Endoscopic Pilonidal SinusNCT04418310
Intervetional Lay Open and Curettage Versus Endoscopic (E.P.Si.T) Method in the Treatment of Sacrococcygeal Pilonidal Sinus Disease
A study testing Lay open and curettage and Endoscopic (E.P.Si.T) method in people with Endoscopic Pilonidal Sinus, run by Mansoura University at 1 site in Egypt.
Trial summary
Aim of the work To compare lay open technique versus Endoscopic pilonidal sinus treatment as regards recurrence rate, operative data, postoperative pain, intra and postoperative complications, healing time and return to daily activity Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endoscopic Pilonidal Sinus
- What is being tested?
- Lay open and curettage and Endoscopic (E.P.Si.T) method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jun 2020to Jul 2021
- Phase
- Interventional
- 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
Who may be able to join
- Adult patients of both genders with symptoms from sacrococcygeal pilonidal sinus were included in our study.
Who cannot join
- Abscess formation 2. Immunodeficiency. 3. Patients with congenital asymptomatic pits. 4. Patient with psychiatric disease disabling surgical intervention. 5. Pregnant females
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University
Al Mansurah, Dakahlia Governorate
Mohamed Hamada Mohamed Hamada, +20 109 212 7930, irb.mfm@hotmail.com
About this study
Official title: Lay Open and Curettage Versus Endoscopic (E.P.Si.T) Method in the Treatment of Sacrococcygeal Pilonidal Sinus Disease
Aim of the work To compare lay open technique versus Endoscopic pilonidal sinus treatment as regards recurrence rate, operative data, postoperative pain, intra and postoperative complications, healing time and return to daily activity
Read the detailed description
Introduction Pilonidal sinus is a very common inflammatory disease of gluteal region (McCallum et al., 2008). Its incidence is 26/100,000 and it usually occurs in working males of age 15 to 30.
The disease itself dates back to 1833 when Herbert Mayo, British Physiologist, Anatomist and Surgeon described it as a sinus containing hair follicles located in the sacrococcygeal region in a woman.
- Conditions
- Endoscopic Pilonidal Sinus
- Being tested
- Lay open and curettage, Endoscopic (E.P.Si.T) method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lay open and curettageProcedure or surgery
Lay open and curettage
Endoscopic (E.P.Si.T) methodProcedure or surgery
Endoscopic (E.P.Si.T) method
| Study group | Role | What they receive |
|---|---|---|
| Lay open and curettage | Active comparator | Lay open and curettage in Pilonidal sinus Receives: Procedure: Lay open and curettage |
| Endoscopic (E.P.Si.T) method | Active comparator | Endoscopic (E.P.Si.T) method in the treatment of sacrococcygeal pilonidal sinus disease Receives: Procedure: Endoscopic (E.P.Si.T) method |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate
recurrence rate of pilonidal sinus symptoms after healing
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start12 Jun 2020
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418310
- Sponsor's protocol ID
- Epsit Pilonidal sinus
- Status last verified
- May 2020
- First submitted
- 3 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lay Open and Curettage Versus Endoscopic (E.P.Si.T) Method in the Treatment of Sacrococcygeal Pilonidal Sinus Disease
- ClinicalTrials.gov ID
- NCT04418310
- Acronym / sponsor ID
- Epsit Pilonidal sinus
- Conditions
- Endoscopic Pilonidal Sinus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 5 Jun 2020 (actual)
- 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.
Aim of the work To compare lay open technique versus Endoscopic pilonidal sinus treatment as regards recurrence rate, operative data, postoperative pain, intra and postoperative complications, healing time and return to daily activity
Detailed description
Introduction Pilonidal sinus is a very common inflammatory disease of gluteal region (McCallum et al., 2008). Its incidence is 26/100,000 and it usually occurs in working males of age 15 to 30.
The disease itself dates back to 1833 when Herbert Mayo, British Physiologist, Anatomist and Surgeon described it as a sinus containing hair follicles located in the sacrococcygeal region in a woman.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lay open and curettage | Active comparator | Procedure: Lay open and curettageLay open and curettage in Pilonidal sinus |
| Endoscopic (E.P.Si.T) method | Active comparator | Procedure: Endoscopic (E.P.Si.T) methodEndoscopic (E.P.Si.T) method in the treatment of sacrococcygeal pilonidal sinus disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients of both genders with symptoms from sacrococcygeal pilonidal sinus were included in our study.
Key exclusion criteria (1 listed)
- Abscess formation 2. Immunodeficiency. 3. Patients with congenital asymptomatic pits. 4. Patient with psychiatric disease disabling surgical intervention. 5. Pregnant females
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 |
|---|---|---|
| Lay open and curettageLay open and curettage | Procedure or surgery | Lay open and curettage |
| Endoscopic (E.P.Si.T) methodEndoscopic (E.P.Si.T) method | Procedure or surgery | Endoscopic (E.P.Si.T) method |
Primary outcome
recurrence rate
Time frame: one year
recurrence rate of pilonidal sinus symptoms after healing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lay open and curettage and Endoscopic (E.P.Si.T) method in people with Endoscopic Pilonidal Sinus, run by Mansoura University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 18 Jun 2020. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Arnouse (01099222561, drmhamdy@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate (time frame: one year). 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 18 Jun 2020.