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

NANot yet recruitingINTERVENTIONAL
Enrollment

482

Participants

Timeline

Start Date

August 28, 2024

Primary Completion Date

May 31, 2027

Study Completion Date

May 31, 2032

Conditions
Pilonidal SinusPilonidal DiseasePilonidal Sinus of Natal CleftPilonidal Disease of Natal CleftPilonidal Sinus Without Abscess
Interventions
PROCEDURE

Pit-picking surgery

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.

PROCEDURE

Pit-picking surgery with Sinus Laser assisted Closure

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 During the following definitive procedure, the probe is withdrawn at an approximate speed of 1 cm per three seconds, causing the small sinus tracts to shrink and close.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.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Flevoziekenhuis

OTHER

collaborator

Proctos Kliniek

OTHER

collaborator

Sint Jans Gasthuis Weert

UNKNOWN

collaborator

UMC Utrecht

OTHER

collaborator

Ziekenhuis Amstelland

OTHER

collaborator

Treant ziekenhuis

UNKNOWN

collaborator

Albert Schweitzer Hospital

OTHER

lead

dr. IJM Han-Geurts

OTHER

NCT06140199 - Comparing Minimally Invasive Treatments for Pilonidal Disease: LA POPA Trial (Laser And Pit-picking OR Pit-picking Alone) | Biotech Hunter | Biotech Hunter