RecurrencePhase 1videosinusNCT01583751
Videoendoscopic Pilonidal Sinus Surgery
A Phase 1 study testing videoendoscopic resection of pilonidal sinus in people with Recurrence and Postoperative Complication, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study examines performing pilonidal sinus surgery minimal invasively with videoendoscopic approach. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Recurrence, Postoperative Complication
- What is being tested?
- videoendoscopic resection of pilonidal sinus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2011to Mar 2013
- Phase
- Phase 1
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- symptomatic pilonidal sinus disease
- primer pilonidal sinus disease
- noncomplicated pilonidal sinus disease
Who cannot join
- Asymptomatic pilonidal sinus disease
- Recurrence pilonidal sinus disease
- complicated pilonidal sinus disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, 34545
adnan yuksel, Prof, +902124531700, ayuksel@bezmialem.edu.tr
erhan aysan, assoc. prof.
About this study
Official title: Videoendoscopic Pilonidal Sinus Surgery. A New Technique
This study examines performing pilonidal sinus surgery minimal invasively with videoendoscopic approach.
Read the detailed description
Lots of surgical techniques are performing on pilonidal sinus disease treatment. Lately large flap techniques are popular but causing anatomical distortions and bad cosmesis. In this new approach the investigators concluded that two 1cm diameter holes are enough to surgical treatment. One hole is for videoendoscopic camera and the other one for grasper to extract piluses and granulation tissues.
- Conditions
- Recurrence, Postoperative Complication
- Being tested
- videoendoscopic resection of pilonidal sinus
- Keywords
- pilonidal sinus, new technique, videoendoscopic
- Medical subject headings
- Recurrence, Postoperative Complications, Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videoendoscopic resection of pilonidal sinusProcedure or surgery
Also called Active Comparator: Control: Group 1, Procedure/Surgery: Videoendoscopic: Group-2
Resection of pilonidal sinus tissue with videoendoscopic approach.
| Study group | Role | What they receive |
|---|---|---|
| control | Experimental | excision and primer repair surgical technique will be perform Receives: Procedure: videoendoscopic resection of pilonidal sinus |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rates
primary outcome measure of effectivity of pilonidal sinus surgery is recurrence rates.
Measured: six months
Secondary outcomes (1)
postoperative complications, wound healing
Postoperative complications such as bleeding and infection are important outcome measurements. Wound healing time is the other important one.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startMar 2011
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecurrenceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SB Istanbul Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erhan Aysan, SB Istanbul Education and Research Hospital
- Investigators
- erhan aysan, assoc prof, Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583751
- Sponsor's protocol ID
- pilonidal1
- Acronym
- videosinus
- Status last verified
- Apr 2012
- First submitted
- 21 Jul 2011
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videoendoscopic Pilonidal Sinus Surgery. A New Technique
- ClinicalTrials.gov ID
- NCT01583751
- Acronym / sponsor ID
- videosinus / pilonidal1
- Conditions
- Recurrence, Postoperative Complication
- Keywords
- pilonidal sinus, new technique, videoendoscopic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SB Istanbul Education and Research HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 24 Apr 2012 (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.
This study examines performing pilonidal sinus surgery minimal invasively with videoendoscopic approach.
Detailed description
Lots of surgical techniques are performing on pilonidal sinus disease treatment. Lately large flap techniques are popular but causing anatomical distortions and bad cosmesis. In this new approach the investigators concluded that two 1cm diameter holes are enough to surgical treatment. One hole is for videoendoscopic camera and the other one for grasper to extract piluses and granulation tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control | Experimental | Procedure: videoendoscopic resection of pilonidal sinusexcision and primer repair surgical technique will be perform |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- symptomatic pilonidal sinus disease
- primer pilonidal sinus disease
- noncomplicated pilonidal sinus disease
Key exclusion criteria (3 listed)
- Asymptomatic pilonidal sinus disease
- Recurrence pilonidal sinus disease
- complicated pilonidal sinus disease
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 |
|---|---|---|
| videoendoscopic resection of pilonidal sinusAlso: Active Comparator: Control: Group 1, Procedure/Surgery: Videoendoscopic: Group-2Resection of pilonidal sinus tissue with videoendoscopic approach. | Procedure or surgery | control |
Primary outcome
recurrence rates
Time frame: six months
primary outcome measure of effectivity of pilonidal sinus surgery is recurrence rates.
1 secondary outcome
postoperative complications, wound healing
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
Related trials for Recurrence
RecruitingObservational study
Master Framework For Relapse or Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
RecruitingPhase 3
IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.
Acute Myeloid Leukemia, Relapse/Recurrence
RecruitingPhase 3
FH-006 Versus Investigator's Choice of Chemotherapy in Patients With Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma Who Have Failed Prior PD-1/PD-L1 Inhibitor Combined With Platinum-Based Chemotherapy.
Locally Advanced, Recurrent or Metastatic ESCC Patients Who Have Failed Prior PD-1/PD-L1 Inhibitors Combined With Platinum-based Chemotherapy
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
Not yet recruitingPhase 1
CLL-1/CD70 Dual-Target CAR-T Cell Therapy for Acute Myeloid Leukemia
Acute Myeloid Leukemia (AML), Relapsed/Refractory Acute Myeloid Leukemia
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.
erhan aysan, assoc prof study director
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing videoendoscopic resection of pilonidal sinus in people with Recurrence and Postoperative Complication, run by SB Istanbul Education and Research 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Apr 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact erhan aysan, assoc prof (+904531700, dr@webcerrah.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rates (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2012; AzTrials last refreshed its copy on 28 Oct 2026.