Pilonidal DiseaseSI-BASNCT05715983
Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom II Procedure.
A study testing Bascom II procedure and SiLaC in people with Pilonidal Disease, run by Russian Society of Colorectal Surgeons at 1 site in Russia.
Trial summary
Surgical treatment witn lateralization of intergluteal cleft is still gold standard for pilonidal sinus disaease. But nowadays minimally invasive treatment methods such as the use of a diode laser (SiLac, Sinus Laser Closure) to obliterate the coccygeal tract are used more often. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Disease
- What is being tested?
- Bascom II procedure and SiLaC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteRussia
- Study dates
- 8 Dec 2022to 31 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- 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 the orifices should not be less than 1 cm.
- Location of secondary orifices less 2 cm from the natal cleft.
Show all 14Show fewer
- Distance between bilateral symmetrical positions of secondary orifices should not be more than 2 cm.
- Length of the sinus in the greatest dimension, according to the ultrasound of the soft tissue of the sacrococcygeal region, should not exceed 7 cm.
- Sinus diameter (width) in the greatest dimension should not exceed 3 cm, according to the ultrasound of the soft tissues of the sacrococcygeal region.
- Sinus must be located directly under the skin, according to the ultrasound findings.
- Lack of fixation of the cavity to the coccyx, when evaluating data on pelvic contrast-enhanced magnetic resonance imaging (MRI)
- Non-inclusion criteria
- 1. Acute pilonidal sinus abscess 2. The secondary openings (orifice) position more than 3 cm from the midline. 3. Length of the cavity in the greatest dimension, according to the results of ultrasound examination, exceeds 6 cm 4. Width (diameter) of the sinus in the greatest dimension, according to the results of the ultrasound, more than 3 cm.
- 5. ASA > III. 6. Predictable impossibility of following the protocol 7. Pregnancy
Who cannot join
- 1. The patients lost for the follow-up 2. The patient's refusal to continue participate in the investigation. 3. Impossibility of the operation performing in the planned scope
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom
Surgical treatment witn lateralization of intergluteal cleft is still gold standard for pilonidal sinus disaease. But nowadays minimally invasive treatment methods such as the use of a diode laser (SiLac, Sinus Laser Closure) to obliterate the coccygeal tract are used more often. The aim of the study is to compare a new minimal invasive method (laser treatment) with traditional method ( Bascom II) in terms of recurrence rate, complications and patients satisfaction with results.
Read the detailed description
Pilonidal sinus disease (PSD): is 26 cases per 100,000 population, affects primarily young adults. One of the problems of surgical treatment of PSD is the frequent development of recurrence. There are various methods of surgical treatment, but the recurrence rate still high up to 67%.
Nowadays, minimally invasive methods for PSD (e.g. the use of a diode laser for sinus obliteration- SiLac, Sinus Laser Closure) compete with traditional methods. This "day-surgery" method significantly reduces the risk of postoperative complications, allows a quicker return to normal daily activity, preserves the intergluteal cleft and provides the best cosmetic results. According to some authors, the recurrence rate in this method is up to 26%, parallel others- recurrence rate is less 3 %, but the follow-up does not exceed 2 years.
On the other hand, the excision of the PSD with the mobilization of the skin-subcutaneous flap, which leads to the lateralization of the postoperative scar to one side of the intergluteal cleft hereby providing a low recurrence rate (up to 4%) .
Thus, despite the increased use of minimally invasive surgery, excision of the pilonidal sinus disease cannot be undoubtedly abandoned due to the lack of comparative studies.
- Conditions
- Pilonidal Disease
- Being tested
- Bascom II procedure, SiLaC
- Keywords
- Bascom II, SiLaC, Sinus Laser Closer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bascom II procedureProcedure or surgery
Buttocks are strapped apart with wide adhesive tape. The area is prepared using antiseptic solution twice. Solution of brilliant green with 3% hydrogen peroxide was injected in all orifices to visualize all tracts and sinuses. The proposal area of incision is marked nearby sinus tract openings and the skin with lateralization on one side of the cleft. A vertical-orientated incision of the skin and subcutaneous fat around the primary and secondary orifices is made using a scalpel or a monopolar electrocautery. The sinus tract is excised in en-block till unchanged subcutaneous tissue. The wound is irrigated with antiseptic solution. If postoperative wound is larger than 5 cm then a silicone draining tube is placed through the contraperature in the upper corner. The wound is closed by interrupted sutures Vicryl/Polysorb 2/0 3/0 layer by layer. Aseptic dressing is applied to the closed wound.
SiLaCProcedure or surgery
Buttocks are strapped apart with wide adhesive tape. The area is prepared using antiseptic solution twice. Solution of brilliant green with 3% hydrogen peroxide is injected in all orifices to visualize all tracts and sinuses. All visible orifices are excised with a scalpel or dermo punch. After that hairs are removed from the sinus by Volkmann curette. A metallic stylet is used to determine the length and direction of the different tracts. Then laser destruction of the sinus is performed with FiberLase VT laser, wavelength 1460 or 1520 nm, the laser energy 10-12 Watts. The fiber delivers energy homogeneously in a continuous way. Hemostasis by electrocautery. The wound is washed with povidone-iodine solution. Aseptic dressing is applied.
| Study group | Role | What they receive |
|---|---|---|
| Bascom II procedure | Active comparator | Pilonidal sinus is excised, subcutaneous fat and skin are closed in the lateralization with interrupted suture. Receives: Procedure: Bascom II procedure |
| Sinus Laser Closer (SiLaC) | Active comparator | Pilonidal sinus is locally excised by dermopunch or scalpel, curettage of the sinus tract with laser destruction Receives: Procedure: SiLaC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reccurance rate
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 3 years after surgery]
Secondary outcomes (12)
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: Frame: 3 month after surgery
Overall quality of life
Assessed with patient-reported questionnaire SF-12. 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 after surgery, 1 month, 3 months, 1 year, 3 years, 5 years after surgery
Secondary surgery rate
The rate of surgical procedures after initial surgery performed for recurrent disease and/or wound complications
Measured: 3 years after surgery
Wound healing speed
The time period between surgery and complete healing of the wound
Measured: 3 years after surgery
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
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
Inhospital stay
The duration of treatment after surgery until discharge from the hospital (in days)
Measured: 30 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start8 Dec 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pilonidal DiseaseStudies 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
- assignment prospective, multi-centre.parallel-arm randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Society of Colorectal Surgeons
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darya Shlyk, Russian Society of Colorectal Surgeons
- Investigators
- Inna Tulina, PhD, Principal investigator, I.M. Sechenov First Moscow State Medical University, Moscow, Russia, 119435Petr Tsarkov, Prof., Study director, I.M. Sechenov First Moscow State Medical University Moscow, Russia, 119435
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715983
- Sponsor's protocol ID
- 25-22
- Acronym
- SI-BAS
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom
- ClinicalTrials.gov ID
- NCT05715983
- Acronym / sponsor ID
- SI-BAS / 25-22
- Conditions
- Pilonidal Disease
- Keywords
- Bascom II, SiLaC, Sinus Laser Closer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Russian Society of Colorectal SurgeonsUniversity, hospital or other
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 8 Feb 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.
Surgical treatment witn lateralization of intergluteal cleft is still gold standard for pilonidal sinus disaease. But nowadays minimally invasive treatment methods such as the use of a diode laser (SiLac, Sinus Laser Closure) to obliterate the coccygeal tract are used more often. The aim of the study is to compare a new minimal invasive method (laser treatment) with traditional method ( Bascom II) in terms of recurrence rate, complications and patients satisfaction with results.
Detailed description
Pilonidal sinus disease (PSD): is 26 cases per 100,000 population, affects primarily young adults. One of the problems of surgical treatment of PSD is the frequent development of recurrence. There are various methods of surgical treatment, but the recurrence rate still high up to 67%.
Nowadays, minimally invasive methods for PSD (e.g. the use of a diode laser for sinus obliteration- SiLac, Sinus Laser Closure) compete with traditional methods. This "day-surgery" method significantly reduces the risk of postoperative complications, allows a quicker return to normal daily activity, preserves the intergluteal cleft and provides the best cosmetic results. According to some authors, the recurrence rate in this method is up to 26%, parallel others- recurrence rate is less 3 %, but the follow-up does not exceed 2 years.
On the other hand, the excision of the PSD with the mobilization of the skin-subcutaneous flap, which leads to the lateralization of the postoperative scar to one side of the intergluteal cleft hereby providing a low recurrence rate (up to 4%) .
Thus, despite the increased use of minimally invasive surgery, excision of the pilonidal sinus disease cannot be undoubtedly abandoned due to the lack of comparative studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- assignment prospective, multi-centre.parallel-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Bascom II procedure | Active comparator | Procedure: Bascom II procedurePilonidal sinus is excised, subcutaneous fat and skin are closed in the lateralization with interrupted suture. |
| Sinus Laser Closer (SiLaC) | Active comparator | Procedure: SiLaCPilonidal sinus is locally excised by dermopunch or scalpel, curettage of the sinus tract with laser destruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 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 the orifices should not be less than 1 cm.
Key exclusion criteria (2 listed)
- 1. The patients lost for the follow-up 2. The patient's refusal to continue participate in the investigation. 3. Impossibility of the operation performing in the planned scope
- -
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 |
|---|---|---|
| Bascom II procedureButtocks are strapped apart with wide adhesive tape. The area is prepared using antiseptic solution twice. Solution of brilliant green with 3% hydrogen peroxide was injected in all orifices to visualize all tracts and sinuses. The proposal area of incision is marked nearby sinus tract openings and the skin with lateralization on one side of the cleft. A vertical-orientated incision of the skin and subcutaneous fat around the primary and secondary orifices is made using a scalpel or a monopolar electrocautery. The sinus tract is excised in en-block till unchanged subcutaneous tissue. The wound is irrigated with antiseptic solution. If postoperative wound is larger than 5 cm then a silicone draining tube is placed through the contraperature in the upper corner. The wound is closed by interrupted sutures Vicryl/Polysorb 2/0 3/0 layer by layer. Aseptic dressing is applied to the closed wound. | Procedure or surgery | Bascom II procedure |
| SiLaCButtocks are strapped apart with wide adhesive tape. The area is prepared using antiseptic solution twice. Solution of brilliant green with 3% hydrogen peroxide is injected in all orifices to visualize all tracts and sinuses. All visible orifices are excised with a scalpel or dermo punch. After that hairs are removed from the sinus by Volkmann curette. A metallic stylet is used to determine the length and direction of the different tracts. Then laser destruction of the sinus is performed with FiberLase VT laser, wavelength 1460 or 1520 nm, the laser energy 10-12 Watts. The fiber delivers energy homogeneously in a continuous way. Hemostasis by electrocautery. The wound is washed with povidone-iodine solution. Aseptic dressing is applied. | Procedure or surgery | Sinus Laser Closer (SiLaC) |
Primary outcome
Reccurance rate
Time frame: starting from 6 months after surgery and up to 3 years after surgery]
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)
12 secondary outcomes
Operative time
Time frame: 1 day
Bloodloss
Time frame: 1 day
Postoperative pain intensity
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: Frame: 3 month after surgery
Overall quality of life
Time frame: 1- 7 days after surgery, 1 month, 3 months, 1 year, 3 years, 5 years after surgery
Secondary surgery rate
Time frame: 3 years after surgery
Wound healing speed
Time frame: 3 years after surgery
Wound hemorrhage rate
Time frame: Within 30 days from surgery]
Wound seroma rate
Time frame: 90 days after surgery
Patient satisfaction with cosmetic results
Time frame: 6 months, 1 year, 3 years
Inhospital stay
Time frame: 30 days]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 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.
Inna Tulina, PhD principal investigator
I.M. Sechenov First Moscow State Medical University, Moscow, Russia, 119435
Petr Tsarkov, Prof. study director
I.M. Sechenov First Moscow State Medical University Moscow, Russia, 119435
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bascom II procedure and SiLaC in people with Pilonidal Disease, 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 14 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?
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?
Reccurance rate (time frame: starting from 6 months after surgery and up to 3 years after surgery]). 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 8 Feb 2023.