Video-Assisted Ablation of Pilonidal Sinus (VAAPS) Combined With Loose Seton Drainage for Postoperative Self-Care: A Prospective Single-Arm Cohort Study
| Registry | NCT07855107, acronym PKUPH-PS01 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 50 (Estimated) |
| Sponsor | Peking University People's Hospital (Other) |
| Conditions | Pilonidal Sinus Disease |
| Interventions | VAAPS with Loose Seton Drainage (Procedure) |
| Dates | start 2026-09-01, primary completion 2027-09-30 (estimated), completion 2031-12-31 (estimated), first posted 2026-10-02, last updated 2026-10-07 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Pilonidal Sinus Disease All trials of VAAPS with Loose Seton Drainage
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.
**Background and Rationale**
Pilonidal 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.
Video-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 < 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/VAAPS) as the preferred treatment for both primary and recurrent pilonidal sinus.
However, 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.
**Intervention Description (Loose Glove-Edge Seton Technique)**
To 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.
**Study Design Rationale**
This 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.
**Preliminary Experience**
Our 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.
**Study Population and Setting**
This 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.
**Follow-up Methodology**
Short-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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| VAAPS with Loose Seton Drainage | Experimental | Procedure: VAAPS with Loose Seton Drainage | 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. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Age ≥ 18 years * Clinically diagnosed sacrococcygeal pilonidal sinus by physical examination and pelvic MRI * Surgical indication for VAAPS procedure * 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) * American Society of Anesthesiologists (ASA) physical status class I or II * Able to understand and provide written informed consent * Sufficient clinical records and ability to complete postoperative follow-up Exclusion Criteria: * Presence of an open sacrococcygeal wound or unhealed wound after incision and drainage that prevent VAAPS surgery. * Severe cardiac, pulmonary, hepatic, renal, or other major organ dysfunction, or uncontrolled severe comorbidities * Coagulation disorder or ongoing anticoagulation therapy * Active infection, immunodeficiency disease, or autoimmune disease * Pregnant or breastfeeding women * Unable to comply with postoperative follow-up or unable to provide informed consent * Other conditions precluding tolerance to general anesthesia or prone positioning
| Facility | City | Country | Status |
|---|---|---|---|
| Peking University People's Hospital | Beijing, Beijing Municipality | China | Recruiting |