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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
164
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.
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.
Sechenov University
Moscow, Russia
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)
Time frame: starting from 6 months after surgery and up to 3 years after surgery]
Operative time
The length of surgery in minutes
Time frame: 1 day
Bloodloss
The amount of blood lost during surgery
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 3 years after surgery
Wound healing speed
The time period between surgery and complete healing of the wound
Time frame: 3 years after surgery
Wound hemorrhage rate
The rate of hemorrhage from wound edges
Time frame: Within 30 days from surgery]
Wound seroma rate
The rate of seroma detection in the wound area as confirmed by soft tissues ultrasound
Time frame: 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.
Time frame: 6 months, 1 year, 3 years
Inhospital stay
The duration of treatment after surgery until discharge from the hospital (in days)
Time frame: 30 days]