Comparison of Karydakis and Limberg Flap Treatment of Pilonidal Sinus in Adolescent. a Prospective, Randomised Study
a Prospective, Randomized, Double-blind Study. comparıson of Karydakis Flap and Limberg Flap Treatment of Pilonidal Sinus in Adolescent. a Prospective, Randomised Study
1 other identifier
interventional
90
1 country
1
Brief Summary
Pilonidal sinus disease (PSD) is a chronic inflammation and infection of the sacrococcygeal region. Produces clinic findings with abscess and discharge in the sacrococcygeal region or painful sinus tract in the natal cleft. Its incidence rate among Turkish servicemen is reported to be 8.8% in a study. Although pilonidal sinus disease is common in men, this is the opposite in adolescence. Because adolescent girls are 2 or 3 times more. Karydakis flap and Limberg flap operations widely preferred in recent years in the surgical treatment of PSD. In our study, we aim to compare these two techniques prospectively and randomly.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 22, 2019
CompletedFirst Submitted
Initial submission to the registry
January 2, 2020
CompletedFirst Posted
Study publicly available on registry
January 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2021
CompletedJuly 9, 2020
July 1, 2020
2 years
January 2, 2020
July 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative recurrence
pain, swelling and redness in examination
1 month
Secondary Outcomes (2)
Postoperative infection
1 week
Postoperative wound dehiscence
1 week
Study Arms (2)
karydakis flap
ACTIVE COMPARATORAn asymmetric elliptical excision is performed, defective tissues between the lower and upper ends are removed until they reach healthy borders. The wound edge is then mobilized and the flap is slid over the corresponding wound edge by suturing to the fascia and the skin to the appropriate wound layers. Thus, the gluteal groove is lateralized. Subcutaneous tissue and skin are closed.
limberg flap
ACTIVE COMPARATORRhomboid excision and pilonidal sinuses together with damaged tissue. On the right side of the patient, the intact skin is shifted to the medial area where the tissues are removed without tension. Thus, the defective part and gluteal groove are corrected.
Interventions
Closure of the defect in pilonidal sinus excision with one of the randomly selected flap methods.
Eligibility Criteria
You may qualify if:
- Pilonidal sinus disease
You may not qualify if:
- Other disease than pilonidal sinus disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kahramanmaras Sutcu Imam University
Kahramanmaraş, Onikisubat, 46050, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ahmet gökhan güler
kahramanmarasSUI
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
January 2, 2020
First Posted
January 3, 2020
Study Start
May 22, 2019
Primary Completion
May 22, 2021
Study Completion
May 22, 2021
Last Updated
July 9, 2020
Record last verified: 2020-07