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

Russian Society of Colorectal Surgeons

Coagulants

All Drugs and Chemicals

Hemostatics

Excision of sinus and paramedian closure according to modified Karydakis technique

Removal / fistulectomy by scalpels or trephines of primary and drainage orifices and healing of the wound by second intention

Asymmetric skin incision and total excision of the lesion with monopolar scalpel. Accurate hemostasis, creation of a cutaneous-subcutaneous flap, primary closure with non-absorbable sutures, optional aspiration drainage.

Primary closure

Evaluation of the cavity using a 0.5-1 mm metal probe which will be inserted into the skin orifice. Excision of the skin around the orifice and debridement/excision of the cavity by monopolar scalpel or Trephines

Fistulectomy

This study wants to improve patient care affected by pilonidal sinus during and after surgery. Pilonidal sinus excision is a frequent procedure, despite this, there is still not an appropriate surgical technique because of a lack of quality comparative studies.

This is a randomized controlled trial. The study will compare the healing of the surgical wound and the recurrence rate after excision and primary para-median closure versus narrow orifice excision (fistulectomy)

Group A: excision and paramedian closure according to modified Karydakis technique

Group B: removal / fistulectomy by scalpels or trephines of primary and drainage orifices, healing of the wound by secondary intention

Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus

Two Surgical Techniques for the Treatment of Pilinidal Sinus: A Randomized Controlled Trial

Dimitri Christoforidis

Vice-Chief in Surgery

The group in which the pits location were in midline ,underwent excision with primary closure

in which more lateral pits and pits located \<2cm from mid line natal cleft

in which more lateral pits and pits located \>2cm from mid line natal cleft

surgery with primary closure, Rhomboid flap , or Rotational flap

surgery

Sacrococcygeal pilonidal disease (PND) is a common entity affecting the skin and subcutaneous tissue of the upper portion of the natal cleft of the buttocks. It is characterized by the presence of sinus tracts with recurrent inflammation and infection. It poses a significant healthcare problem due to its related morbidity, impaired quality of life, and financial costs.

This acquired disease is caused by negative suction of the hair present in the natal cleft region, leading to a foreign body reaction and subsequent granuloma . It affects 26 per 100000 people, and it mainly affects young men . Surgery for PND is frequently performed in Egypt by general surgeons, with no published data regarding its incidence or prevalence in the Egyptian population.

The PND patient may report different presentations ranging from asymptomatic disease to acute infection and abscess formation. Others may have a chronic disease with recurrent perianal inflammation and discharge.

Multiple surgical options have been described for chronic PND. However, no technique has been universally accepted. The idea of any procedure is to excise the pits with the related sinus tracts leaving healthy tissue as possible to decrease recurrence. The most commonly performed surgical techniques include excision with either primary closure, lay open, or flap-based reconstruction.

A Single Center Experience in the Management of Pilonidal Disease

A Single Center Experience in the Management of Pilonidal Disease; the Impact of Pits Location on the Choice of the Best Surgical Option.

best surgical option based on pits location

Mansoura University

Lecturer of general surgery

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Biological mesh reconstruction of the pelvic floor after extralevator abdomino perineal resection

Primary perineal closure after extralevator abdomino perineal resection

The eAPR procedure will be performed in an identical way as described for the control arm of the study, and this is preferably followed by an omental plasty. The intervention in the experimental arm consists of suturing an acellular biological mesh derived from porcine dermis in the pelvic floor defect (Strattice™, 6x10 cm). The mesh will be sutured at each side of the coccyx or distal sacrum with Prolene or PDS to the discretion of the surgeon. Laterally, the mesh is attached to the remainings of the levator complex and, anteriorly, to the transverse perineal muscle or posterior vaginal wall. A suction drain will be inserted and positioned on top of the mesh. The perineal subcutaneous fat and skin will be subsequently closed in layers similar to primary simple closure as performed in the standard arm.

Biological mesh assisted perineal closure

The perineal phase of the APR will be performed according to the principles of an extralevator APR, which means that the levator muscles will be laterally transected in order to leave a muscular cuff around the tumour. The coccyx will not be routinely resected, but only if indicated based on surgical exposure or oncological principles. The extent of excision of perineal skin and ischioanal fat will be as limited as oncologically justified. Preferably, an omental plasty is positioned in the pelvic cavity following resection. Closure of the perineum in the control arm consists of stitching the perineal subcutaneous fat together using interrupted Vicryl sutures in one or two layers. Subsequently, the skin will be closed using interrupted sutures according to the preference of the surgeon. Placement of a transabdominal or transperineal drain will be at the discretion of the surgeon.

Primary perineal closure

Gijsbert D. Musters, M.D.

Willem A. Bemelman, Prof, PhD, M.D.

Harm J. Rutten, M.D. PhD

Baljit Singh, M.D. PhD

Marcel G.W. Dijkgraaf, M.D.

Rationale: Approximately 800 abdominoperineal resections (APR) are performed for rectal cancer each year in the Netherlands. The extralevator approach (eAPR) reduces the rate of positive margins and improves oncological outcome in distal rectal cancer. However, wider excisions increase wound healing problems and development of perineal hernia. This has resulted in a progressive increase of the use of musculocutaneous flaps and biological meshes associated with a substantial increase of costs, which is not supported by proper data.

Objective: The aim of this study is to determine the cost-effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy.

Study design: This is a multicenter study in which patients undergoing an eAPR are randomized between standard care using primary closure of the perineum and the experimental arm with assisted closure using a biological mesh.

Study population: Patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy. A total number of 104 patients will be randomized.

Intervention: The intervention in the experimental arm consists of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm.

Main study parameters/endpoints: The primary endpoint is the percentage of uncomplicated perineal wound healing (Souphampton wound score less than II at day 30). Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both primary perineal closure and biological mesh assisted closure are being performed in daily clinical practise. The potential benefit resulting from participation of the study in patients randomized for biological mesh assisted closure may be a higher chance of uncomplicated perineal wound healing and lower perineal hernia rate. On the other hand, the use of a biological mesh has been associated with increased postoperative pain and seroma formation.

Biological Mesh Closure of the Pelvic Floor After Extralevator Abdomino Perineal Resection for Rectal Cancer

Long-term Results of Biological Mesh Closure of the Pelvic Floor After Extralevator Abdominoperineal Resection for Rectal Cancer

uncomplicated perineal wound healing is defined as a Souphampton wound score less than II

LifeCell

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Biological mesh reconstruction of the pelvic floor after extralevator abdomino perineal resection

Biological mesh assisted perineal closure: The eAPR procedure will be performed in an identical way as described for the control arm of the study, and this is preferably followed by an omental plasty. The intervention in the experimental arm consists of suturing an acellular biological mesh derived from porcine dermis in the pelvic floor defect (Strattice™, 6x10 cm). The mesh will be sutured at each side of the coccyx or distal sacrum with Prolene or PDS to the discretion of the surgeon. Laterally, the mesh is attached to the remainings of the levator complex and, anteriorly, to the transverse perineal muscle or posterior vaginal wall. A suction drain will be inserted and positioned on top of the mesh. The perineal subcutaneous fat and skin will be subsequently closed in layers similar to primary simple closure as performed in the standard arm.

Biological Mesh Closure

Primary perineal closure after extralevator abdomino perineal resection

Primary perineal closure: The perineal phase of the APR will be performed according to the principles of an extralevator APR, which means that the levator muscles will be laterally transected in order to leave a muscular cuff around the tumour. The coccyx will not be routinely resected, but only if indicated based on surgical exposure or oncological principles. The extent of excision of perineal skin and ischioanal fat will be as limited as oncologically justified. Preferably, an omental plasty is positioned in the pelvic cavity following resection. Closure of the perineum in the control arm consists of stitching the perineal subcutaneous fat together using interrupted Vicryl sutures in one or two layers. Subsequently, the skin will be closed using interrupted sutures according to the preference of the surgeon. Placement of a transabdominal or transperineal drain will be at the discretion of the surgeon.

Primary Perineal Closure

Total

Age, Continuous

Sex: Female, Male

there were 2 drop-outs in the biological mesh group because no extralevator APR was performed, and 1 drop-out in the primary closure group because patient died preoperatively because of brain metastasis

prof. dr. P.J. Tanis

2 drop-outs in the biological mesh group and 1 drop-out in de primary perineal closure group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
GLUtEus Maximus Fascia Plasty Flap for Pilonidal Sinus	NCT03914729	Pilonidal Sinus	Primary Closure Gluteus Maximus...	16 Years - 70 Years	Russian Society of Colorectal Surgeons
Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus	NCT03271996	Pilonidal Sinus	Primary closure Fistulectomy	16 Years -	Ente Ospedaliero Cantonale, Bellinzona
A Single Center Experience in the Management of Pilonidal Disease	NCT05892198	Pilonidal Sinus	surgery	18 Years - 60 Years	Mansoura University
A Single Center Experience in the Management of Pilonidal Disease	NCT05892198	Pilonidal Sinus	surgery	18 Years - 60 Years	Mansoura University
Biological Mesh Closure of the Pelvic Floor After Extralevator Abdomino Perineal Resection for Rectal Cancer	NCT01927497	Rectal Cancer	Biological mesh... Primary perinea...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
GLUtEus Maximus Fascia Plasty Flap for Pilonidal Sinus	NCT03914729	Pilonidal Sinus	Primary Closure Gluteus Maximus...	16 Years - 70 Years	Russian Society of Colorectal Surgeons
Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus	NCT03271996	Pilonidal Sinus	Primary closure Fistulectomy	16 Years -	Ente Ospedaliero Cantonale, Bellinzona

Spots Global Cancer Trial Database for primary closure