Back to resultsComparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom II Procedure. (SI-BAS)
Primary Purpose
Pilonidal Disease
Status
Active
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Bascom II procedure
SiLaC
Sponsored by
About this trial
This is an interventional treatment trial for Pilonidal Disease focused on measuring Bascom II, SiLaC, Sinus Laser Closer
Eligibility Criteria
Inclusion Criteria: 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. 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 _____ Exclusion criteria 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 -
Sites / Locations
- Sechenov University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bascom II procedure
Sinus Laser Closer (SiLaC)
Arm Description
Pilonidal sinus is excised, subcutaneous fat and skin are closed in the lateralization with interrupted suture.
Pilonidal sinus is locally excised by dermopunch or scalpel, curettage of the sinus tract with laser destruction
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Operative time
The length of surgery in minutes
Bloodloss
The amount of blood lost during surgery
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.
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.
Surgical site infection rate
The rate of infectious inflammation of the wound as confirmed by the observing doctor
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
Secondary surgery rate
The rate of surgical procedures after initial surgery performed for recurrent disease and/or wound complications
Wound healing speed
The time period between surgery and complete healing of the wound
Wound hemorrhage rate
The rate of hemorrhage from wound edges
Wound seroma rate
The rate of seroma detection in the wound area as confirmed by soft tissues ultrasound
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.
Inhospital stay
The duration of treatment after surgery until discharge from the hospital (in days)
Full Information
NCT ID
NCT05715983
First Posted
January 27, 2023
Last Updated
January 27, 2023
Sponsor
Russian Society of Colorectal Surgeons
1. Study Identification
Unique Protocol Identification Number
NCT05715983
Brief Title
Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom II Procedure.
Acronym
SI-BAS
Official Title
Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Russian Society of Colorectal Surgeons
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Disease
Keywords
Bascom II, SiLaC, Sinus Laser Closer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
assignment prospective, multi-centre.parallel-arm randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
double
Allocation
Randomized
Enrollment
164 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bascom II procedure
Arm Type
Active Comparator
Arm Description
Pilonidal sinus is excised, subcutaneous fat and skin are closed in the lateralization with interrupted suture.
Arm Title
Sinus Laser Closer (SiLaC)
Arm Type
Active Comparator
Arm Description
Pilonidal sinus is locally excised by dermopunch or scalpel, curettage of the sinus tract with laser destruction
Intervention Type
Procedure
Intervention Name(s)
Bascom II procedure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
SiLaC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reccurance rate
Description
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)
Time Frame
starting from 6 months after surgery and up to 3 years after surgery]
Secondary Outcome Measure Information:
Title
Operative time
Description
The length of surgery in minutes
Time Frame
1 day
Title
Bloodloss
Description
The amount of blood lost during surgery
Time Frame
1 day
Title
Postoperative pain intensity
Description
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.
Time Frame
On 1st, 3rd, 5th and 7th postoperative day]
Title
Postoperative pain intensity - late postoperative period
Description
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.
Time Frame
On 10th, 14th, 21st, 30 day after surgery]
Title
Surgical site infection rate
Description
The rate of infectious inflammation of the wound as confirmed by the observing doctor
Time Frame
Frame: 3 month after surgery
Title
Overall quality of life
Description
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
Time Frame
1- 7 days after surgery, 1 month, 3 months, 1 year, 3 years, 5 years after surgery
Title
Secondary surgery rate
Description
The rate of surgical procedures after initial surgery performed for recurrent disease and/or wound complications
Time Frame
3 years after surgery
Title
Wound healing speed
Description
The time period between surgery and complete healing of the wound
Time Frame
3 years after surgery
Title
Wound hemorrhage rate
Description
The rate of hemorrhage from wound edges
Time Frame
Within 30 days from surgery]
Title
Wound seroma rate
Description
The rate of seroma detection in the wound area as confirmed by soft tissues ultrasound
Time Frame
90 days after surgery
Title
Patient satisfaction with cosmetic results
Description
Patient-reported with a scale 0-10, where 0 corresponds to "completely unsatisfactory" and 10 corresponds to "completely satisfactory". A total score is registered.
Time Frame
6 months, 1 year, 3 years
Title
Inhospital stay
Description
The duration of treatment after surgery until discharge from the hospital (in days)
Time Frame
30 days]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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
_____ Exclusion criteria
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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inna Tulina, PhD
Organizational Affiliation
I.M. Sechenov First Moscow State Medical University, Moscow, Russia, 119435
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Petr Tsarkov, Prof.
Organizational Affiliation
I.M. Sechenov First Moscow State Medical University Moscow, Russia, 119435
Official's Role
Study Director
Facility Information:
Facility Name
Sechenov University
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom II Procedure.
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