Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus
NCT ID: NCT03271996
Last Updated: 2017-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
60 participants
INTERVENTIONAL
2012-04-30
2017-06-30
Brief Summary
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Detailed Description
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Group A: excision and paramedian closure according to modified Karydakis technique
Group B: removal / fistulectomy by scalpels or trephines of primary and drainage orifices, healing of the wound by secondary intention
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Primary closure
Excision of sinus and paramedian closure according to modified Karydakis technique
Primary closure
Asymmetric skin incision and total excision of the lesion with monopolar scalpel. Accurate hemostasis, creation of a cutaneous-subcutaneous flap, primary closure with non-absorbable sutures, optional aspiration drainage.
Fistulectomy
Removal / fistulectomy by scalpels or trephines of primary and drainage orifices and healing of the wound by second intention
Fistulectomy
Evaluation of the cavity using a 0.5-1 mm metal probe which will be inserted into the skin orifice. Excision of the skin around the orifice and debridement/excision of the cavity by monopolar scalpel or Trephines
Interventions
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Primary closure
Asymmetric skin incision and total excision of the lesion with monopolar scalpel. Accurate hemostasis, creation of a cutaneous-subcutaneous flap, primary closure with non-absorbable sutures, optional aspiration drainage.
Fistulectomy
Evaluation of the cavity using a 0.5-1 mm metal probe which will be inserted into the skin orifice. Excision of the skin around the orifice and debridement/excision of the cavity by monopolar scalpel or Trephines
Eligibility Criteria
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Inclusion Criteria
* Signed Informed Consent Form
Exclusion Criteria
* Injuries requiring a closing with rotation flap
16 Years
ALL
No
Sponsors
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Dimitri Christoforidis
OTHER
Responsible Party
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Dimitri Christoforidis
Vice-Chief in Surgery
Locations
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Ospedale Regionale di Lugano
Lugnao, , Switzerland
Countries
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References
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Popeskou SG, Pravini B, Panteleimonitis S, Vajana AFDT, Vanoni A, Schmalzbauer M, Posabella A, Christoforidis D. Conservative Sinusectomy vs. excision and primary off-midline closure for pilonidal disease: a randomized controlled trial. Int J Colorectal Dis. 2020 Jul;35(7):1193-1199. doi: 10.1007/s00384-020-03551-9. Epub 2020 Mar 6.
Other Identifiers
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11-016
Identifier Type: -
Identifier Source: org_study_id
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