Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease

December 23, 2016 updated by: Mehmet Kaplan, Medical Park Gaziantep Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Gaziantep, Turkey, 27090
        • Hatem Hospital
      • Gaziantep, Turkey, 27090
        • Medical Park Gaziantep Hospital
      • Gaziantep, Turkey, 27100
        • 25 Aralık Familiy Physician Health Center
      • Gaziantep, Turkey, 27100
        • Dr.Ersin Arslan State Hospital
      • Gaziantep, Turkey, 27100
        • Şehitkamil State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Surgery

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
modified umbilectomy
Other Names:
  • umbilectomy
ACTIVE_COMPARATOR: Conservative

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
this treatment will include conservative procedures under local anesthesia for patient comfort.
Other Names:
  • non-surgical management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 year after initial treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
two year
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).
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Costs
Time Frame: two year
from initial treatment to the complete healing, all kind of cost will be calculated.
two year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Park Gaziantep Hospital

Collaborators

Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.

Investigators

  • Principal Investigator: Mehmet KAPLAN, MD, Medical Park Gaziantep Hospital, Gaziantep, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

August 8, 2012

First Submitted That Met QC Criteria

August 9, 2012

First Posted (ESTIMATE)

August 10, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2017

Last Update Submitted That Met QC Criteria

December 23, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MK-003-UPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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