An observational study in Pilonidal Disease, Pilonidal Cyst/Fistula and Pilonidal Sinus Without Abscess, sponsored by Northwell Health. Active, not recruiting at 10 sites in United States. Open to participants aged 2 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-17.
Sponsored by Northwell Health · Observational
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.
Pilonidal disease is an inflammatory and infectious condition most often affecting young adult males. Though the pathogenesis is still debated, it is thought that tears in hair follicles of the natal cleft form small crevices where hairs and debris can collect. Over time, constant friction and stretching from daily movement pulls the debris deeper into the cavity creating a sinus. The patient is susceptible to recurrent infections because of the constant warmth, humidity, and exposure to skin and gut flora in the affected area. The clinical presentation of this condition may be acute or chronic and ranges from small, asymptomatic pits in the skin, to large abscesses with purulent and blood drainage.
Initial treatments for pilonidal disease typically include trials of conservative treatments such as improved personal hygiene with regular shaving or laser hair removal, before surgical interventions are considered. Minimally invasive options include injection of phenol, fibrin glue, cyanoacrylate into the affected areas. For patients failing conservative management, or with extensive disease, surgical management has been the standard of care.
There are a wide variety of surgical techniques for refractory pilonidal disease. These include excision with lay open or primary closure, incision and marsupialization, excision with V-Y, W-, and Z-plasty flap. Other procedures described include rhomboid excision and Limberg flap, and excision with off-midline closure. This lack of standardization suggests a complex problem without optimal treatment. The MIPE procedure with trephine excision of pits and sinuses provides an elegant solution for the majority of patients, maximizing clearance of hair follicles and diseased tissue while minimizing morbidity.
Discrepancies in recurrence rates, lengths of hospital course, time to return to work, and patients' aesthetic satisfaction between the various treatment options has led to great controversy over the best approach. Among the surgical options, some studies have reported shorter operative time, hospital stay, and time for wound healing with the excision with primary closure method, whereas flap techniques generally have a lower incidence of recurrence. However, other studies have shown shorter hospital duration and time to return to work specifically for the Limberg flap in comparison to primary closure. Controversy aside, the various surgical methods prioritize complete excision of diseased tissue at the expense of dissatisfying wound aesthetics.
MIPE with trephination was introduced by Gips et al, as an alternative excision strategy that allows for thorough pilonidal debridement while minimizing the need for general anesthesia, inpatient post-operative care, and disfiguring wound healing. Though there is an increased recurrence rate, this simple outpatient procedure allows for repeat excision at the onset of disease recurrence.
The investigators aim to study the use of this procedure in children and young adults.
109 studies on the registry are indexed under Pilonidal Sinus; 32 are open to participants now.
This study's enrollment of 151 is close to the median of 145 across 37 observational studies indexed under Pilonidal Sinus.
Browse Pilonidal Sinus studies →Northwell Health is the lead sponsor of 475 studies on the registry; 107 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 23 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Children presenting to clinics with symptomatic pilonidal disease and recommended for surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 with significant medical comorbidities, such as cancer, diabetes mellitus, chronic use, and use of therapies, are excluded from the study. Any patient with an will be excluded.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing minimally invasive pilonidal excision with trephination.
Procedure: minimally invasive pilonidal excision
Patients undergoing a different procedure for pilonidal disease.
MIPE procedure with trephine excision of pits and sinuses
Also known as: Gips procedure
Recurrent disease within 6 months of index surgery
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
Time frame: 6 months
Recurrent disease within 24 months of index surgery
Requirement for a second operative procedure of any kind for pilonidal disease within 24 months of initial procedure
Time frame: 24 months
Recurrent disease within 5 years of index surgery
Requirement for a second operative procedure of any kind for pilonidal disease within 5 years of initial procedure
Time frame: 5 years
Return to school or work post procedure
Return to a full day of school or work following procedure
Time frame: 2 months
Post operative surgical site infection
Need for antibiotic therapy. While subjective this at least suggests a concern on the part of a healthcare provider, absent the need for objective measures such as WBC and fever.
Time frame: 2 months
Requirement for hospital stay
Any overnight stay following surgical procedure will be documented
Time frame: 1 week
Surgeon satisfaction with procedure
Surgeon questionnaire at beginning and end of enrollment on experience with procedure. Satisfaction will be measured qualitatively through a questionnaire designed for the study, detailing what procedure(s) the surgeon has performed in the past for pilonidal disease, his/her rationale for that procedure, and interest in MIPE.
Time frame: 6 months
Plan to share: Undecided — Discussing availability of IPD with participating sites.
This study is active, not recruiting, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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