Pilonidal SinusNCT05892198
A Single Center Experience in the Management of Pilonidal Disease
A study testing surgery in people with Pilonidal Sinus, run by Mansoura University.
Trial summary
Sacrococcygeal pilonidal disease (PND) is a common entity affecting the skin and subcutaneous tissue of the upper portion of the natal cleft of the buttocks. It is characterized by the presence of sinus tracts with recurrent inflammation and infection. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Dec 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both sexes
- aging between 18- 60 years old
- who underwent surgical intervention for the pilonidal sinus (Either primary or recurrent)
- The surgical intervention includes excision with primary closure or lay open technique, Rhomboid flap and rotational flap.
Who cannot join
- surgically unfit due to commodities.
- those who lost follow up
About this study
Official title: A Single Center Experience in the Management of Pilonidal Disease; the Impact of Pits Location on the Choice of the Best Surgical Option.
Sacrococcygeal pilonidal disease (PND) is a common entity affecting the skin and subcutaneous tissue of the upper portion of the natal cleft of the buttocks. It is characterized by the presence of sinus tracts with recurrent inflammation and infection. It poses a significant healthcare problem due to its related morbidity, impaired quality of life, and financial costs.
Read the detailed description
This acquired disease is caused by negative suction of the hair present in the natal cleft region, leading to a foreign body reaction and subsequent granuloma . It affects 26 per 100000 people, and it mainly affects young men . Surgery for PND is frequently performed in Egypt by general surgeons, with no published data regarding its incidence or prevalence in the Egyptian population.
The PND patient may report different presentations ranging from asymptomatic disease to acute infection and abscess formation. Others may have a chronic disease with recurrent perianal inflammation and discharge.
Multiple surgical options have been described for chronic PND. However, no technique has been universally accepted. The idea of any procedure is to excise the pits with the related sinus tracts leaving healthy tissue as possible to decrease recurrence. The most commonly performed surgical techniques include excision with either primary closure, lay open, or flap-based reconstruction.
- Conditions
- Pilonidal Sinus
- Being tested
- surgery
- Keywords
- sacrococcygeal pilonidal sinus, primary closure, limberg flap, rotational flap
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
Also called surgical procedure
surgery with primary closure, Rhomboid flap , or Rotational flap
| Study group | Role | What they receive |
|---|---|---|
| primary closure | Active comparator | The group in which the pits location were in midline ,underwent excision with primary closure Receives: Procedure: surgery |
| Rhomboid flap group | Active comparator | in which more lateral pits and pits located <2cm from mid line natal cleft Receives: Procedure: surgery |
| Rotational flap group | Active comparator | in which more lateral pits and pits located >2cm from mid line natal cleft Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Select the best operative technique as regard the number and distribution of the pits in pilonidal sinus cases.
best surgical option based on pits location
Measured: 6 months
Recurrence rate
how many cases developed recurrence
Measured: 6 months - 1 year
Secondary outcomes (1)
the incidence of complications such as: wound infection, wound dehiscence, postoperative pain.
complication rate
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 posted7 Jun 2023
- Study start1 Jan 2015
- Primary completion30 Jun 2020
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal SinusStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Sakr, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892198
- Sponsor's protocol ID
- 1122
- Status last verified
- May 2023
- First submitted
- 28 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Experience in the Management of Pilonidal Disease; the Impact of Pits Location on the Choice of the Best Surgical Option.
- ClinicalTrials.gov ID
- NCT05892198
- Acronym / sponsor ID
- 1122
- Conditions
- Pilonidal Sinus
- Keywords
- sacrococcygeal pilonidal sinus, primary closure, limberg flap, rotational flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 7 Jun 2023 (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.
Sacrococcygeal pilonidal disease (PND) is a common entity affecting the skin and subcutaneous tissue of the upper portion of the natal cleft of the buttocks. It is characterized by the presence of sinus tracts with recurrent inflammation and infection. It poses a significant healthcare problem due to its related morbidity, impaired quality of life, and financial costs.
Detailed description
This acquired disease is caused by negative suction of the hair present in the natal cleft region, leading to a foreign body reaction and subsequent granuloma . It affects 26 per 100000 people, and it mainly affects young men . Surgery for PND is frequently performed in Egypt by general surgeons, with no published data regarding its incidence or prevalence in the Egyptian population.
The PND patient may report different presentations ranging from asymptomatic disease to acute infection and abscess formation. Others may have a chronic disease with recurrent perianal inflammation and discharge.
Multiple surgical options have been described for chronic PND. However, no technique has been universally accepted. The idea of any procedure is to excise the pits with the related sinus tracts leaving healthy tissue as possible to decrease recurrence. The most commonly performed surgical techniques include excision with either primary closure, lay open, or flap-based reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| primary closure | Active comparator | Procedure: surgeryThe group in which the pits location were in midline ,underwent excision with primary closure |
| Rhomboid flap group | Active comparator | Procedure: surgeryin which more lateral pits and pits located <2cm from mid line natal cleft |
| Rotational flap group | Active comparator | Procedure: surgeryin which more lateral pits and pits located >2cm from mid line natal cleft |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both sexes
- aging between 18- 60 years old
- who underwent surgical intervention for the pilonidal sinus (Either primary or recurrent)
- The surgical intervention includes excision with primary closure or lay open technique, Rhomboid flap and rotational flap.
Key exclusion criteria (2 listed)
- surgically unfit due to commodities.
- those who lost follow up
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: surgical proceduresurgery with primary closure, Rhomboid flap , or Rotational flap | Procedure or surgery | Rhomboid flap group, Rotational flap group, primary closure |
Primary outcome
Select the best operative technique as regard the number and distribution of the pits in pilonidal sinus cases.
Time frame: 6 months
best surgical option based on pits location
Recurrence rate
Time frame: 6 months - 1 year
how many cases developed recurrence
1 secondary outcome
the incidence of complications such as: wound infection, wound dehiscence, postoperative pain.
Time frame: 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 7 Jun 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing surgery in people with Pilonidal Sinus, run by Mansoura University.
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 4 inclusion and 2 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 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Select the best operative technique as regard the number and distribution of the pits in pilonidal sinus cases. (time frame: 6 months). The study lists 2 primary outcomes in all. 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 7 Jun 2023.