Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease

Study Overview
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Brief Summary
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The aim of the study was to compare the results of conservative and surgical treatment, to create an algorithm for the management of the disease, and gain more information about the etiology, pathogenesis, and course of the disease. The investigators hypothesise that surgical treatment of UPS will be better than conservative management in terms of recurrence rate, healing time, patient comfort and satisfaction, and cost effectiveness.

Detailed Description
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Because of its rarity, umbilical pilonidal sinus (UPS) is still poorly understood in terms of diagnosis, etiology, and the best treatment options. UPS is thought caused by hair penetrating the skin, leading to a foreign-body reaction and development of a sinus lined with granulation tissue. Most of the patients complain of pain, discharge or bleeding from the umbilicus when symptoms develop. It can be diagnosed with a careful examination, in which hairs can be seen deep in the umbilicus and usually protrude from a small sinus. Regarding the optimal treatment of the disease, a complete consensus has not yet been achieved. Some publications are recommended conservative treatment, while surgical treatment is recommended in others. A more meaningful comparison of the two modalities is that of a randomized controlled trial. We, therefore, present our data of prospective randomized controlled clinical trial comparing conservative versus surgical treatment of UPS. This was a multicenter, prospective balanced randomization, double blind, active-controlled, parallel-group, superiority study conducted in Turkey, under the direction of a principal investigator (MK). Eligible patients with UPS were randomized for either conservative treatment (CT) or surgical treatment (ST), and then the results of both groups were compared.

Official Title
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Conservative Versus Surgical Treatment of Umbilical Pilonidal Sinus Disease: A Prospective, Randomised, and Multicenter Clinical Trial

Conditions
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Pilonidal Sinus, Sinus; Dermal, Pilonidal, Umbilical Granuloma

Intervention / Treatment
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* Procedure: Surgery
* Other: conservative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients willing to participate to the study with the diagnosis of umbilical pilonidal sinus Exclusion Criteria: no informed consent serious coagulation abnormalities known allergy to local anesthetics pregnancy, or women who refused contraception at the time of treatment other concomitant umbilical pathologies such as umbilical hernia, granuloma, dermoid cyst the patients who diagnosed with urachal and omphalomesenteric anomalies through radiological investigation patients who underwent umbilical operation
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery<br>Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium. Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination. | Procedure: Surgery<br>* modified umbilectomy<br>* Other names: umbilectomy;|
| Active Comparator: Conservative<br>Conservative treatment described as follow: Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus. postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry. | Other: conservative<br>* this treatment will include conservative procedures under local anesthesia for patient comfort.<br>* Other names: non-surgical management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure Rate | Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure. Recurrence was defined as the appearance of a new, active discharging sinus or granulation tissue with/without a bit of hairs in the deep of the umbilicus within two years after therapy. | 2 year after initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing Time | the time form initial treatment to healing the wound and/or sinus and/or granulation tissue and no any sign of drainage with no longer need for dressing and wound care in either treatment arms. | two year | 
| Visual Analogue Scale for Patient Satisfaction (VAS-PS) | Well-being and satisfaction scales comprised linear metric scales known as visual analogue scales, with grades from 0 (worst imaginable health state and extremely dissatisfied with the treatment) to 100 (best imaginable health state and extremely satisfied with the treatment). | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Umbilical pilonidal sinus, Treatment, Surgery, Conservative, Investigational treatment, After care