MIPE for Pilonidal Disease

NCT03772873 | Active Not Recruiting

• 1 other identifier: 18-0937-CCMC
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 10

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (6)

• Recurrent disease within 24 months of index surgery

  24 months

• Recurrent disease within 5 years of index surgery

  5 years

• Return to school or work post procedure

  2 months

• Post operative surgical site infection

  2 months

• Requirement for hospital stay

  1 week

Study Arms (2)

MIPE

Patients undergoing minimally invasive pilonidal excision with trephination.

Procedure: minimally invasive pilonidal excision

Other

Patients undergoing a different procedure for pilonidal disease.

Interventions

minimally invasive pilonidal excision PROCEDURE

MIPE procedure with trephine excision of pits and sinuses

Also known as: Gips procedure

MIPE

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children presenting to clinics with symptomatic pilonidal disease and recommended for surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead
• Pediatric Surgical Research Collaborative: collaborator

Study Sites (10)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Advocate Health Center

Park Ridge, Illinois, 60068, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Cohen Children's Medical Center

New Hyde Park, New York, 11040, United States

Location

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

Location

Lehigh Valley Reilly Children's Hospital

Allentown, Pennsylvania, 18104, United States

Location

LeBonheur Children's Hospital

Memphis, Tennessee, 38105, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (4)

• Elalfy 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 BACKGROUND

• Speter 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 BACKGROUND

• Gips 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 BACKGROUND

• Holmebakk T, Nesbakken A. Surgery for pilonidal disease. Scand J Surg. 2005;94(1):43-6. doi: 10.1177/145749690509400111.

  PMID: 15865116 BACKGROUND

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Study Officials

• Charlotte Kvasnovsky, MD, PhD, MPH

  Northwell Health

  PRINCIPAL INVESTIGATOR

• Abdulraouf Lamoshi, MD

  Northwell Health

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 11, 2018
• Study Start: January 1, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 17, 2022

Record last verified: 2022-11

Locations

US (10)