MIPE for Pilonidal Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03772873|
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : July 22, 2019
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.
|Condition or disease||Intervention/treatment|
|Pilonidal Disease Pilonidal Cyst/Fistula Pilonidal Sinus Without Abscess Pilonidal Cyst Without Abscess Pilonidal Cyst and Sinus Without Abscess Pilonidal Abscess Pilonidal Sinus With Abscess Pilonidal Dimple With Abscess Pilonidal Fistula With Abscess Pilonidal Sinus Infected Pilonidal Cyst With Sinus Pilonidal Cyst and Sinus With Abscess Pilonidal Disease of Natal Cleft Abscess||Procedure: minimally invasive pilonidal excision|
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.
|Study Type :||Observational|
|Estimated Enrollment :||140 participants|
|Official Title:||Minimally Invasive Pilonidal Excision for the Treatment of Pilonidal Disease - A Multi-Center Non-Randomized Controlled Trial|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||November 2025|
Patients undergoing minimally invasive pilonidal excision with trephination.
Procedure: minimally invasive pilonidal excision
MIPE procedure with trephine excision of pits and sinuses
Other Name: Gips procedure
Patients undergoing a different procedure for pilonidal disease.
- Recurrent disease within 6 months of index surgery [ Time Frame: 6 months ]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
- Recurrent disease within 24 months of index surgery [ Time Frame: 24 months ]Requirement for a second operative procedure of any kind for pilonidal disease within 24 months of initial procedure
- Recurrent disease within 5 years of index surgery [ Time Frame: 5 years ]Requirement for a second operative procedure of any kind for pilonidal disease within 5 years of initial procedure
- Return to school or work post procedure [ Time Frame: 2 months ]Return to a full day of school or work following procedure
- Post operative surgical site infection [ Time Frame: 2 months ]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.
- Requirement for hospital stay [ Time Frame: 1 week ]Any overnight stay following surgical procedure will be documented
- Surgeon satisfaction with procedure [ Time Frame: 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772873
|Contact: Charlotte Kvasnovsky, MD, PhD, MPHfirstname.lastname@example.org|
|Contact: Aaron Lipskar, MDemail@example.com|
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital of Chicago||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Julia Grabowski, MD 312-227-4210|
|Contact: Benjamin Many|
|Advocate Health Center||Recruiting|
|Park Ridge, Illinois, United States, 60068|
|Contact: Bethany Slater, MD 847-318-9330|
|United States, Maine|
|Maine Medical Center||Recruiting|
|Portland, Maine, United States, 04102|
|Contact: Chris Turner, MD 207-662-5555|
|United States, Maryland|
|University of Maryland Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Kimberly Lumpkins, MD 410-328-6366|
|United States, New York|
|Cohen Children's Medical Center||Recruiting|
|New Hyde Park, New York, United States, 11040|
|Contact: Charlotte Kvasnovsky, MD|
|Contact: Aaron Lipskar, MD|
|Sub-Investigator: Barrie Rich, MD|
|United States, Ohio|
|Dayton Children's Hospital||Recruiting|
|Dayton, Ohio, United States, 45404|
|Contact: Arturo Aranda, MD 937-641-3000|
|Contact: Karen Herzing, BSN, RN 937-641-3799|
|United States, Texas|
|Texas Children's Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Sara Fallon, MD 832-822-3135|
|Contact: Sohail Shah, MD 8328223135|
|Sub-Investigator: Matthew Lahey|
|Principal Investigator:||Charlotte Kvasnovsky, MD, PhD, MPH||Northwell Health|