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GLUtEus Maximus Fascia Plasty Flap for Pilonidal Sinus (GLUE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914729
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Russian Society of Colorectal Surgeons

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.


Condition or disease Intervention/treatment Phase
Pilonidal Sinus Procedure: Primary Closure Procedure: Gluteus Maximus Fascia Plasty Flap Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, multi-centre, parallel-arm randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Controlled Trial of Mobilized Gluteus Maximus Muscle Fascia Flap Versus Primary Closure in the Treatment of Primary and Recurrent Pilonidal Sinus Disease.
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2024

Arm Intervention/treatment
Active Comparator: Primary Closure
After pilonidal sinus is excised, subcutaneous fat and skin are closed in midline with a running suture
Procedure: 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 wound are approximated and sutured in the midline: subcutaneous fat - with a running suture, skin - with a separate running suture.

Active Comparator: Gluteus Maximus Plasty Flap
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.
Procedure: Gluteus 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.




Primary Outcome Measures :
  1. Recurrence rate [ Time Frame: 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 Outcome Measures :
  1. Operative time [ Time Frame: 1 day ]
    The length of surgery in minutes

  2. Bloodloss [ Time Frame: 1 day ]
    The amount of blood lost during surgery

  3. Postoperative pain intensity - early postoperative period [ Time Frame: 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.

  4. Postoperative pain intensity - late postoperative period [ Time Frame: 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.

  5. Surgical site infection rate [ Time Frame: 3 month after surgery ]
    The rate of infectious inflammation of the wound as confirmed by the observing doctor

  6. Inhospital stay [ Time Frame: 30 days ]
    The duration of treatment after surgery untill discharge from the hospital (in days)

  7. Wound hemorrhage rate [ Time Frame: Within 30 days from surgery ]
    The rate of hemorrhage from wound edges

  8. Wound seroma rate [ Time Frame: 90 days after surgery ]
    The rate of seroma detection in the wound area as confirmed by soft tissues ultrasound

  9. Wound healing rate [ Time Frame: 6 months after surgery ]
    The proportion of patients having their wound completely healed

  10. Wound healing speed [ Time Frame: 5 years after surgery ]
    The time period between surgery and complete healing of the wound

  11. Secondary surgery rate [ Time Frame: 5 years ]
    The rate of surgical procedures after initial surgery performed for recurrent disease and/or wound complications

  12. Patient satisfaction with cosmetic results [ Time Frame: 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.

  13. Overall quality of life [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914729


Contacts
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Contact: Darya Shlyk, MD + 7-920-520-77-06 shlyk@kkmx.ru
Contact: Arcangelo Picciariello, MD +393492185104 picciariello@kkmx.ru

Locations
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Russian Federation
Clinic of Colorectal and Minimally Invasive Surgery - I.M. Sechenov First Moscow State Medical University Recruiting
Moscow, Russian Federation, 119435
Contact: Darya + 7-920-520-77-06 Shlyk, MD    + 7-920-520-77-06    shlyk@kkmx.ru   
Sponsors and Collaborators
Russian Society of Colorectal Surgeons
Investigators
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Principal Investigator: Inna Tulina, PhD I.M. Sechenov First Moscow State Medical University
Study Director: Petr Tsarkov, Prof. Russian Society of Colorectal Surgeons
Publications of Results:
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Responsible Party: Russian Society of Colorectal Surgeons
ClinicalTrials.gov Identifier: NCT03914729    
Other Study ID Numbers: 199323
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Russian Society of Colorectal Surgeons:
pilonidal sinus
plasty
gluteus muscle fascia
ano-coccygeal plasty
Additional relevant MeSH terms:
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Pilonidal Sinus
Cysts
Neoplasms