Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Symptoms and General Pathology

Pilonidal Sinus

Paranasal Sinus Diseases

Cysts

Nose Diseases

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Anti-Infective Agents

Blood Substitutes

Coagulants

Micronutrients

Hydrogen Peroxide

Povidone-Iodine

Povidone

Hemostatics

Anti-Infective Agents, Local

Iodine

Cadexomer iodine

Pilonidal sinus is excised, subcutaneous fat and skin are closed in the lateralization with interrupted suture.

Pilonidal sinus is locally excised by dermopunch or scalpel, curettage of the sinus tract with laser destruction

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.

Bascom II procedure

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.

SiLaC

Inna Tulina, PhD

Petr Tsarkov, Prof.

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.

assignment prospective, multi-centre.parallel-arm randomized controlled trial

Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom II Procedure.

Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom

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)

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.

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

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

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

The time period between surgery and complete healing of the wound

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

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

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

Russian Society of Colorectal Surgeons

Infections

Abscess

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Dermatologic Agents

Lidocaine

Anesthetics

Chlorhexidine

Chlorhexidine gluconate

Patients are placed in left-side position. After shaving, cleaning and scrubbing of the skin with alcoholic chlorhexidine, double strong tape is placed on the right buttock in order to increase exposure. Local anaesthesia is administered before incision with 20 ml xylocaine or lidocaine 1-2%. In principle, all sinusoidal pits are cut out with a margin of at least 1 mm with a biopsy core punch (4 mm, 6 mm or 8 mm depending on pit size) or an oval excision of the pits is performed. Hair and debris is removed from the sinus tracts with a small surgical spoon or mosquito clamp. Rigorous de-epithelialisation of the underlying sinus is performed with the spoon through every pit, whilst removing even more debris and hairs. At the end of the procedure a debris washout is performed with saline solution, the wounds are left open for secondary healing and sterile dressings are applied.

Pit-picking surgery

The pit picking procedure is described above. Subsequently, a radial diode laser probe at 1470 nm wavelength is used for delivering homogeneous (360 degrees) energy to the surrounding epithelium. The laser energy is 13 Joule, given continuously. First, a 'preparatory laser treatment' is performed to extract any missed hairs or debris, after which the sinus tracts are cleansed with a surgical spoon again. During the following definitive procedure, the probe is withdrawn at an approximate speed of 1 cm per three seconds, causing the small sinus tracts to shrink and close. Large sinus tracts remain open because very large sinus tracts or cavities cannot be closed with the 3mm laser fibre. The injury to the endothelium will cause granulation and create oedema for collapsing of the tract. The remaining open wounds are left open for secondary healing and sterile dressings are applied.

Pit-picking surgery with Sinus Laser assisted Closure

Justin Youp van Oostendorp, MD MSc

Robert Smeenk, MD PhD

The goal of this randomized clinical trial is to establish the efficacy of 'pit picking with laser therapy' versus 'pit picking alone' on both short and long-term outcomes in patients of 12 years and older with primary pilonidal sinus disease.

The main questions it aims to answer are:

* The overall success rate of treatment which is defined as: closure of all pits at 12 months of follow-up.
* Secondary endpoints: succes rat eof treatment during long-term follow-up, wound closure time, pain scores, complication rate, work rehabilitation, time to return to daily activities, quality of life, persisting complaints, patient satisfaction, costs and the need for secondary or revision surgery.

Participants will allocated to pit picking alone or combined with lasertherapy.

The extra burden for participating patients is expected to be minimal to moderate. Participants will have two extra hospital visits in casethey are enrolled in our study: 6 and 12 months after enrolment. Postoperatively the normal scheme of follow up appointments wil be used: 2 and 6 weeks after treatment at the outpatient clinic of the treating surgeon. A telephone appointment with the researcher will be scheduled 4 weeks after treatment. Patients are asked to complete questionnaires at various time points, which will be sentto them by email and will take approximately 5-10 minutes each time. The content includes general and disease specific Quality of Life (QoL) questionnaires. The investigators do not expect any extra adverse reactions or events in respect to participation in the study because both procedures are considered standard of care in the participating clinics. However, because both interventions are surgical procedures a small percentage of adverse events or postoperative complications can be expected.

Multicentre, single-blinded, randomised, controlled, superiority trial. It

Comparing Minimally Invasive Treatments for Pilonidal Disease: LA POPA Trial (Laser And Pit-picking OR Pit-picking Alone)

Success rate of treatment, defined as closure of all pits at 1 year follow-up. Closure of the pits will be assessed by the treating surgeon by means of an extensive physical examination.

Success rate of treatment at 3 and 5 years follow up

Pain scores in the period after surgery (VAS). VAS score scale: 0-10, higher score meaning a worse outcome.

PROMs, defined as persisting complaints: itching, wound fluid leakage, blood loss, pus, pain, social burden (shame/embarrassment). PROMs will be scored on a scale: 1-5, with a higher score meaning a worse outcome.

Time until return to daily activities; number of days

Recurrence rate at 1, 3 and 5 years of follow-up

Need for seondary or revision surgery for pilonidal disease

Patient satisfaction with treatment (scored on a likert scale 0-10, with a higher score meaning a better outcome)

Quality of life after treatment (Eq-5d-5l; will be converted to Quality adjusted life years (QALYs; range 0-1, with 1 the highest score and the better outcome)

Absence of symptoms at 1-yars follow-up: participants will be asked a dichotomous question during their 1-year follow-up appointment. At that moment, do they feel their symptoms from pilonidal sinus disease are: A) cured or improved when compared with before treatment? or B) unchanged or worse when compared with before treatment?

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom II Procedure.	NCT05715983	Pilonidal Disea...	Bascom II proce... SiLaC	18 Years -	Russian Society of Colorectal Surgeons
Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom II Procedure.	NCT05715983	Pilonidal Disea...	Bascom II proce... SiLaC	18 Years -	Russian Society of Colorectal Surgeons
Comparing Minimally Invasive Treatments for Pilonidal Disease: LA POPA Trial (Laser And Pit-picking OR Pit-picking Alone)	NCT06140199	Pilonidal Sinus Pilonidal Disea... Pilonidal Sinus... Pilonidal Disea... Pilonidal Sinus...	Pit-picking sur... Pit-picking sur...	12 Years -	Proctos Kliniek

Spots Global Cancer Trial Database for silac

Every month we try and update this database with for silac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for silac

Every month we try and update this database with for silac cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for silac cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.