NCT03007173

Brief Summary

Umbilical pilonidal sinus (UPS) is a rare disease of young, hirsute, dark men with deep navels and poor personal hygiene; however, it can be seen in females. UPS could easily be misdiagnosed and mistreated due to its rarity and lack of awareness in physicians. Diagnosis is easy to establish with physical examination and a detailed history. Treatment is generally depending on the severity of the disease, ranging from good personal hygiene to surgical excision of umbilical complex. The treatment of choice for chronic, intermittent cases is surgical removal of the affected portion; paying special attention to cosmetic appearance especially in female patients. In this report, we present two cases of UPS, one in a man and one in a woman with the explanation of its etiopathogenesis and surgical treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

December 22, 2016

Last Update Submit

December 28, 2016

Conditions

Keywords

umbilical pilonidal sinus

Outcome Measures

Primary Outcomes (1)

  • cure rate

    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.

    within 2 years of follow-up

Secondary Outcomes (1)

  • healing time

    within the postoperative 1 month

Interventions

excision of umbilical complex

Also known as: pilonidal sinus excision

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

No limitation for age, gender, ethnicity

You may qualify if:

  • no limitation

You may not qualify if:

  • patients followed-up less than 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehmet Kaplan

Gaziantep, Gaziantep, 27090, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 27016906BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

soft tissue composed of umbilical cyst

MeSH Terms

Conditions

Urachal CystPilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

  • Mehmet Kaplan, M.D.

    Medical Park Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2016

First Posted

January 2, 2017

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2016

Last Updated

January 2, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations