Umbilical CystNCT03007173
Umbilical Pilonidal Sinus: a Case Report
An observational study of Umbilical Cyst and Pilonidal Sinus, run by Medical Park Gaziantep Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Umbilical Cyst, Pilonidal Sinus
- What is being tested?
- umbilicus preserving surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: No limitation for age, gender, ethnicity
Who may be able to join
- no limitation
Who cannot join
- patients followed-up less than 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Umbilical Pilonidal Sinus: an Underestimated and Little-known Clinical Entity - Report of Two Cases
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.
Read the detailed description
Introduction: Umbilical pilonidal sinus (UPS) is a rare disease of young, hirsute, dark men with deep navels and poor personal hygiene. It is being diagnosed and reported more frequently; however, there is still no consensus regarding its best treatment options.
Presentation of cases: In this report, we present two cases of UPS, one in a man and one in a woman who had typical symptoms with pain, swelling and intermittent malodorous discharge from the umbilicus. They had small sinus openings with hair protruding deep in the navel. Because patients had previous history of failed conservative treatments an umbilicus preserving surgery was performed for both cases.
- Conditions
- Umbilical Cyst, Pilonidal Sinus
- Being tested
- umbilicus preserving surgery
- Keywords
- umbilical pilonidal sinus
- Medical subject headings
- Urachal Cyst, Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilicus preserving surgeryProcedure or surgery
Also called pilonidal sinus excision
excision of umbilical complex
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 2 years of follow-up
Secondary outcomes (1)
healing time
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.
Measured: within the postoperative 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Umbilical CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Park Gaziantep Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Kaplan, Medical Park Gaziantep Hospital
- Investigators
- Mehmet Kaplan, M.D., Principal investigator, Medical Park Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007173
- Sponsor's protocol ID
- MK-013-UPS
- Status last verified
- Dec 2016
- First submitted
- 22 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 27016906
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Pilonidal Sinus: an Underestimated and Little-known Clinical Entity - Report of Two Cases
- ClinicalTrials.gov ID
- NCT03007173
- Acronym / sponsor ID
- MK-013-UPS
- Conditions
- Umbilical Cyst, Pilonidal Sinus
- Keywords
- umbilical pilonidal sinus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Medical Park Gaziantep HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: Umbilical pilonidal sinus (UPS) is a rare disease of young, hirsute, dark men with deep navels and poor personal hygiene. It is being diagnosed and reported more frequently; however, there is still no consensus regarding its best treatment options.
Presentation of cases: In this report, we present two cases of UPS, one in a man and one in a woman who had typical symptoms with pain, swelling and intermittent malodorous discharge from the umbilicus. They had small sinus openings with hair protruding deep in the navel. Because patients had previous history of failed conservative treatments an umbilicus preserving surgery was performed for both cases.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- No limitation for age, gender, ethnicity
Key inclusion criteria (1 listed)
- no limitation
Key exclusion criteria (1 listed)
- patients followed-up less than 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| umbilicus preserving surgeryAlso: pilonidal sinus excisionexcision of umbilical complex | Procedure or surgery | – |
Primary outcome
cure rate
Time frame: within 2 years of follow-up
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.
1 secondary outcome
healing time
Time frame: within the postoperative 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Background: PubMed 27016906Kaplan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Kaplan, M.D. principal investigator
Medical Park Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Umbilical Cyst and Pilonidal Sinus, run by Medical Park Gaziantep Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cure rate (time frame: within 2 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03007173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2017.