Pilonidal Disease Clinical Trial
Official title:
De-roofing and Curettage Versus Wide Local Excision for the Treatment of Acute Pilonidal Abscess: A Randomised Controlled Trial
Pilonidal disease refers to a common disease affecting mostly young males. It may present as
asymptomatic pits, acute and painful abscess formation, or chronic discharging sinuses. There
are many treatment options for the latter two manifestations but broadly speaking the
surgical treatment of acute pilonidal abscess can fall into three categories: (1) incision
and drainage, (2) de-roofing and curettage and (3) wide local excision.
The evidence available for the surgical management of acute pilonidal abscess is limited.
Previous studies have consistently demonstrated that incision and drainage results in high
recurrence rates and should not be considered as the first-line treatment option for the
management of acute pilonidal abscess. However, it is not clear whether abscess de-roofing
with curettage or wide local excision should be considered as the surgical procedure of
choice in acute pilonidal abscess. There has not been a prospective randomised study
comparing abscess de-roofing with curettage and wide local excision for acute pilonidal
abscess. The ideal surgical procedure would be one that results in the lowest rate of abscess
recurrence, treats the underlying pilonidal sinus thereby reducing the need for re-operation
but has acceptable post-operative pain, complications and time to complete wound healing.
Status | Not yet recruiting |
Enrollment | 138 |
Est. completion date | November 2019 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - All patients with acute pilonidal abscess Exclusion Criteria: - Patients under the age of 16 years will be excluded. - Immunocompromised (diabetes mellitus, taking oral steroids or immunosuppressive medication) patients will be excluded. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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London North West Healthcare NHS Trust |
Eryilmaz R, Sahin M, Alimoglu O, Kaya B. [The comparison of incision and drainage with skin excision and curettage in the treatment of acute pilonidal abscess]. Ulus Travma Acil Cerrahi Derg. 2003 Apr;9(2):120-3. Turkish. — View Citation
Fahrni GT, Vuille-Dit-Bille RN, Leu S, Meuli M, Staerkle RF, Fink L, Dinçler S, Muff BS. Five-year Follow-up and Recurrence Rates Following Surgery for Acute and Chronic Pilonidal Disease: A Survey of 421 Cases. Wounds. 2016 Jan;28(1):20-6. — View Citation
Hosseini SV, Bananzadeh AM, Rivaz M, Sabet B, Mosallae M, Pourahmad S, Yarmohammadi H. The comparison between drainage, delayed excision and primary closure with excision and secondary healing in management of pilonidal abscess. Int J Surg. 2006;4(4):228-31. Epub 2006 May 22. — View Citation
Loganathan A, Arsalani Zadeh R, Hartley J. Pilonidal disease: time to reevaluate a common pain in the rear! Dis Colon Rectum. 2012 Apr;55(4):491-3. doi: 10.1097/DCR.0b013e31823fe06c. Review. — View Citation
Vahedian J, Nabavizadeh F, Nakhaee N, Vahedian M, Sadeghpour A. Comparison between drainage and curettage in the treatment of acute pilonidal abscess. Saudi Med J. 2005 Apr;26(4):553-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence of pilonidal abscess | During the follow up period the primary outcome measure will be if the patient develops a (recurrent) pilonidal abscess. This is a clinical diagnosis made by the clinician (General Practitioner or Hospital Doctor) attending to the patient. The definition for recurrent pilonidal abscess is any pilonidal abscess that occurs requiring either antibiotic (oral or intravenous) or surgical treatment. A small amount of discharge that settles on its own without the need for such treatment will not be counted as a recurrence. | 1 year | |
Secondary | Time to complete wound healing | Defined as not requiring any further wound dressings | 4-10 weeks | |
Secondary | Return to work | Number of days until returning to work (if unemployed then number of days until resuming normal daily activities) | 2-8 weeks | |
Secondary | Procedural time | Operative time and total time in theatre | 1 hour | |
Secondary | Wound size at operation | Maximal length and width in cm) | 1 hour | |
Secondary | Wound size over time | Maximal length and width in cm weekly until wound healed | 4-10 weeks | |
Secondary | Post-operative pain scores | Using a visual analogue scale weekly until wound healed | 4-10 weeks | |
Secondary | Patient wound impact questionnaire | Cardiff Wound Impact Questionnaire to be performed on the first and last weekly wound review clinic | 4-10 weeks | |
Secondary | Wound infection rate | Infection during the wound healing phase that requires any form of antibiotic (topical, oral or intravenous) | 4-10 weeks |
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