Pediatric Pilonidal Sinus Surgical Treatment

Zeliha Alicikus

Status: Enrolling

Conditions: Surgery; Pilonidal Sinus; Pediatric

Treatments: Procedure: Crystallized Phenol Applied

Study type: Interventional

Funder types: Other

Identifiers

NCT07369921

Z.AKIŞ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups

Crystallized Phenol Applied Group (Group P) n:21

Active Comparator group

Description:

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.

Treatment:

Procedure: Crystallized Phenol Applied

Endoscopy Group (Group EPSiT) n:22

Active Comparator group

Description:

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

Treatment:

Procedure: Crystallized Phenol Applied

Limberg Flap Group (Group L) n:23

Active Comparator group

Description:

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.

Treatment:

Procedure: Crystallized Phenol Applied

Modified Limberg Flap Group (Group ML) n:22

Active Comparator group

Description:

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.

Treatment:

Procedure: Crystallized Phenol Applied