Clinical trial · Observational
MIPE for Pilonidal Disease
Minimally Invasive Pilonidal Excision for the Treatment of Pilonidal Disease - A Multi-Center Non-Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pilonidal disease often presents as a chronic, relapsing condition. A variety of procedures are used in the management of pilonidal disease, with varying degrees of morbidity, disease-free interval, and long-term success. In patients with new-onset or recurrent pilonidal disease, the investigators aim to address how minimally invasive trephine excision compares to other surgical procedures in terms of short- and long-term clinical outcomes and patient satisfaction. In the absence of a gold standard surgical procedure, surgeon preference will help dictate the management of pilonidal disease. For many surgeons, this means a variation on open excision for pilonidal disease failing conservative management. However, outcomes for minimally invasive pilonidal excision (MIPE) as initially described by Gips and forthcoming Lipskar et al., are likely to alter management of the disease (Gips, 2008). The investigators wish to assess patient and surgeon satisfaction with MIPE, and short-term outcomes.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pilonidal Abscess | — | UNRESOLVED | — |
| Pilonidal Cyst and Sinus With Abscess | — | UNRESOLVED | — |
| Pilonidal Cyst and Sinus Without Abscess | — | UNRESOLVED | — |
| Pilonidal Cyst/Fistula | — | UNRESOLVED | — |
| Pilonidal Cyst Without Abscess | — | UNRESOLVED | — |
| Pilonidal Cyst With Sinus | — | UNRESOLVED | — |
| Pilonidal Dimple With Abscess | — | UNRESOLVED | — |
| Pilonidal Disease | — | UNRESOLVED | — |
| Pilonidal Disease of Natal Cleft Abscess | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| minimally invasive pilonidal excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- MIPE
- description
- Patients undergoing minimally invasive pilonidal excision with trephination.
- interventionNames
- Procedure: minimally invasive pilonidal excision
- label
- Other
- description
- Patients undergoing a different procedure for pilonidal disease.
Primary outcomes (1)
- measure
- Recurrent disease within 6 months of index surgery
- timeFrame
- 6 months
- description
- The primary end-point will be the requirement for a second operative procedure of any kind for pilonidal disease within 6 months of initial procedure
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Patients under the age of 25 with pilonidal disease may be included in the study. Patients with primary pilonidal disease or recurrence of pilonidal disease after previous intervention may be included. Patients with acute pilonidal abscess or active infection may also be included in the study, provided they undergo a procedure more extensive than simple incision and drainage. At our institution, patients with acute abscess may undergo more extensive procedure at their initial operation, at surgeon discretion. Exclusion Criteria: * Patients who undergo simple incision and drainage for pilonidal disease as their index procedure will be excluded from the study, as this is generally a temporizing measure. Patients who undergo wide local excision, or any more complex procedure will be included within the 'standard procedure' arm. Patients who had previously undergone a simple drainage procedure and present for definitive management will be included. Patients with significant medical comorbidities, such as cancer, diabetes mellitus, chronic steroid use, and use of immunosuppressant therapies, are excluded from the study. Any patient with an ASA III or IV will be excluded.
References
Publications (4)
- BACKGROUNDElalfy K, Emile S, Lotfy A, Youssef M, Elfeki H. Bilateral gluteal advancement flap for treatment of recurrent sacrococcygeal pilonidal disease: A prospective cohort study. Int J Surg. 2016 May;29:1-8. doi: 10.1016/j.ijsu.2016.03.006. Epub 2016 Mar 11. PMID 26975846
- BACKGROUNDSpeter C, Zmora O, Nadler R, Shinhar D, Bilik R. Minimal incision as a promising technique for resection of pilonidal sinus in children. J Pediatr Surg. 2017 Sep;52(9):1484-1487. doi: 10.1016/j.jpedsurg.2017.03.040. Epub 2017 Mar 20. PMID 28366559
- BACKGROUNDGips M, Melki Y, Salem L, Weil R, Sulkes J. Minimal surgery for pilonidal disease using trephines: description of a new technique and long-term outcomes in 1,358 patients. Dis Colon Rectum. 2008 Nov;51(11):1656-62; discussion 1662-3. doi: 10.1007/s10350-008-9329-x. Epub 2008 May 31. PMID 18516645
- BACKGROUNDHolmebakk T, Nesbakken A. Surgery for pilonidal disease. Scand J Surg. 2005;94(1):43-6. doi: 10.1177/145749690509400111. PMID 15865116