Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Recurrence

Pilonidal Sinus

Paranasal Sinus Diseases

Cysts

After pilonidal sinus is excised, subcutaneous fat and skin are closed in midline with a running suture

After pilonidal sinus is excised, gluteus maximus fascia flaps will be mobilised, approximated in the midline and fixed with a running suture. Subcutaneous fat and skin are closed in midline with a running suture.

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.

Primary 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 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.

Gluteus Maximus Fascia Plasty Flap

Darya Shlyk, MD

Arcangelo Picciariello, MD

Darya + 7-920-520-77-06 Shlyk, MD

Inna Tulina, PhD

Petr Tsarkov, Prof.

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.

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.

Prospective, multi-centre, parallel-arm randomized controlled trial

GLUtEus Maximus Fascia Plasty Flap for Pilonidal Sinus

Multicenter Randomized Controlled Trial of Mobilized Gluteus Maximus Muscle Fascia Flap Versus Primary Closure in the Treatment of Primary and Recurrent Pilonidal Sinus Disease.

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)

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.

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.

The rate of infectious inflammation of the wound as confirmed by the observing doctor

The duration of treatment after surgery untill discharge from the hospital (in days)

The rate of seroma detection in the wound area as confirmed by soft tissues ultrasound

The proportion of patients having their wound completely healed

The time period between surgery and complete healing of the wound

The rate of surgical procedures after initial surgery performed for recurrent disease and/or wound complications

Patient-reported with a scale 0-10, where 0 corresponds to "completely unsatisfactory" and 10 corresponds to "completely satisfactory". A total score is registered.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
GLUtEus Maximus Fascia Plasty Flap for Pilonidal Sinus	NCT03914729	Pilonidal Sinus	Primary Closure Gluteus Maximus...	16 Years - 70 Years	Russian Society of Colorectal Surgeons
GLUtEus Maximus Fascia Plasty Flap for Pilonidal Sinus	NCT03914729	Pilonidal Sinus	Primary Closure Gluteus Maximus...	16 Years - 70 Years	Russian Society of Colorectal Surgeons

Spots Global Cancer Trial Database for gluteus muscle fascia