-measures analysis describes the pain trajectory over the early postoperative period. This measures whether the loose seton technique and minimally invasive VAAPS produce tolerable pain during self-care at home.","Postoperative 6 hours, day 1, week 1, week 2, week 4, and week 6",[22,26,30],{"measure":23,"description":24,"timeFrame":25},"Recurrence rate","Recurrence is defined as the appearance of at least one of the following after complete wound healing: physician-diagnosed recurrence, formation of a new sinus tract on examination or imaging, new external openings with hair or purulent discharge, or need for reoperation for recurrent local infection. Recurrence-free survival is estimated using the Kaplan-Meier method. Patients without recurrence at last follow-up are censored at the last follow-up date.","Postoperative months 3, 6, 12, and 36 (1-year and 3-year recurrence rates reported)",{"measure":27,"description":28,"timeFrame":29},"Patient Satisfaction Score (PSS)","Overall patient satisfaction with the surgical outcome is self-reported using the Patient Satisfaction Score (PSS), ranging from 0 (completely dissatisfied) to 10 (completely satisfied). This captures patient-reported experience of the minimally invasive procedure and the feasibility of postoperative self-care at home.","Postoperative months 3 and 12",{"measure":31,"description":32,"timeFrame":33},"Cosmetic outcome assessed by Wound Evaluation Scale","Cosmetic outcome of the sacrococcygeal wound is assessed using the Wound Evaluation Scale (WES), a standardized scoring system that evaluates scar appearance including width, contour, color match, and overall cosmetic appearance. A trained clinician rates the scar at the postoperative follow-up visit.","Postoperative month 6 and 12",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"NA","SINGLE_GROUP","All enrolled participants receive the same intervention: video-assisted ablation of pilonidal sinus (VAAPS) with intraoperative placement of two loose glove-edge seton strips for postoperative drainage. There is no parallel control arm, randomization, or blinded treatment assignment. Outcome data are collected prospectively at predefined postoperative time points (day 1, weeks 1\u002F2\u002F4\u002F6, months 3\u002F6\u002F12, and 36) to describe wound healing, pain, time off work, and recurrence in this patient population.","TREATMENT",{"masking":41,"maskingDescription":34,"whoMasked":34},"NONE","\\*\\*Background and Rationale\\*\\*\n\nPilonidal sinus disease is a chronic inflammatory condition of the sacrococcygeal intergluteal cleft, with an incidence of approximately 26 per 100,000 person-years and a male-to-female ratio of about 2:1. Since Mayo first described the condition in 1833, more than 90 surgical approaches have been reported without a universally accepted gold standard. Traditional excision-based techniques produce large, deep wounds associated with significant postoperative pain, prolonged healing, extended sick leave, and substantial recurrence rates.\n\nVideo-Assisted Ablation of Pilonidal Sinus (VAAPS), first described by Milone et al. in 2014, is a minimally invasive approach in which a sinusoscope is inserted through the external opening to identify side tracts, remove hair, and ablate the tract wall under direct vision. The resulting wound is approximately 5 mm wide and 2 mm deep, healing by secondary intention. A randomized clinical trial published in JAMA Surgery demonstrated that VAAPS significantly reduced time off work (1.6 ± 1.7 vs. 8.2 ± 3.9 days, P \\\u003C 0.001) and postoperative pain compared with conventional excision plus Bascom flap, with similar infection rates and 1-year recurrence. Five-year follow-up confirmed comparable recurrence (24.3% vs. 23.8%) while showing significant advantages in patient satisfaction, cosmesis, and cost-effectiveness. A 2025 European Delphi consensus recommended endoscopic minimally invasive approaches (EPSiT\u002FVAAPS) as the preferred treatment for both primary and recurrent pilonidal sinus.\n\nHowever, the minimally invasive design of VAAPS places stringent demands on postoperative drainage. Because the external wound is tiny, premature closure can trap fluid within the tract, leading to delayed healing or surgical site infection. Standard VAAPS postoperative management requires daily saline flushing of the tract for at least 2 weeks via syringe, with in-person follow-up to assess drainage. This model works well when patients can return to the operating center, but in China, a large proportion of patients travel long distances to specialized centers. At our institution, over 60% of VAAPS patients are from other provinces. Local hospitals often lack experience with VAAPS aftercare, and patients who cannot perform standardized flushing at home face elevated risks of delayed presentation and wound complications.\n\n\\*\\*Intervention Description (Loose Glove-Edge Seton Technique)\\*\\*\n\nTo address this gap, our center developed a loose seton adjunct to standard VAAPS. At the completion of the VAAPS procedure, two thin strips cut from sterile surgical glove edges are loosely looped around the upper and lower sinus openings and secured to the surrounding skin. The strips act as a mechanical stent, continuously maintaining tract patency and preventing premature wound closure while allowing granulation tissue to grow from the tract base. This eliminates the need for daily saline flushing. Patients perform routine dressing changes at a local clinic or at home. The first seton strip is removed at approximately 1 week postoperatively (either at a local hospital or by the patient following written instructions), and the second strip is removed at approximately 3 weeks. Before discharge, experienced wound nurses provide standardized education on dressing technique, seton care, recognition of warning signs, and a 24-hour contact line.\n\n\\*\\*Study Design Rationale\\*\\*\n\nThis is a non-interventional observational study: VAAPS with loose seton is already the standard care for out-of-town patients at our department, and the study does not alter any treatment decisions. The research purpose is to systematically document real-world outcomes of this care model, which currently lacks published evidence. We chose a single-arm design because the seton technique is the established standard for this patient population; a randomized comparison with intensive in-center flushing is neither ethically nor practically feasible given that the majority of our patients cannot travel back for daily care. Historical comparison with published VAAPS cohorts (Milone 2016 JAMA Surg; Meinero 2016 Tech Coloproctol) will provide contextual benchmarks.\n\n\\*\\*Preliminary Experience\\*\\*\n\nOur center has performed 23 VAAPS procedures as of study design. All patients recovered normal daily activities within 5 days. Only 4 patients reported mild, tolerable discomfort; the remaining 19 reported no notable pain. Patient satisfaction was 100%. Of the patients who reached the 6-week healing assessment, all showed complete wound healing. These preliminary observations support the feasibility of the approach and motivated this systematic prospective study.\n\n\\*\\*Study Population and Setting\\*\\*\n\nThis single-center study is conducted in the Department of Gastrointestinal Surgery at Peking University People's Hospital, a tertiary academic medical center in Beijing. The institution performs approximately 80 VAAPS procedures annually, of which 60-70% are out-of-town patients. The enrollment period is September 2026 through December 2028, with long-term follow-up extending through 2031.\n\n\\*\\*Follow-up Methodology\\*\\*\n\nShort-term follow-up occurs at postoperative day 1, weeks 1, 2, 4, and 6. Long-term follow-up occurs at months 3, 6, 12, and 36. For out-of-town patients, telephone and WeChat-based follow-up are the primary modes, with in-person visits encouraged at months 1, 3, 6, 12, and 36 when feasible. Wound healing status is assessed by trained surgeons using standardized criteria.",[44],{"label":45,"type":46,"description":47,"interventionNames":48},"VAAPS with Loose Seton Drainage","EXPERIMENTAL","All enrolled participants receive the same intervention: video-assisted ablation of pilonidal sinus (VAAPS) with intraoperative placement of two loose glove-edge seton strips for postoperative drainage.",[49],"Procedure: VAAPS with Loose Seton Drainage",[51],{"type":52,"name":45,"description":53,"armGroupLabels":54,"otherNames":34},"PROCEDURE","Video-assisted ablation of pilonidal sinus (VAAPS) is performed through the external sinus opening using a sinusoscope to identify side tracts, remove hair, and ablate the tract wall under direct vision, leaving a wound approximately 5 mm wide. At the completion of the procedure, two thin strips cut from sterile surgical glove edges are loosely looped around the upper and lower sinus openings and secured to the surrounding skin to maintain tract patency. No postoperative saline flushing is required. Patients perform routine dressing changes at a local clinic or at home. The first seton strip is removed at approximately 1 week postoperatively, and the second strip is removed at approximately 3 weeks. This loose seton technique prevents premature wound closure and fluid accumulation while allowing granulation tissue to grow from the tract base.",[45],[56],{"name":57,"affiliation":5,"role":58},"Bozhi Hu, M.D.","PRINCIPAL_INVESTIGATOR",[60,64],{"name":57,"role":61,"phone":62,"phoneExt":34,"email":63},"CONTACT","0086-18811783528","hbz0411@bjmu.edu.cn",{"name":57,"role":61,"phone":65,"phoneExt":34,"email":66},"0086-17812299283","hbz0411@pku.edu.cn",[68],{"facility":5,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":76,"coordinates":77},"Point",[78,79],116.39723,39.9075,{"lat":79,"lon":78},[82,83,84],{"name":57,"role":61,"phone":62,"phoneExt":34,"email":63},{"name":57,"role":61,"phone":65,"phoneExt":34,"email":66},{"name":85,"role":58,"phone":34,"phoneExt":34,"email":34},"Bozhi Hu",{"type":58,"investigatorFullName":85,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Dr.","100658591","vaaps-combined-with-loose-seton-drainage-for-postoperative-self-care-a-prospective-single-arm-cohort-study-100658591",false,"NCT07855107","VAAPS Combined With Loose Seton Drainage for Postoperative Self-Care: A Prospective Single-Arm Cohort Study","Video-Assisted Ablation of Pilonidal Sinus (VAAPS) Combined With Loose Seton Drainage for Postoperative Self-Care: A Prospective Single-Arm Cohort Study","PKUPH-PS01","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Clinically diagnosed sacrococcygeal pilonidal sinus by physical examination and pelvic MRI\n* Surgical indication for VAAPS procedure\n* Unable to attend long-term postoperative wound care at the operating center (i.e., out-of-town patients who will return to their local residence for postoperative recovery)\n* American Society of Anesthesiologists (ASA) physical status class I or II\n* Able to understand and provide written informed consent\n* Sufficient clinical records and ability to complete postoperative follow-up\n\nExclusion Criteria:\n\n* Presence of an open sacrococcygeal wound or unhealed wound after incision and drainage that prevent VAAPS surgery.\n* Severe cardiac, pulmonary, hepatic, renal, or other major organ dysfunction, or uncontrolled severe comorbidities\n* Coagulation disorder or ongoing anticoagulation therapy\n* Active infection, immunodeficiency disease, or autoimmune disease\n* Pregnant or breastfeeding women\n* Unable to comply with postoperative follow-up or unable to provide informed consent\n* Other conditions precluding tolerance to general anesthesia or prone positioning","ALL","18 Years",{"count":99,"type":100},50,"ESTIMATED","INTERVENTIONAL",[36],"Pilonidal sinus is a chronic infection of the sacrococcygeal skin that mainly affects young adults. Traditional surgery leaves large wounds requiring weeks of daily dressing changes away from home. Video-Assisted Ablation of Pilonidal Sinus (VAAPS) is a minimally invasive procedure that leaves only a 7-mm wound, but it requires daily saline flushing of the sinus tract and regular follow-up at the operating center. At Peking University People's Hospital, over 60% of VAAPS patients travel from other provinces and cannot return for standardized daily wound care. To address this, we developed a loose glove-edge seton technique: two rubber strips cut from surgical glove edges are loosely tied around the sinus openings during surgery to keep them patent, allowing normal dressing changes at home without flushing. The first strip is removed at 1 week and the second at 3 weeks postoperatively. This is a single-center prospective observational study of 50 out-of-town patients undergoing VAAPS with this seton technique. We will collect pain scores, time off work, wound healing time, complications, and recurrence over 3 years to assess whether self-care after VAAPS with loose seton is safe, effective, and feasible for patients who cannot return to the operating center for routine care.",[105],"Pilonidal Sinus Disease",[107,108],"VAAPS","Pilonidal Sinus","2026-10-02",{"date":111,"type":112},"2026-10-07","ACTUAL",{"date":114,"type":112},"2026-09-01",{"date":116,"type":100},"2031-12-31",{"name":5,"class":6},1]