Pilonidal Sinus
Conditions
Keywords
pilonidal sinus, plasty, gluteus muscle fascia, ano-coccygeal plasty
Brief 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 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.
Interventions
PROCEDUREPrimary Closure
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.
PROCEDUREGluteus Maximus Fascia Plasty Flap
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.
Sponsors
Russian Society of Colorectal Surgeons
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Prospective, multi-centre, parallel-arm randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
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 secondary orifices less than 2 cm from the natal cleft. 6. The distance between bilateral symmetrical secondary orifices less than 2 cm. 7. American Society Anesthesiologists (ASA) score 1 to 3 Non-inclusion Criteria: 1. Acute pilonidal sinus abscess. 2. The secondary openings (orifice) position more than 2 cm from the midline. 3. ASA 4-5. 4. Predictable impossibility of following the protocol. 5. Pregnancy
Exclusion criteria
1 The patients lost for the further observation. 2. The patient's refusal to continue participate in the investigation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bloodloss | 1 day | The amount of blood lost during surgery |
| Postoperative pain intensity - early postoperative period | On 1st, 3rd, 5th and 7th postoperative day | 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 | On 10th, 14th, 21st, 30 day after surgery | 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 | 3 month after surgery | The rate of infectious inflammation of the wound as confirmed by the observing doctor |
| Inhospital stay | 30 days | The duration of treatment after surgery untill discharge from the hospital (in days) |
| Wound hemorrhage rate | Within 30 days from surgery | The rate of hemorrhage from wound edges |
| Operative time | 1 day | The length of surgery in minutes |
| Wound healing rate | 6 months after surgery | The proportion of patients having their wound completely healed |
| Wound healing speed | 5 years after surgery | The time period between surgery and complete healing of the wound |
| Secondary surgery rate | 5 years | The rate of surgical procedures after initial surgery performed for recurrent disease and/or wound complications |
| Patient satisfaction with cosmetic results | 6 months, 1 year, 3 years, 5 years after surgery | Patient-reported with a scale 0-10, where 0 corresponds to completely unsatisfactory and 10 corresponds to completely satisfactory. A total score is registered. |
| Overall quality of life | 1-7 days before surgery, 1 month, 3 months, 1 year, 3 years, 5 years after surgery | 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 |
| Wound seroma rate | 90 days after surgery | The rate of seroma detection in the wound area as confirmed by soft tissues ultrasound |
Countries
Russia
Contacts
Primary ContactDarya Shlyk, MD
Backup ContactArcangelo Picciariello, MD
Outcome results
None listed