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Completed

NCT Number: NCT01662765

Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

25 Aralık Familiy Physician Health Center, Gaziantep, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery

Procedure

modified umbilectomy

Other names: umbilectomy

Conservative

Other

this treatment will include conservative procedures under local anesthesia for patient comfort.

Other names: non-surgical management

Primary outcomes

  1. Cure Rate

    Time frame: 2 year after initial treatment

    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.

Secondary outcomes

  1. Healing Time

    Time frame: two year

    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.

  2. Visual Analogue Scale for Patient Satisfaction (VAS-PS)

    Time frame: 30 days

    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).

Other outcomes

  1. Costs

    Time frame: two year

    from initial treatment to the complete healing, all kind of cost will be calculated.

Sponsors and collaborators

Lead sponsor

Medical Park Gaziantep Hospital

Other

Collaborators

  • Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2010
Study completion
2012
First posted
Aug 10, 2012
Registry last updated
Feb 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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