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Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease

This study has been completed.
Sponsor:
Collaborator:
Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.
Information provided by (Responsible Party):
Mehmet Kaplan, Medical Park Gaziantep Hospital
ClinicalTrials.gov Identifier:
NCT01662765
First received: August 8, 2012
Last updated: December 23, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention
Pilonidal Sinus Sinus; Dermal, Pilonidal Umbilical Granuloma Procedure: Surgery Other: conservative

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Conservative Versus Surgical Treatment of Umbilical Pilonidal Sinus Disease: A Prospective, Randomised, and Multicenter Clinical Trial

Further study details as provided by Mehmet Kaplan, Medical Park Gaziantep Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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 Outcome Measures:
  • Costs [ Time Frame: two year ]
    from initial treatment to the complete healing, all kind of cost will be calculated.


Enrollment: 84
Study Start Date: November 2003
Study Completion Date: May 2012
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: non-surgical management

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

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01662765

Locations
Turkey
Hatem Hospital
Gaziantep, Turkey, 27090
Medical Park Gaziantep Hospital
Gaziantep, Turkey, 27090
25 Aralık Familiy Physician Health Center
Gaziantep, Turkey, 27100
Dr.Ersin Arslan State Hospital
Gaziantep, Turkey, 27100
Şehitkamil State Hospital
Gaziantep, Turkey, 27100
Sponsors and Collaborators
Medical Park Gaziantep Hospital
Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.
Investigators
Principal Investigator: Mehmet KAPLAN, MD Medical Park Gaziantep Hospital, Gaziantep, Turkey
  More Information

Additional Information:
Responsible Party: Mehmet Kaplan, Principal investigator, Medical Park Gaziantep Hospital
ClinicalTrials.gov Identifier: NCT01662765     History of Changes
Other Study ID Numbers: MK-003-UPS
Study First Received: August 8, 2012
Results First Received: January 18, 2016
Last Updated: December 23, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mehmet Kaplan, Medical Park Gaziantep Hospital:
Umbilical pilonidal sinus
Treatment
Surgery
Conservative
Investigational treatment
After care

Additional relevant MeSH terms:
Granuloma
Pilonidal Sinus
Lymphoproliferative Disorders
Lymphatic Diseases
Pathologic Processes
Cysts
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2017