Pediatric Pilonidal Sinus Surgical Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorZeliha Alicikus
About this trial
The aim of study to evaluate four different treatment options for pilonidal sinus disease in a randomized controlled trial to find the most suitable treatment option.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
having sacrococcygeal pilonidal sinus disease
written informed (family) consent were eligible for inclusion in this trial
Disqualifiers
Being over 18 years old or under 12 years old
recurrent sacrococcygeal pilonidal sinus disease
Trial design
Design model
Parallel
Treatments tested in this trial
Crystallized Phenol Applied
Procedure/Surgeryfour different surgical methods for the treatment of sacrococcygeal pilonidal sinus
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Crystallized Phenol Applied Group (Group P) n:21Active comparator 1 intervention
Group B: Endoscopy Group (Group EPSiT) n:22Active comparator 1 intervention
Group C: Limberg Flap Group (Group L) n:23Active comparator 1 intervention
Group D: Modified Limberg Flap Group (Group ML) n:22Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
complications
Recurrence
Time frame
30 days2
pain score
VAS score under 4,VAS score above 4
Time frame
24 hoursSecondary outcomes
1
sinus volume measurement
USG guided
Time frame
24 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zeliha Alicikus
Lead sponsor
Umraniye Education and Research Hospital
Sponsor institution
Source ClinicalTrials.gov