Pilonidal SinusGLUENCT03914729
GLUtEus Maximus Fascia Plasty Flap for Pilonidal Sinus
A study testing Primary Closure and Gluteus Maximus Fascia Plasty Flap in people with Pilonidal Sinus, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
Trial summary
Surgical treatment is still gold standard for pilonidal sinus disease. Several surgical techniques have been proposed to treat this disease in the last two decades. A new method - midline excision of pilonidal sinus and wound closure using gluteus maximus fascia plasty flap (GMFF) - was proposed recently as a new… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- Primary Closure and Gluteus Maximus Fascia Plasty Flap
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteRussia
- Study dates
- 20 Apr 2017to 30 Dec 2024
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent
- Chronic primary or recurrent pilonidal sinus at the remission stage.
- Presence or absence of secondary orifices.
- Planned surgical treatment with excision of pilonidal sinus.
- Location of secondary orifices less than 2 cm from the natal cleft.
- The distance between bilateral symmetrical secondary orifices less than 2 cm.
Show all 13Show fewer
- American Society Anesthesiologists (ASA) score 1 to 3
- Non-inclusion Criteria:
- Acute pilonidal sinus abscess.
- The secondary openings (orifice) position more than 2 cm from the midline.
- ASA 4-5.
- Predictable impossibility of following the protocol.
- Pregnancy
Who cannot join
- 1 The patients lost for the further observation. 2. The patient's refusal to continue participate in the investigation.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical University
Moscow, 119435
Darya + 7-920-520-77-06 Shlyk, MD, + 7-920-520-77-06, shlyk@kkmx.ru
About this study
Official title: Multicenter Randomized Controlled Trial of Mobilized Gluteus Maximus Muscle Fascia Flap Versus Primary Closure in the Treatment of Primary and Recurrent Pilonidal Sinus Disease.
Surgical treatment is still gold standard for pilonidal sinus disease. Several surgical techniques have been proposed to treat this disease in the last two decades. A new method - midline excision of pilonidal sinus and wound closure using gluteus maximus fascia plasty flap (GMFF) - was proposed recently as a new method of treatment that results in low reccurence rate and good cosmetic results.
The aim of this study is to compare a new method (GMFF) with a traditional method (midline excision and primary closure) in terms of recurrence rate, complications and patient satisfaction with results.
Read the detailed description
Pilonidal sinus disease (PSD) is a rather rare benign condition (about 26 cases per 100,000 population) that affects primarily young adults. Because of purulent nature it is treated with surgery only.
Traditional surgical techniques encompass midline excision of the purulent cyst and either leaving the wound "lay open" for secondary closure or midline primary closure. The latter method has a major drawback of high recurrence rate and very long healing and patient disability periods. Therefore alternative techniques to close the wound after pilonidal sinus excision were proposed. In some a muscular-cutaneous flaps are created and the wound is closed in a Z- or Y- or other shape manner. The recurrence rate of these techniques is significantly lower than with a traditional midline closure, but healing time and final cosmetic results are far from ideal in patient view.
Recently a new method of wound closure was developed independently by a few groups that includes bilateral mobilisation of gluteus maximus muscles fascia and midline closure of the wound. Preliminary results demonstrated that this method leads to lower recurrence rate and better cosmetic results because the natal cleft is saved.
- Conditions
- Pilonidal Sinus
- Being tested
- Primary Closure, Gluteus Maximus Fascia Plasty Flap
- Keywords
- pilonidal sinus, plasty, gluteus muscle fascia, ano-coccygeal plasty
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary ClosureProcedure or surgery
A symmetrical elliptical incision of skin and subcutaneous fat around primary and secondary orifices is performed. The cyst is excised en bloc down to the sacral fascia and removed. The lateral edges of the wound are approximated and sutured in the midline: subcutaneous fat - with a running suture, skin - with a separate running suture.
Gluteus Maximus Fascia Plasty FlapProcedure or surgery
A symmetrical elliptical incision of skin and subcutaneous fat around primary and secondary orifices is performed. The cyst is excised en bloc down to the sacral fascia and removed. The lateral edges of the gluteus maximus muscles fascia bilaterally are mobilised in the direction from the fixation point to the sacrum and for 3-4 cm in lateral direction. The fascia flaps edges are approximated and fixed in the midline with a running suture. The subcutaneous fat is closed with a running suture, skin is closed with a separate running suture.
| Study group | Role | What they receive |
|---|---|---|
| Primary Closure | Active comparator | After pilonidal sinus is excised, subcutaneous fat and skin are closed in midline with a running suture Receives: Procedure: Primary Closure |
| Gluteus Maximus Plasty Flap | Active comparator | After pilonidal sinus is excised, gluteus maximus fascia flaps will be mobilised, approximated in the midline and fixed with a running suture. Subcutaneous fat and skin are closed in midline with a running suture. Receives: Procedure: Gluteus Maximus Fascia Plasty Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
The rate of disease recurrence (clinical picture of pilonidal sinus and/or appearance of new openings in the intergluteal cleft and/or chronic unhealing wound and/or residual cavity in the wound area as confirmed by the soft tissue ultrasound)
Measured: starting from 6 months after surgery and up to 5 years after surgery
Secondary outcomes (13)
Operative time
The length of surgery in minutes
Measured: 1 day
Bloodloss
The amount of blood lost during surgery
Measured: 1 day
Postoperative pain intensity - early postoperative period
Pain intensity will be evaluated twice a day (in the morning and in the evening) with a patient-reported Visual Analog Scale (VAS) that ranges from 0 to 10 with 0 representing no pain and 10 representing intolerable pain. A total score will be recorded.
Measured: On 1st, 3rd, 5th and 7th postoperative day
Postoperative pain intensity - late postoperative period
Pain intensity will be evaluated once a day with a patient-reported Visual Analog Scale (VAS) that ranges from 0 to 10 with 0 representing no pain and 10 representing intolerable pain. A total score will be recorded.
Measured: On 10th, 14th, 21st, 30 day after surgery
Surgical site infection rate
The rate of infectious inflammation of the wound as confirmed by the observing doctor
Measured: 3 month after surgery
Inhospital stay
The duration of treatment after surgery untill discharge from the hospital (in days)
Measured: 30 days
Wound hemorrhage rate
The rate of hemorrhage from wound edges
Measured: Within 30 days from surgery
Wound seroma rate
The rate of seroma detection in the wound area as confirmed by soft tissues ultrasound
Measured: 90 days after surgery
Wound healing rate
The proportion of patients having their wound completely healed
Measured: 6 months after surgery
Wound healing speed
The time period between surgery and complete healing of the wound
Measured: 5 years after surgery
Secondary surgery rate
The rate of surgical procedures after initial surgery performed for recurrent disease and/or wound complications
Measured: 5 years
Patient satisfaction with cosmetic results
Patient-reported with a scale 0-10, where 0 corresponds to "completely unsatisfactory" and 10 corresponds to "completely satisfactory". A total score is registered.
Measured: 6 months, 1 year, 3 years, 5 years after surgery
Overall quality of life
Assessed with patient-reported questionnaire SF-36. A total score in each of 8 sections will be calculated and transformed into a 0-100 scale with a score of zero equivalent to maximum disability and a score of 100 equivalent to no disability
Measured: 1-7 days before surgery, 1 month, 3 months, 1 year, 3 years, 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start20 Apr 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multi-centre, parallel-arm randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Society of Colorectal Surgeons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inna Tulina, PhD, Principal investigator, I.M. Sechenov First Moscow State Medical UniversityPetr Tsarkov, Prof., Study director, Russian Society of Colorectal Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914729
- Sponsor's protocol ID
- 199323
- Acronym
- GLUE
- Status last verified
- Apr 2019
- First submitted
- 11 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chintapatla S, Safarani N, Kumar S, Haboubi N. Sacrococcygeal pilonidal sinus: historical review, pathological insight and surgical options. Tech Coloproctol. 2003 Apr;7(1):3-8. doi: 10.1007/s101510300001.
PubMed 12750948Sondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. doi: 10.1007/BF00337585.
PubMed 7745322Iesalnieks I, Ommer A, Petersen S, Doll D, Herold A. German national guideline on the management of pilonidal disease. Langenbecks Arch Surg. 2016 Aug;401(5):599-609. doi: 10.1007/s00423-016-1463-7. Epub 2016 Jun 16.
PubMed 27311698Milone M, Velotti N, Manigrasso M, Anoldo P, Milone F, De Palma GD. Long-term follow-up for pilonidal sinus surgery: A review of literature with metanalysis. Surgeon. 2018 Oct;16(5):315-320. doi: 10.1016/j.surge.2018.03.009. Epub 2018 Apr 24.
PubMed 29699781Johnson EK, Vogel JD, Cowan ML, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons' Clinical Practice Guidelines for the Management of Pilonidal Disease. Dis Colon Rectum. 2019 Feb;62(2):146-157. doi: 10.1097/DCR.0000000000001237. No abstract available.
PubMed 30640830
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial of Mobilized Gluteus Maximus Muscle Fascia Flap Versus Primary Closure in the Treatment of Primary and Recurrent Pilonidal Sinus Disease.
- ClinicalTrials.gov ID
- NCT03914729
- Acronym / sponsor ID
- GLUE / 199323
- Conditions
- Pilonidal Sinus
- Keywords
- pilonidal sinus, plasty, gluteus muscle fascia, ano-coccygeal plasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Russian Society of Colorectal SurgeonsUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 16 Apr 2019 (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.
Surgical treatment is still gold standard for pilonidal sinus disease. Several surgical techniques have been proposed to treat this disease in the last two decades. A new method - midline excision of pilonidal sinus and wound closure using gluteus maximus fascia plasty flap (GMFF) - was proposed recently as a new method of treatment that results in low reccurence rate and good cosmetic results.
The aim of this study is to compare a new method (GMFF) with a traditional method (midline excision and primary closure) in terms of recurrence rate, complications and patient satisfaction with results.
Detailed description
Pilonidal sinus disease (PSD) is a rather rare benign condition (about 26 cases per 100,000 population) that affects primarily young adults. Because of purulent nature it is treated with surgery only.
Traditional surgical techniques encompass midline excision of the purulent cyst and either leaving the wound "lay open" for secondary closure or midline primary closure. The latter method has a major drawback of high recurrence rate and very long healing and patient disability periods. Therefore alternative techniques to close the wound after pilonidal sinus excision were proposed. In some a muscular-cutaneous flaps are created and the wound is closed in a Z- or Y- or other shape manner. The recurrence rate of these techniques is significantly lower than with a traditional midline closure, but healing time and final cosmetic results are far from ideal in patient view.
Recently a new method of wound closure was developed independently by a few groups that includes bilateral mobilisation of gluteus maximus muscles fascia and midline closure of the wound. Preliminary results demonstrated that this method leads to lower recurrence rate and better cosmetic results because the natal cleft is saved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, multi-centre, parallel-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Primary Closure | Active comparator | Procedure: Primary ClosureAfter pilonidal sinus is excised, subcutaneous fat and skin are closed in midline with a running suture |
| Gluteus Maximus Plasty Flap | Active comparator | Procedure: Gluteus Maximus Fascia Plasty FlapAfter pilonidal sinus is excised, gluteus maximus fascia flaps will be mobilised, approximated in the midline and fixed with a running suture. Subcutaneous fat and skin are closed in midline with a running suture. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent
- Chronic primary or recurrent pilonidal sinus at the remission stage.
- Presence or absence of secondary orifices.
- Planned surgical treatment with excision of pilonidal sinus.
- Location of secondary orifices less than 2 cm from the natal cleft.
Key exclusion criteria (1 listed)
- 1 The patients lost for the further observation. 2. The patient's refusal to continue participate in the investigation.
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 |
|---|---|---|
| Primary ClosureA symmetrical elliptical incision of skin and subcutaneous fat around primary and secondary orifices is performed. The cyst is excised en bloc down to the sacral fascia and removed. The lateral edges of the wound are approximated and sutured in the midline: subcutaneous fat - with a running suture, skin - with a separate running suture. | Procedure or surgery | Primary Closure |
| Gluteus Maximus Fascia Plasty FlapA symmetrical elliptical incision of skin and subcutaneous fat around primary and secondary orifices is performed. The cyst is excised en bloc down to the sacral fascia and removed. The lateral edges of the gluteus maximus muscles fascia bilaterally are mobilised in the direction from the fixation point to the sacrum and for 3-4 cm in lateral direction. The fascia flaps edges are approximated and fixed in the midline with a running suture. The subcutaneous fat is closed with a running suture, skin is closed with a separate running suture. | Procedure or surgery | Gluteus Maximus Plasty Flap |
Primary outcome
Recurrence rate
Time frame: starting from 6 months after surgery and up to 5 years after surgery
The rate of disease recurrence (clinical picture of pilonidal sinus and/or appearance of new openings in the intergluteal cleft and/or chronic unhealing wound and/or residual cavity in the wound area as confirmed by the soft tissue ultrasound)
13 secondary outcomes
Operative time
Time frame: 1 day
Bloodloss
Time frame: 1 day
Postoperative pain intensity - early postoperative period
Time frame: On 1st, 3rd, 5th and 7th postoperative day
Postoperative pain intensity - late postoperative period
Time frame: On 10th, 14th, 21st, 30 day after surgery
Surgical site infection rate
Time frame: 3 month after surgery
Inhospital stay
Time frame: 30 days
Wound hemorrhage rate
Time frame: Within 30 days from surgery
Wound seroma rate
Time frame: 90 days after surgery
Wound healing rate
Time frame: 6 months after surgery
Wound healing speed
Time frame: 5 years after surgery
Secondary surgery rate
Time frame: 5 years
Patient satisfaction with cosmetic results
Time frame: 6 months, 1 year, 3 years, 5 years after surgery
Overall quality of life
Time frame: 1-7 days before surgery, 1 month, 3 months, 1 year, 3 years, 5 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Results publication: PubMed 12750948Chintapatla S, Safarani N, Kumar S, Haboubi N. Sacrococcygeal pilonidal sinus: historical review, pathological insight and surgical options. Tech Coloproctol. 2003 Apr;7(1):3-8. doi: 10.1007/s101510300001.
- Results publication: PubMed 7745322Sondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. doi: 10.1007/BF00337585.
- Results publication: PubMed 27311698Iesalnieks I, Ommer A, Petersen S, Doll D, Herold A. German national guideline on the management of pilonidal disease. Langenbecks Arch Surg. 2016 Aug;401(5):599-609. doi: 10.1007/s00423-016-1463-7. Epub 2016 Jun 16.
- Results publication: PubMed 29699781Milone M, Velotti N, Manigrasso M, Anoldo P, Milone F, De Palma GD. Long-term follow-up for pilonidal sinus surgery: A review of literature with metanalysis. Surgeon. 2018 Oct;16(5):315-320. doi: 10.1016/j.surge.2018.03.009. Epub 2018 Apr 24.
- Results publication: PubMed 30640830Johnson EK, Vogel JD, Cowan ML, Feingold DL, Steele SR; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons' Clinical Practice Guidelines for the Management of Pilonidal Disease. Dis Colon Rectum. 2019 Feb;62(2):146-157. doi: 10.1097/DCR.0000000000001237. No abstract available.
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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.
Inna Tulina, PhD principal investigator
I.M. Sechenov First Moscow State Medical University
Petr Tsarkov, Prof. study director
Russian Society of Colorectal Surgeons
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Closure and Gluteus Maximus Fascia Plasty Flap in people with Pilonidal Sinus, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
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 13 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 16 Apr 2019. 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 Russia. 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 Darya Shlyk, MD (+ 7-920-520-77-06, shlyk@kkmx.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: starting from 6 months after surgery and up to 5 years after surgery). 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 NCT03914729, which also lists 5 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 16 Apr 2019.