Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom II Procedure. (SI-BAS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pilonidal Disease
• Intervention / Treatment: Procedure: Bascom II procedure; Procedure: SiLaC

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 Type: Interventional
• Enrollment (Anticipated): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119435
    • Sechenov University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Written informed consent
2. Chronic primary or recurrent pilonidal sinus at the remission stage.
3. Presence or absence of secondary orifices.
4. Planned surgical treatment with excision of pilonidal sinus.
5. Location of the orifices should not be less than 1 cm.
6. Location of secondary orifices less 2 cm from the natal cleft.
7. Distance between bilateral symmetrical positions of secondary orifices should not be more than 2 cm.
8. 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.
9. Sinus diameter (width) in the greatest dimension should not exceed 3 cm, according to the ultrasound of the soft tissues of the sacrococcygeal region.
10. Sinus must be located directly under the skin, according to the ultrasound findings.

11. 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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Bascom II procedure; Pilonidal sinus is excised, subcutaneous fat and skin are closed in the lateralization with interrupted suture.	Procedure: Bascom II procedure; 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.
ACTIVE_COMPARATOR: Sinus Laser Closer (SiLaC); Pilonidal sinus is locally excised by dermopunch or scalpel, curettage of the sinus tract with laser destruction	Procedure: SiLaC; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	starting from 6 months after surgery and up to 3 years after surgery]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	The length of surgery in minutes	1 day
Bloodloss	The amount of blood lost during surgery	1 day
Wound seroma rate	The rate of seroma detection in the wound area as confirmed by soft tissues ultrasound	90 days after 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.	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.	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	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	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	3 years after surgery
Wound healing speed	The time period between surgery and complete healing of the wound	3 years after surgery
Wound hemorrhage rate	The rate of hemorrhage from wound edges	Within 30 days from 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.	6 months, 1 year, 3 years
Inhospital stay	The duration of treatment after surgery until discharge from the hospital (in days)	30 days]

Collaborators and Investigators

• Sponsor: Russian Society of Colorectal Surgeons
• Investigators: Principal Investigator: Inna Tulina, PhD, I.M. Sechenov First Moscow State Medical University, Moscow, Russia, 119435; Study Director: Petr Tsarkov, Prof., I.M. Sechenov First Moscow State Medical University Moscow, Russia, 119435

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 8, 2022
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): January 31, 2025

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Bascom II, SiLaC, Sinus Laser Closer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Cysts; Otorhinolaryngologic Diseases; Nose Diseases; Pilonidal Sinus; Paranasal Sinus Diseases
• Other Study ID Numbers: 25-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No