Evaluate and Compare Between Excision and Primary Closure Procedure and Rhomboid Flap Technique for the Treatment of Pilonidal SinusnonNCT01223599
Rhomboid Flap Versus Primary Closure After Excision of Sacrococcygeal Pilonidal Sinus. (A Prospective Randomized Study)
An observational study of Evaluate and Compare Between Excision and Primary Closure Procedure and Rhomboid Flap Technique for the Treatment of Pilonidal Sinus and Duration of Operation,, run by Mansoura University.
Trial summary
To evaluate and compare between excision with primary closure of wound and excision with Rhomboid flap reconstruction in the treatment of pilonidal sinus as regard duration of operation, healing time, hospital stay, complications and recurrence rate. Read more about this study
- Who is it for?
- Ages 15 to 43 years
- Conditions the study is for
- Evaluate and Compare Between Excision and Primary Closure Procedure and Rhomboid Flap Technique for the Treatment of Pilonidal Sinus, Duration of Operation,
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Mar 2010
- 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 15 to 43 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: both sex different age april 2008-march 2010
Who may be able to join
- chronic pilonidal sinus
Who cannot join
- pilonidal abcess
About this study
Official title: Rhomboid Flap Versus Primary Closure
To evaluate and compare between excision with primary closure of wound and excision with Rhomboid flap reconstruction in the treatment of pilonidal sinus as regard duration of operation, healing time, hospital stay, complications and recurrence rate.
- Conditions
- Evaluate and Compare Between Excision and Primary Closure Procedure and Rhomboid Flap Technique for the Treatment of Pilonidal Sinus, Duration of Operation,
- Keywords
- pilonidal disease, natal cleft, limberg flap
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startApr 2008
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate and Compare Between Excision and Primary Closure Procedure and Rhomboid Flap Technique for the Treatment of 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223599
- Sponsor's protocol ID
- non
- Acronym
- non
- Status last verified
- Oct 2010
- First submitted
- 18 Oct 2010
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhomboid Flap Versus Primary Closure
- ClinicalTrials.gov ID
- NCT01223599
- Acronym / sponsor ID
- non / non
- Conditions
- Evaluate and Compare Between Excision and Primary Closure Procedure and Rhomboid Flap Technique for the Treatment of Pilonidal Sinus, Duration of Operation,
- Keywords
- pilonidal disease, natal cleft, limberg flap
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Study completion
- Mar 2010
- First posted
- 19 Oct 2010 (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.
To evaluate and compare between excision with primary closure of wound and excision with Rhomboid flap reconstruction in the treatment of pilonidal sinus as regard duration of operation, healing time, hospital stay, complications and recurrence rate.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 43 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- both sex different age april 2008-march 2010
Key inclusion criteria (1 listed)
- chronic pilonidal sinus
Key exclusion criteria (1 listed)
- pilonidal abcess
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2010.
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?
An observational study of Evaluate and Compare Between Excision and Primary Closure Procedure and Rhomboid Flap Technique for the Treatment of Pilonidal Sinus and Duration of Operation,, 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 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: withdrawn, as of the sponsor's last update on 19 Oct 2010. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 19 Oct 2010.