Pediatric Pilonidal Sinus Surgical Treatment

NCT07369921 | Recruiting

• 1 other identifier: Z.AKIŞ
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgery; Pediatric; Pilonidal Sinus

Keywords

Pilonidal Sinus; pediatric surgery

Outcome Measures

Primary Outcomes (2)

• complications

  Recurrence

  30 days

• pain score

  VAS score under 4,VAS score above 4

  24 hours

Secondary Outcomes (1)

• sinus volume measurement

  24 hours

Study Arms (4)

Crystallized Phenol Applied Group (Group P) n:21

ACTIVE COMPARATOR

the pilonidal sinus (PS) periphery was cleaned using an antiseptic solution. A clamp was used to widen the sinus opening. The sinuses were thoroughly cleansed. Hair and granulation tissue were removed by curettage. Nitrofurantoin pomade (FurocinR Eczacıbaşı Istanbul, Turkey) was applied around the sinus to protect it from burns. Sufficient crystallized phenol (BotaFarma Medical Ankara, Turkey) was applied to fill the cavity (approximately 3-5 gr). Because crystallized phenol liquefies as soon as it contacts the body, it was compressed with a sponge for two minutes to prevent disintegration. The sinus opening was closed with ointment. Patients were hospitalized for one day.

Procedure: Crystallized Phenol Applied

Endoscopy Group (Group EPSiT) n:22

ACTIVE COMPARATOR

The main sinus was enlarged to an initial width of 5 mm through which the pediatric cystoscope can pass. We utilized a 1% mannitol solution for sinus irrigation. The hair follicles and necrotic tissues were eliminated. Then, the sinus was effectively cauterized using a monopolar probe. The inside of the sinus was cleaned with a brush

Procedure: Crystallized Phenol Applied

Limberg Flap Group (Group L) n:23

ACTIVE COMPARATOR

The sinus tract was marked with an iodine solution given through the sinus opening. The rhomboid shape was drawn with a sterile pen, with all sides being equal. The edges of the flap were sketched. the sinus area was completely removed, extending down to the presacral fascia. If iodine solution or sinus was seen outside the incision line, the excision area was enlarged to avoid residuals. The flap was released. A 10-French drainage catheter was inserted. Patients were discharged from the hospital on the third day after surgery.

Procedure: Crystallized Phenol Applied

Modified Limberg Flap Group (Group ML) n:22

ACTIVE COMPARATOR

The sinus tract was marked with an iodine solution given through the sinus opening. The rhomboid shape was drawn with a sterile pen, with all sides being equal. The edges of the flap were sketched. the sinus area was completely removed, extending down to the presacral fascia. If iodine solution or sinus was seen outside the incision line, the excision area was enlarged to avoid residuals. The flap was released. A 10-French drainage catheter was inserted. Patients were discharged from the hospital on the third day after surgery.

Procedure: Crystallized Phenol Applied

Interventions

Crystallized Phenol Applied PROCEDURE

four different surgical methods for the treatment of sacrococcygeal pilonidal sinus

Also known as: Endoscopy Group, Limberg Flap Group, Modified Limberg Flap Group

Crystallized Phenol Applied Group (Group P) n:21; Endoscopy Group (Group EPSiT) n:22; Limberg Flap Group (Group L) n:23; Modified Limberg Flap Group (Group ML) n:22

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• having sacrococcygeal pilonidal sinus disease

You may not qualify if:

• Being over 18 years old or under 12 years old
• recurrent sacrococcygeal pilonidal sinus disease

Sponsors & Collaborators

• Zeliha Alicikus: lead

Study Sites (1)

Umraniye Education and Research Hospital

Istanbul, Umraniye, 34734, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Central Study Contacts

ZELİHA AKIŞ YILDIZ, md

CONTACT

+90 5305255542; zelihaakis@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. prof. dr

Model Details: randomized controlled

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 27, 2026
• Study Start: April 30, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)