Pilonidal SinusNCT02712970
Staging System for Chronic Symptomatic Pilonidal Sinus Disease
An observational study of Pilonidal Sinus, run by Trabzon Numune Training and Research Hospital.
Trial summary
A staging system was defined based on morphological extent of disease (stage I to stage IV for primary disease, and stage R for recurrent disease). Specific surgical technique was used for each stage. Demographics, perioperative data, short-term and long-term outcomes were evaluated according to the disease stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- pit-picking technique, Bascom Cleft Lift and Rhomboid excision with the Limberg Flap
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 367 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jun 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that were operated because of chronic symptomatic pilonidal sinus disease
Who may be able to join
- Individuals with symptomatic pilonidal sinus disease.
Who cannot join
- <18 y
- Pilonidal sinus disease which identified incidentally and which presented with acute abscesses were not included to the staging system.
- Patients who were treated without the use of the suggested algorithm were excluded from the analysis.
About this study
Official title: A Proposed Staging System for Chronic Symptomatic Pilonidal Sinus Disease and Results in Patients Treated With Stage-based Approach
A staging system was defined based on morphological extent of disease (stage I to stage IV for primary disease, and stage R for recurrent disease). Specific surgical technique was used for each stage. Demographics, perioperative data, short-term and long-term outcomes were evaluated according to the disease stage.
Read the detailed description
The collected data of patients who underwent surgery for the treatment of pilonidal sinus disease prior to June 2011 were analyzed. Following this analysis, a staging system was defined based on morphological extent of disease (stage I to stage IV for primary disease, and stage R for recurrent disease). Specific surgical technique was used for each stage. "Pit-picking" technique was performed under local anesthesia on an outpatient basis in stage I and stage IIa patients. For stage IIb and stage III patients, the Bascom Cleft Lift /modified Bascom Cleft Lift techniques were performed. For stage IV patients, the rhomboid excision with the Limberg flap technique was used. Demographics, perioperative data, short-term and long-term outcomes were evaluated according to the disease stage.
- Conditions
- Pilonidal Sinus
- Being tested
- pit-picking technique, Bascom Cleft Lift, Rhomboid excision with the Limberg Flap, Other flap techniques
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pit-picking techniqueProcedure or surgery
midline pits were excised removing a minimal amount of tissue (with a margin of skin of <1 mm). Incision of 1-2 cm in length was performed parallel to the most convenient side of the midline to be curetted of the chronic abscess cavity. All infected granulation tissue and hair were removed. After establishing hemostasis, the area of the excised midline pits was approximated by absorbable sutures.
Bascom Cleft LiftProcedure or surgery
The upper end of the incision was made 1-2 cm lateral to the midline on the more affected side and this was continued vertically over a distance of 1-2 mm from the midline pits. The lower end was fashioned from the midline in a V-shape in order to prevent a dog-ear deformity. The skin on this side of the natal cleft was then elevated and excised. The skin on the opposite side was undermined to the distance required to allow primary closure of the defect away from the midline without tension. Sinus tissue and its extensions were excised. The incision was then closed subcuticularly by absorbable polyglecaprone (3-0), after which a few interrupted mattress polyglecaprone (3-0) buttress sutures were also inserted.
Rhomboid excision with the Limberg FlapProcedure or surgery
The area to be excised was mapped on the skin in a rhomboid form, and the flap was designed. The skin incision was deepened to the postsacral fascia. The flap was fully mobilized and transposed medially to fill the defect without tension. The wound was closed in two layers: the subcutaneous tissue with absorbable (2/0 polyglactin) sutures and the skin with nonabsorbable (3/0 polypropylene) interrupted mattress suture
Other flap techniquesProcedure or surgery
Bascom Cleft lift as described above, Rhomboid excision with the Limberg Flap as described above, V-Y advancement flap, Z-Plasty
| Study group | Role | What they receive |
|---|---|---|
| stage-I | Single pit in the midline, no lateral extension. Pit-picking technique will be performed. Receives: Procedure: pit-picking technique | |
| Stage-II | >1 pits in the midline, no lateral extension. Pit-picking and Bascom cleft lift techniques will be performed. Receives: Procedure: pit-picking technique; Procedure: Bascom Cleft Lift | |
| Stage-III | Midline pit/pits plus lateral extension in one direction. Bascom cleft lift technique will be performed. Receives: Procedure: Bascom Cleft Lift | |
| Stage-IV | Midline pit/pits plus lateral extension in both directions. Rhomboid excision with the Limberg Flap will be performed. Receives: Procedure: Rhomboid excision with the Limberg Flap | |
| Stage-R | Recurrent PSD following any type of treatment. Other flap techniques such as V-Y advancement flap, Z-Plasty will be performed. Receives: Procedure: Bascom Cleft Lift; Procedure: Rhomboid excision with the Limberg Flap; Procedure: Other flap techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early wound complications
Complications were classified as infection (superficial or deep), collection (seroma or hematoma), wound dehiscence (partial or complete), or anesthesia-related complications. complications will be reviewed from time of surgery to the end of healing. percentage of participants with any wound complication will be evaluated as patients with complication.
Measured: up to 3 months
Secondary outcomes (4)
Assessment of recurrence (recurrence is defined when symptoms of the disease recurred after an interval following complete wound healing.)
Patients will be followed up for recurrence for three years. Total number of patients presenting with recurrence will be evaluated at the end of 3rd year.
Measured: 3 years
Primary healing rate
All surgical site complications were recorded, and patients with prolonged healing were regularly examined until complete healing was achieved. Primary healing was defined as no breakdown of the wound (complication-free healing) at any point along its length.
Measured: within 3 months
Hospital stay "The interval from the day of surgery to the day of discharge was recorded as the ''hospital stay.''
hospital stay for patients in postoperative period will be measured from the day of surgery to the day of discharge (as days).
Measured: during first week (one week)
Operative duration (''Operative duration'' is defined as the time between the initiation of the incision and the application of the last suture.)
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startJan 2011
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trabzon Numune Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Karadeniz Technical University
- Responsible party
- Principal investigator, Ali GUNER, MD, Trabzon Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712970
- Sponsor's protocol ID
- TrabzonNTRH
- Status last verified
- Mar 2016
- First submitted
- 5 Mar 2016
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: because this is retrospective study.
Publications
Guner A, Boz A, Ozkan OF, Ileli O, Kece C, Reis E. Limberg flap versus Bascom cleft lift techniques for sacrococcygeal pilonidal sinus: prospective, randomized trial. World J Surg. 2013 Sep;37(9):2074-80. doi: 10.1007/s00268-013-2111-9.
PubMed 23732258Guner A, Ozkan OF, Kece C, Kesici S, Kucuktulu U. Modification of the Bascom cleft lift procedure for chronic pilonidal sinus: results in 141 patients. Colorectal Dis. 2013 Jul;15(7):e402-6. doi: 10.1111/codi.12243.
PubMed 23581906Bascom J, Bascom T. Utility of the cleft lift procedure in refractory pilonidal disease. Am J Surg. 2007 May;193(5):606-9; discussion 609. doi: 10.1016/j.amjsurg.2007.01.008.
PubMed 17434365Mentes O, Bagci M, Bilgin T, Ozgul O, Ozdemir M. Limberg flap procedure for pilonidal sinus disease: results of 353 patients. Langenbecks Arch Surg. 2008 Mar;393(2):185-9. doi: 10.1007/s00423-007-0227-9. Epub 2007 Sep 22.
PubMed 17899165Can MF, Sevinc MM, Hancerliogullari O, Yilmaz M, Yagci G. Multicenter prospective randomized trial comparing modified Limberg flap transposition and Karydakis flap reconstruction in patients with sacrococcygeal pilonidal disease. Am J Surg. 2010 Sep;200(3):318-27. doi: 10.1016/j.amjsurg.2009.08.042. Epub 2010 Feb 1.
PubMed 20122682Kement M, Oncel M, Kurt N, Kaptanoglu L. Sinus excision for the treatment of limited chronic pilonidal disease: results after a medium-term follow-up. Dis Colon Rectum. 2006 Nov;49(11):1758-62. doi: 10.1007/s10350-006-0676-1.
PubMed 16990977Guner A, Cekic AB, Boz A, Turkyilmaz S, Kucuktulu U. A proposed staging system for chronic symptomatic pilonidal sinus disease and results in patients treated with stage-based approach. BMC Surg. 2016 Apr 16;16:18. doi: 10.1186/s12893-016-0134-5.
PubMed 27084534
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proposed Staging System for Chronic Symptomatic Pilonidal Sinus Disease and Results in Patients Treated With Stage-based Approach
- ClinicalTrials.gov ID
- NCT02712970
- Acronym / sponsor ID
- TrabzonNTRH
- Conditions
- Pilonidal Sinus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Trabzon Numune Training and Research HospitalOther government
- Collaborators
- Karadeniz Technical University
- Study start
- Jan 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Mar 2016 (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.
A staging system was defined based on morphological extent of disease (stage I to stage IV for primary disease, and stage R for recurrent disease). Specific surgical technique was used for each stage. Demographics, perioperative data, short-term and long-term outcomes were evaluated according to the disease stage.
Detailed description
The collected data of patients who underwent surgery for the treatment of pilonidal sinus disease prior to June 2011 were analyzed. Following this analysis, a staging system was defined based on morphological extent of disease (stage I to stage IV for primary disease, and stage R for recurrent disease). Specific surgical technique was used for each stage. "Pit-picking" technique was performed under local anesthesia on an outpatient basis in stage I and stage IIa patients. For stage IIb and stage III patients, the Bascom Cleft Lift /modified Bascom Cleft Lift techniques were performed. For stage IV patients, the rhomboid excision with the Limberg flap technique was used. Demographics, perioperative data, short-term and long-term outcomes were evaluated according to the disease stage.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| stage-I | – | Procedure: pit-picking techniqueSingle pit in the midline, no lateral extension. Pit-picking technique will be performed. |
| Stage-II | – | Procedure: pit-picking technique, Procedure: Bascom Cleft Lift>1 pits in the midline, no lateral extension. Pit-picking and Bascom cleft lift techniques will be performed. |
| Stage-III | – | Procedure: Bascom Cleft LiftMidline pit/pits plus lateral extension in one direction. Bascom cleft lift technique will be performed. |
| Stage-IV | – | Procedure: Rhomboid excision with the Limberg FlapMidline pit/pits plus lateral extension in both directions. Rhomboid excision with the Limberg Flap will be performed. |
| Stage-R | – | Procedure: Bascom Cleft Lift, Procedure: Rhomboid excision with the Limberg Flap, Procedure: Other flap techniquesRecurrent PSD following any type of treatment. Other flap techniques such as V-Y advancement flap, Z-Plasty will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that were operated because of chronic symptomatic pilonidal sinus disease
Key inclusion criteria (1 listed)
- Individuals with symptomatic pilonidal sinus disease.
Key exclusion criteria (3 listed)
- <18 y
- Pilonidal sinus disease which identified incidentally and which presented with acute abscesses were not included to the staging system.
- Patients who were treated without the use of the suggested algorithm were excluded from the analysis.
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 |
|---|---|---|
| pit-picking techniquemidline pits were excised removing a minimal amount of tissue (with a margin of skin of <1 mm). Incision of 1-2 cm in length was performed parallel to the most convenient side of the midline to be curetted of the chronic abscess cavity. All infected granulation tissue and hair were removed. After establishing hemostasis, the area of the excised midline pits was approximated by absorbable sutures. | Procedure or surgery | Stage-II, stage-I |
| Bascom Cleft LiftThe upper end of the incision was made 1-2 cm lateral to the midline on the more affected side and this was continued vertically over a distance of 1-2 mm from the midline pits. The lower end was fashioned from the midline in a V-shape in order to prevent a dog-ear deformity. The skin on this side of the natal cleft was then elevated and excised. The skin on the opposite side was undermined to the distance required to allow primary closure of the defect away from the midline without tension. Sinus tissue and its extensions were excised. The incision was then closed subcuticularly by absorbable polyglecaprone (3-0), after which a few interrupted mattress polyglecaprone (3-0) buttress sutures were also inserted. | Procedure or surgery | Stage-II, Stage-III, Stage-R |
| Rhomboid excision with the Limberg FlapThe area to be excised was mapped on the skin in a rhomboid form, and the flap was designed. The skin incision was deepened to the postsacral fascia. The flap was fully mobilized and transposed medially to fill the defect without tension. The wound was closed in two layers: the subcutaneous tissue with absorbable (2/0 polyglactin) sutures and the skin with nonabsorbable (3/0 polypropylene) interrupted mattress suture | Procedure or surgery | Stage-IV, Stage-R |
| Other flap techniquesBascom Cleft lift as described above, Rhomboid excision with the Limberg Flap as described above, V-Y advancement flap, Z-Plasty | Procedure or surgery | Stage-R |
Primary outcome
Early wound complications
Time frame: up to 3 months
Complications were classified as infection (superficial or deep), collection (seroma or hematoma), wound dehiscence (partial or complete), or anesthesia-related complications. complications will be reviewed from time of surgery to the end of healing. percentage of participants with any wound complication will be evaluated as patients with complication.
4 secondary outcomes
Assessment of recurrence (recurrence is defined when symptoms of the disease recurred after an interval following complete wound healing.)
Time frame: 3 years
Primary healing rate
Time frame: within 3 months
Hospital stay "The interval from the day of surgery to the day of discharge was recorded as the ''hospital stay.''
Time frame: during first week (one week)
Operative duration (''Operative duration'' is defined as the time between the initiation of the incision and the application of the last suture.)
Time frame: during surgery
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 18 Mar 2016.
- Background: PubMed 23732258Guner A, Boz A, Ozkan OF, Ileli O, Kece C, Reis E. Limberg flap versus Bascom cleft lift techniques for sacrococcygeal pilonidal sinus: prospective, randomized trial. World J Surg. 2013 Sep;37(9):2074-80. doi: 10.1007/s00268-013-2111-9.
- Background: PubMed 23581906Guner A, Ozkan OF, Kece C, Kesici S, Kucuktulu U. Modification of the Bascom cleft lift procedure for chronic pilonidal sinus: results in 141 patients. Colorectal Dis. 2013 Jul;15(7):e402-6. doi: 10.1111/codi.12243.
- Background: PubMed 17434365Bascom J, Bascom T. Utility of the cleft lift procedure in refractory pilonidal disease. Am J Surg. 2007 May;193(5):606-9; discussion 609. doi: 10.1016/j.amjsurg.2007.01.008.
- Background: PubMed 17899165Mentes O, Bagci M, Bilgin T, Ozgul O, Ozdemir M. Limberg flap procedure for pilonidal sinus disease: results of 353 patients. Langenbecks Arch Surg. 2008 Mar;393(2):185-9. doi: 10.1007/s00423-007-0227-9. Epub 2007 Sep 22.
- Background: PubMed 20122682Can MF, Sevinc MM, Hancerliogullari O, Yilmaz M, Yagci G. Multicenter prospective randomized trial comparing modified Limberg flap transposition and Karydakis flap reconstruction in patients with sacrococcygeal pilonidal disease. Am J Surg. 2010 Sep;200(3):318-27. doi: 10.1016/j.amjsurg.2009.08.042. Epub 2010 Feb 1.
- Background: PubMed 16990977Kement M, Oncel M, Kurt N, Kaptanoglu L. Sinus excision for the treatment of limited chronic pilonidal disease: results after a medium-term follow-up. Dis Colon Rectum. 2006 Nov;49(11):1758-62. doi: 10.1007/s10350-006-0676-1.
- Derived from this study: PubMed 27084534Guner A, Cekic AB, Boz A, Turkyilmaz S, Kucuktulu U. A proposed staging system for chronic symptomatic pilonidal sinus disease and results in patients treated with stage-based approach. BMC Surg. 2016 Apr 16;16:18. doi: 10.1186/s12893-016-0134-5.
- Individual participant dataSharing planned: No. because this is retrospective study.
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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?
An observational study of Pilonidal Sinus, run by Trabzon Numune Training and Research Hospital.
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 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: finished, as of the sponsor's last update on 18 Mar 2016. 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?
Early wound complications (time frame: up to 3 months). 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 NCT02712970, which also lists 7 linked publications.
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 Mar 2016.