Pilonidal Sinus DiseasePKUPH-PS01NCT07855107
VAAPS Combined With Loose Seton Drainage for Postoperative Self-Care: A Prospective Single-Arm Cohort Study
A study testing VAAPS with Loose Seton Drainage in people with Pilonidal Sinus Disease, run by Peking University People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Sinus Disease
- What is being tested?
- VAAPS with Loose Seton Drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Bozhi Hu, M.D., 0086-18811783528, hbz0411@bjmu.edu.cn
Bozhi Hu, M.D., 0086-17812299283, hbz0411@pku.edu.cn
About this study
Official title: Video-Assisted Ablation of Pilonidal Sinus (VAAPS) Combined With Loose Seton Drainage for Postoperative Self-Care: A Prospective Single-Arm Cohort Study
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.
Read the detailed description
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.
- Conditions
- Pilonidal Sinus Disease
- Being tested
- VAAPS with Loose Seton Drainage
- Keywords
- VAAPS, Pilonidal Sinus
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAAPS with Loose Seton DrainageProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: VAAPS with Loose Seton Drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From surgery date until return to normal work or study(assessed at postoperative day 1, weeks 1, 2, 4, 6).
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.
Measured: From surgery date until complete wound epithelialization (assessed at postoperative weeks 1, 2, 4, 6, and months 3, 6).
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.
Measured: Postoperative 6 hours, day 1, week 1, week 2, week 4, and week 6
Secondary outcomes (3)
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.
Measured: Postoperative months 3, 6, 12, and 36 (1-year and 3-year recurrence rates reported)
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.
Measured: Postoperative months 3 and 12
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.
Measured: Postoperative month 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Sep 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pilonidal Sinus DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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 1/2/4/6, months 3/6/12, and 36) to describe wound healing, pain, time off work, and recurrence in this patient population.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bozhi Hu, Peking University People's Hospital
- Investigators
- Bozhi Hu, M.D., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855107
- Sponsor's protocol ID
- 2026PHB630
- Acronym
- PKUPH-PS01
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single-center observational study with a relatively small sample size (approximately 50 participants). The informed consent form approved by the institutional ethics committee does not include provisions for sharing individual participant data with external researchers. Additionally, all participants are Chinese patients, and their clinical and follow-up data are stored within the hospital's secure electronic medical record system under Chinese data protection regulations, which restrict cross-border data transfer. De-identified aggregate data and study results will be published in peer-reviewed journals, but individual participant data will not be shared publicly or made available to external researchers.
Publications
Milone M, Di Minno MN, Bianco P, Coretti G, Musella M, Milone F. Pilonidal sinus surgery: could we predict postoperative complications? Int Wound J. 2016 Jun;13(3):349-53. doi: 10.1111/iwj.12310. Epub 2014 Jun 3.
PubMed 24894163Doll D. 5- and 10-year recurrence rate is the new gold standard in pilonidal sinus surgery benchmarking. Med Princ Pract. 2010;19(3):216-7. doi: 10.1159/000285292. Epub 2010 Mar 29. No abstract available.
PubMed 20357506Meinero P, Gasloli G, Giani F, et al. Endoscopic pilonidal sinus treatment: a multicentric prospective study. Tech Coloproctol. 2016;20(11):747-752.
Sekhon Inderjit Singh HK, Meinero P, Campanile FC, Quddus A, Rajaganeshan R, Warusavitarne J, Dotlacil V, Bhargava A, Giordano P, Pini Prato A, Shatkar V, Jalali P, Halahakoon VC, Gallo G, Milone M, Mantoo S, Leo CA, Esposito C, Farghaly M, Arulampalam T, Pawa N. The application of EPSiT in pilonidal sinus disease: an international Delphi consensus study endorsed by the Association of Laparoscopic Surgeons of Great Britain and Ireland (ALSGBI). Tech Coloproctol. 2025 Jul 30;29(1):155. doi: 10.1007/s10151-025-03191-7.
PubMed 40736584Milone M, Velotti N, Manigrasso M, Vertaldi S, Di Lauro K, De Simone G, Cirillo V, Maione F, Gennarelli N, Sosa Fernandez LM, De Palma GD. Long-term results of a randomized clinical trial comparing endoscopic versus conventional treatment of pilonidal sinus. Int J Surg. 2020 Feb;74:81-85. doi: 10.1016/j.ijsu.2019.12.033. Epub 2020 Jan 9.
PubMed 31926328Milone M, Fernandez LM, Musella M, Milone F. Safety and Efficacy of Minimally Invasive Video-Assisted Ablation of Pilonidal Sinus: A Randomized Clinical Trial. JAMA Surg. 2016 Jun 1;151(6):547-53. doi: 10.1001/jamasurg.2015.5233.
PubMed 26819186Milone M, Musella M, Di Spiezio Sardo A, Bifulco G, Salvatore G, Sosa Fernandez LM, Bianco P, Zizolfi B, Nappi C, Milone F. Video-assisted ablation of pilonidal sinus: a new minimally invasive treatment--a pilot study. Surgery. 2014 Mar;155(3):562-6. doi: 10.1016/j.surg.2013.08.021. Epub 2013 Oct 25.
PubMed 24300343Al-Khamis A, McCallum I, King PM, Bruce J. Healing by primary versus secondary intention after surgical treatment for pilonidal sinus. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD006213. doi: 10.1002/14651858.CD006213.pub3.
PubMed 20091589Steele SR, Perry WB, Mills S, Buie WD; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of pilonidal disease. Dis Colon Rectum. 2013 Sep;56(9):1021-7. doi: 10.1097/DCR.0b013e31829d2616. No abstract available.
PubMed 23929010Enriquez-Navascues JM, Emparanza JI, Alkorta M, Placer C. Meta-analysis of randomized controlled trials comparing different techniques with primary closure for chronic pilonidal sinus. Tech Coloproctol. 2014 Oct;18(10):863-72. doi: 10.1007/s10151-014-1149-5. Epub 2014 Apr 30.
PubMed 24845110Allen-Mersh TG. Pilonidal sinus: finding the right track for treatment. Br J Surg. 1990 Feb;77(2):123-32. doi: 10.1002/bjs.1800770203.
PubMed 2180534Sondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. doi: 10.1007/BF00337585.
PubMed 7745322McCallum IJ, King PM, Bruce J. Healing by primary closure versus open healing after surgery for pilonidal sinus: systematic review and meta-analysis. BMJ. 2008 Apr 19;336(7649):868-71. doi: 10.1136/bmj.39517.808160.BE. Epub 2008 Apr 7.
PubMed 18390914
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-Assisted Ablation of Pilonidal Sinus (VAAPS) Combined With Loose Seton Drainage for Postoperative Self-Care: A Prospective Single-Arm Cohort Study
- ClinicalTrials.gov ID
- NCT07855107
- Acronym / sponsor ID
- PKUPH-PS01 / 2026PHB630
- Conditions
- Pilonidal Sinus Disease
- Keywords
- VAAPS, Pilonidal Sinus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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 1/2/4/6, months 3/6/12, and 36) to describe wound healing, pain, time off work, and recurrence in this patient population.
| Arm | Type | Receives |
|---|---|---|
| VAAPS with Loose Seton Drainage | Experimental | Procedure: VAAPS with Loose Seton DrainageAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAAPS with Loose Seton DrainageVideo-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. | Procedure or surgery | VAAPS with Loose Seton Drainage |
Primary outcome
Time off work after surgery
Time frame: From surgery date until return to normal work or study(assessed at postoperative day 1, weeks 1, 2, 4, 6).
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.
Time to complete wound healing after surgery
Time frame: From surgery date until complete wound epithelialization (assessed at postoperative weeks 1, 2, 4, 6, and months 3, 6).
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.
Postoperative pain score (VAS) after surgery
Time frame: Postoperative 6 hours, day 1, week 1, week 2, week 4, and week 6
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.
3 secondary outcomes
Recurrence rate
Time frame: Postoperative months 3, 6, 12, and 36 (1-year and 3-year recurrence rates reported)
Patient Satisfaction Score (PSS)
Time frame: Postoperative months 3 and 12
Cosmetic outcome assessed by Wound Evaluation Scale
Time frame: Postoperative month 6 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Results publication: PubMed 24894163Milone M, Di Minno MN, Bianco P, Coretti G, Musella M, Milone F. Pilonidal sinus surgery: could we predict postoperative complications? Int Wound J. 2016 Jun;13(3):349-53. doi: 10.1111/iwj.12310. Epub 2014 Jun 3.
- Results publication: PubMed 20357506Doll D. 5- and 10-year recurrence rate is the new gold standard in pilonidal sinus surgery benchmarking. Med Princ Pract. 2010;19(3):216-7. doi: 10.1159/000285292. Epub 2010 Mar 29. No abstract available.
- Results publicationMeinero P, Gasloli G, Giani F, et al. Endoscopic pilonidal sinus treatment: a multicentric prospective study. Tech Coloproctol. 2016;20(11):747-752.
- Results publication: PubMed 40736584Sekhon Inderjit Singh HK, Meinero P, Campanile FC, Quddus A, Rajaganeshan R, Warusavitarne J, Dotlacil V, Bhargava A, Giordano P, Pini Prato A, Shatkar V, Jalali P, Halahakoon VC, Gallo G, Milone M, Mantoo S, Leo CA, Esposito C, Farghaly M, Arulampalam T, Pawa N. The application of EPSiT in pilonidal sinus disease: an international Delphi consensus study endorsed by the Association of Laparoscopic Surgeons of Great Britain and Ireland (ALSGBI). Tech Coloproctol. 2025 Jul 30;29(1):155. doi: 10.1007/s10151-025-03191-7.
- Results publication: PubMed 31926328Milone M, Velotti N, Manigrasso M, Vertaldi S, Di Lauro K, De Simone G, Cirillo V, Maione F, Gennarelli N, Sosa Fernandez LM, De Palma GD. Long-term results of a randomized clinical trial comparing endoscopic versus conventional treatment of pilonidal sinus. Int J Surg. 2020 Feb;74:81-85. doi: 10.1016/j.ijsu.2019.12.033. Epub 2020 Jan 9.
- Results publication: PubMed 26819186Milone M, Fernandez LM, Musella M, Milone F. Safety and Efficacy of Minimally Invasive Video-Assisted Ablation of Pilonidal Sinus: A Randomized Clinical Trial. JAMA Surg. 2016 Jun 1;151(6):547-53. doi: 10.1001/jamasurg.2015.5233.
- Results publication: PubMed 24300343Milone M, Musella M, Di Spiezio Sardo A, Bifulco G, Salvatore G, Sosa Fernandez LM, Bianco P, Zizolfi B, Nappi C, Milone F. Video-assisted ablation of pilonidal sinus: a new minimally invasive treatment--a pilot study. Surgery. 2014 Mar;155(3):562-6. doi: 10.1016/j.surg.2013.08.021. Epub 2013 Oct 25.
- Results publication: PubMed 20091589Al-Khamis A, McCallum I, King PM, Bruce J. Healing by primary versus secondary intention after surgical treatment for pilonidal sinus. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD006213. doi: 10.1002/14651858.CD006213.pub3.
- Results publication: PubMed 23929010Steele SR, Perry WB, Mills S, Buie WD; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of pilonidal disease. Dis Colon Rectum. 2013 Sep;56(9):1021-7. doi: 10.1097/DCR.0b013e31829d2616. No abstract available.
- Results publication: PubMed 24845110Enriquez-Navascues JM, Emparanza JI, Alkorta M, Placer C. Meta-analysis of randomized controlled trials comparing different techniques with primary closure for chronic pilonidal sinus. Tech Coloproctol. 2014 Oct;18(10):863-72. doi: 10.1007/s10151-014-1149-5. Epub 2014 Apr 30.
- Results publication: PubMed 2180534Allen-Mersh TG. Pilonidal sinus: finding the right track for treatment. Br J Surg. 1990 Feb;77(2):123-32. doi: 10.1002/bjs.1800770203.
- Results publication: PubMed 7745322Sondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. doi: 10.1007/BF00337585.
- Individual participant dataSharing planned: No. This is a single-center observational study with a relatively small sample size (approximately 50 participants). The informed consent form approved by the institutional ethics committee does not include provisions for sharing individual participant data with external researchers. Additionally, all participants are Chinese patients, and their clinical and follow-up data are stored within the hospital's secure electronic medical record system under Chinese data protection regulations, which restrict cross-border data transfer. De-identified aggregate data and study results will be published in peer-reviewed journals, but individual participant data will not be shared publicly or made available to external researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bozhi Hu, M.D. principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VAAPS with Loose Seton Drainage in people with Pilonidal Sinus Disease, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bozhi Hu, M.D. (0086-18811783528, hbz0411@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time off work after surgery (time frame: From surgery date until return to normal work or study(assessed at postoperative day 1, weeks 1, 2, 4, 6).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07855107, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.