Clinical trial NCT01662765: Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease
Official title: Conservative Versus Surgical Treatment of Umbilical Pilonidal Sinus Disease: A Prospective, Randomised, and Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Sinus
Sinus; Dermal, Pilonidal
Umbilical Granuloma
Keywords: Umbilical pilonidal sinus
Treatment
Surgery
Conservative
Investigational treatment
After care
Lead sponsor: Medical Park Gaziantep Hospital
Sponsor class: OTHER
Collaborators: name: Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.
First posted: 2012-08-10
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cure Rate
timeFrame: 2 year after initial treatment
Secondary outcomes:
measure: Healing Time
timeFrame: two year
measure: Visual Analogue Scale for Patient Satisfaction (VAS-PS)
timeFrame: 30 days
Other outcomes:
measure: Costs
timeFrame: two year
Locations:
city: Gaziantep
country: Turkey
facility: Hatem Hospital
city: Gaziantep
country: Turkey
facility: Medical Park Gaziantep Hospital
city: Gaziantep
country: Turkey
facility: 25 Aralık Familiy Physician Health Center
city: Gaziantep
country: Turkey
facility: Dr.Ersin Arslan State Hospital
city: Gaziantep
country: Turkey
facility: Şehitkamil State Hospital
Study officials:
affiliation: Medical Park Gaziantep Hospital, Gaziantep, Turkey
name: Mehmet KAPLAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaplan M, Ozcan O, Kaplan FC, Yalcin HC, Salman B. Conservative vs Surgical Interventions for Umbilical Pilonidal Sinus: A Multicenter, Double-Blind, Prospective, Randomized Clinical Trial. J Am Coll Surg. 2016 May;222(5):878-89. doi: 10.1016/j.jamcollsurg.2016.01.056. Epub 2016 Feb 23.