Pilonidal SinusNCT01662765
Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease
A study testing Surgery and conservative in people with Pilonidal Sinus and Sinus; Dermal, Pilonidal, run by Medical Park Gaziantep Hospital at 5 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pilonidal Sinus, Sinus; Dermal, Pilonidal, Umbilical Granuloma
- What is being tested?
- Surgery and conservative
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 5 sitesTurkey (Türkiye)
- Study dates
- Nov 2003to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- all patients willing to participate to the study with the diagnosis of umbilical pilonidal sinus
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Turkey (Türkiye)5 sites
Hatem Hospital
Gaziantep, 27090
Medical Park Gaziantep Hospital
Gaziantep, 27090
25 Aralık Familiy Physician Health Center
Gaziantep, 27100
Dr.Ersin Arslan State Hospital
Gaziantep, 27100
Şehitkamil State Hospital
Gaziantep, 27100
About this study
Official title: Conservative Versus Surgical Treatment of Umbilical Pilonidal Sinus Disease: A Prospective, Randomised, and Multicenter Clinical Trial
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.
Read the 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.
- Being tested
- Surgery, conservative
- Keywords
- Umbilical pilonidal sinus, Treatment, Surgery, Conservative, Investigational treatment, After care
- Medical subject headings
- Pilonidal Sinus, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Also called umbilectomy
modified umbilectomy
conservativeOther
Also called non-surgical management
this treatment will include conservative procedures under local anesthesia for patient comfort.
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | 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. Receives: Procedure: Surgery |
| Conservative | Active comparator | 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. Receives: Other: conservative |
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: 2 year after initial treatment
Secondary outcomes (2)
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: two year
Visual Analogue Scale for Patient Satisfaction (VAS-PS)
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).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startNov 2003
- Primary completionMay 2010
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pilonidal SinusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Park Gaziantep Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.
- Responsible party
- Principal investigator, Mehmet Kaplan, Medical Park Gaziantep Hospital
- Investigators
- Mehmet KAPLAN, MD, Principal investigator, Medical Park Gaziantep Hospital, Gaziantep, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662765
- Sponsor's protocol ID
- MK-003-UPS
- Status last verified
- Dec 2016
- First submitted
- 8 Aug 2012
- Last updated
- 16 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Versus Surgical Treatment of Umbilical Pilonidal Sinus Disease: A Prospective, Randomised, and Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT01662765
- Acronym / sponsor ID
- MK-003-UPS
- Keywords
- Umbilical pilonidal sinus, Treatment, Surgery, Conservative, Investigational treatment, After care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Medical Park Gaziantep HospitalUniversity, hospital or other
- Collaborators
- Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.
- Study start
- Nov 2003
- Primary completion
- May 2010 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Posted 16 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: SurgeryCircular 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. |
| Conservative | Active comparator | Other: conservativeConservative 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients willing to participate to the study with the diagnosis of umbilical pilonidal sinus
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| SurgeryAlso: umbilectomymodified umbilectomy | Procedure or surgery | Surgery |
| conservativeAlso: non-surgical managementthis treatment will include conservative procedures under local anesthesia for patient comfort. | Other | Conservative |
Primary outcome
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.
2 secondary outcomes
Healing Time
Time frame: two year
Visual Analogue Scale for Patient Satisfaction (VAS-PS)
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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
Related trials for Pilonidal Sinus
Recruiting
VAAPS Combined With Loose Seton Drainage for Postoperative Self-Care: A Prospective Single-Arm Cohort Study
Pilonidal Sinus Disease
Not yet recruiting
Teach-Back Discharge Education After Pilonidal Sinus Surgery
Pilonidal Sinus Disease, Pilonidal Sinus Treatment
Recruiting
ENVELOP: Wound Care Following Pilonidal Sinus Surgery
Pilonidal Sinus, Wound Healing
Not yet recruiting
Laser Coagulation of Pilonidal Sinus With/Without Intraoperative Ultrasound Control
Pilonidal Cyst Without Abscess
Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction
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, MD principal investigator
Medical Park Gaziantep Hospital, Gaziantep, Turkey
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and conservative in people with Pilonidal Sinus and Sinus; Dermal, Pilonidal, run by Medical Park Gaziantep Hospital at 5 sites 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 7 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 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 16 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 2 year after initial treatment). 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 NCT01662765, 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 16 Feb 2017.