Pediatric Pilonidal Sinus Surgical Treatment

Comparison of Four Different Surgical Methods for the Treatment of Sacrococcygeal Pilonidal Sinus: a Randomized Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Pediatric; Pilonidal Sinus
• Intervention / Treatment: Procedure: Crystallized Phenol Applied

Detailed Description

Pilonidal sinus disease (PSD) is common in young adults and causes repeated infection and inflammation in the sacrococcygeal region. It is most common in men between the ages of 20 and 30, which is why most publications about PSD are part of adult series.

This study aims to determine which treatment option is more effective and beneficial for patients with sacrococcygeal pilonidal sinus. Furthermore, it aims to contribute to more positive treatment outcomes by identifying the causes of recurrence and morbidity in patients. Sacrococcygeal pilonidal sinus is quite common in adolescents. Treatment options vary from non-operative to endoscopic surgery. However, recurrence still occurs with every technique. Patients suffer from long treatment processes and morbidity. Although the exact causes of recurrence are not fully understood, it is thought that the patient's demographic characteristics and treatment option play a role. Most studies are retrospective and compare at most two treatment options. This is one of the reasons why it is not possible to reach a definitive conclusion about which treatment is more effective. Also, the number of studies conducted in the adolescent age group is limited. By conducting study prospectively and randomized, aim to prevent biased results.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ZELİHA AKIŞ YILDIZ, MD; Phone Number: +90 5305255542; Email: zelihaakis@gmail.com

Study Locations

• Turkey (Türkiye)
  • Umraniye
    • Istanbul, Umraniye, Turkey (Türkiye), 34734
      • Recruiting
      • Umraniye Education and Research Hospital
      • Contact: ZELİHA AKIŞ YILDIZ, MD; Phone Number: +90 5305255542; Email: zelihaakis@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• having sacrococcygeal pilonidal sinus disease
• written informed (family) consent were eligible for inclusion in this trial

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Crystallized Phenol Applied Group (Group P) n:21; 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; four different surgical methods for the treatment of sacrococcygeal pilonidal sinus; Other Names: Endoscopy Group; Limberg Flap Group; Modified Limberg Flap Group
Active Comparator: Endoscopy Group (Group EPSiT) n:22; 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; four different surgical methods for the treatment of sacrococcygeal pilonidal sinus; Other Names: Endoscopy Group; Limberg Flap Group; Modified Limberg Flap Group
Active Comparator: Limberg Flap Group (Group L) n:23; 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; four different surgical methods for the treatment of sacrococcygeal pilonidal sinus; Other Names: Endoscopy Group; Limberg Flap Group; Modified Limberg Flap Group
Active Comparator: Modified Limberg Flap Group (Group ML) n:22; 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; four different surgical methods for the treatment of sacrococcygeal pilonidal sinus; Other Names: Endoscopy Group; Limberg Flap Group; Modified Limberg Flap Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications	Recurrence	30 days
pain score	VAS score under 4,VAS score above 4	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sinus volume measurement	USG guided	24 hours

Collaborators and Investigators

• Sponsor: Zeliha Alicikus

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: January 18, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pediatric surgery; Pilonidal Sinus
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• Other Study ID Numbers: Z.AKIŞ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No