Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease

• ClinicalTrials.gov Identifier: NCT01662765
• Recruitment Status: Completed
• First Posted: August 10, 2012
• Results First Posted: February 16, 2017
• Last Update Posted: February 16, 2017
• Sponsor: Medical Park Gaziantep Hospital
• Collaborator: Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.
• Information provided by (Responsible Party): Mehmet Kaplan, Medical Park Gaziantep Hospital

Tracking Information

• First Submitted Date: August 8, 2012
• First Posted Date: August 10, 2012
• Results First Submitted Date: January 18, 2016
• Results First Posted Date: February 16, 2017
• Last Update Posted Date: February 16, 2017
• Study Start Date: November 2003
• Actual Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 23, 2016)

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.

Original Primary Outcome Measures (submitted: August 9, 2012)

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. 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.

• Change History: Complete list of historical versions of study NCT01662765 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: December 23, 2016)

• 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).

Original Secondary Outcome Measures (submitted: August 9, 2012)

• 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.
• complications [ Time Frame: two years ]
  formation chronic non-healing wound, bleeding, and infection
• patient satisfaction [ Time Frame: two years ]
  it will evaluated in five categories as follow: very satisfied, satisfied, not bad, unsatisfied, worst

Current Other Pre-specified Outcome Measures (submitted: August 9, 2012)

Costs [ Time Frame: two year ]

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Pilonidal Sinus
• Sinus; Dermal, Pilonidal
• Umbilical Granuloma

Intervention

• Procedure: Surgery
  modified umbilectomy
  Other Name: umbilectomy
• Other: conservative
  this treatment will include conservative procedures under local anesthesia for patient comfort.
  Other Name: non-surgical management

Study Arms

• 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.

  Intervention: Procedure: Surgery
• 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.

  Intervention: Other: conservative

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 9, 2012): 84
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2012
• Actual Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT01662765
• Other Study ID Numbers: MK-003-UPS
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Mehmet Kaplan, Medical Park Gaziantep Hospital
• 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

• PRS Account: Medical Park Gaziantep Hospital
• Verification Date: December 2016