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: August 9, 2012
Last verified: August 2012
  Purpose

The Investigator's information in the Responsible Party data elements is not properly formatted. Please provide the investigator's "Official Title" (e.g., Director, Head of Otolaryngology, Principal Investigator, Clinical Professor).Pilonidal sinus disease is a common health problem. It is seen most frequently in the sacrococcygeal region. However, it can also observed in the umbilicus. Although rare, umbilical pilonidal sinus (UPS) disease, is still poorly understood both in terms of diagnosis or pathophysiology and the best treatment options. The incidence and the prevelance of the disease is thought to be 0.6% and %0.1, respectively, and is more common in males.

Pilonidal sinus disease of the umbilicus is caused by hair penetrating the skin, causing 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.

The first article, which can be considered as umbilical pilonidal sinus disease was first published by Dr. Warren in 1854, and he described the removal of a sprinkle of hair from the umbilicus. But the term "umbilical pilonidal sinus" was first described and used by Williams and Patey in 1956. Since this initial reference to umbilical pilonidal sinus there have been approximately only 30 reports in the literature. Most of them are case reports and remaining consists of small case series. But until now no prospective randomised studies have been published related to UPS.

UPS is one of the most neclected disease that few reported studies and lack of the prospective randomised studies in the literature, and no cosensus about the treatment of the disease supports this idea. However, it may be actually more common than thought and may be found more frequently if sought specifically.

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 etiologiy, 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 (Subject, 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 Medical Park Gaziantep Hospital:

Primary Outcome Measures:
  • cure rate [ Time Frame: 2 year after initial treatment ] [ Designated as safety issue: No ]
    Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure. In contrast, a 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 ] [ Designated as safety issue: No ]
    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.

  • complications [ Time Frame: two years ] [ Designated as safety issue: No ]
    formation chronic non-healing wound, bleeding, and infection

  • patient satisfaction [ Time Frame: two years ] [ Designated as safety issue: No ]
    it will evaluated in five categories as follow: very satisfied, satisfied, not bad, unsatisfied, worst


Other Outcome Measures:
  • costs [ Time Frame: two year ] [ Designated as safety issue: No ]
    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

Circulary incision 2-3 mm below the skin level in the umbilicus through the subcutaneos 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 containig pilonisal 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 subcutaneos 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

  Eligibility

Genders Eligible for Study:   Both
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
Medical Park Gaziantep Hospital
Gaziantep, Turkey, 27090
Dr.Ersin Arslan State Hospital
Gaziantep, Turkey, 27100
Şehitkamil State Hospital
Gaziantep, Turkey, 27100
Hatem Hospital
Gaziantep, Turkey, 27090
25 Aralık Familiy Physician Health Center
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:
No publications provided

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
Last Updated: August 9, 2012
Health Authority: Turkey: Ethics Committee

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

Additional relevant MeSH terms:
Pilonidal Sinus
Cysts
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014