Chronic Sacrococcygeal Pilonidal Sinus
Conditions
Brief summary
Video assisted ablation of pilonidal sinus (VAAPS) is a new endoscopic minimally invasive treatment. In an attempt to validate the effectiveness of the VAAPS, the investigators have designed a comparative study between the conventional and the minimally invasive treatment. Two surgical procedures were evaluated: VAAPS (Experimental group) and conventional excision with a Bascom out-midline closure (Control group).
Interventions
A 5-phases' technique. The 1st phase is to insert the endoscope through the external opening (orifice). In the patients that had more than one opening the lower pit is used for access. The 2nd phase is to identify the sinus cavity and its lateral tracks. The endoscope is advanced along the pathway using slow movements, left/right and up/down. These manoeuvres and the saline solution, used as distension medium, allow the sinus cavity to accommodate the endoscope. Additionally mechanical adhesiolysis with the forceps grasping could be useful. The 3rd phase is to identify the presence of hair and its removal. The 4th phase phase is to obtain complete ablation of sinus cavity. The sinus cavity and its lateral tracks are destroyed with the electrode under continuous direct vision. The 5th phase is to obtain the accurate cleaning of sinus cavity. The saline solution flow allows the elimination of any necrotic material. A Volkmann spoon could be useful to complete the cleaning.
PROCEDUREBascom Cleft lift procedure
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Chronic sacrococcygeal pilonidal sinus
Exclusion criteria
* Absence of consent to the study * Acute abscess
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infection | at 30 days after surgery | Wound infection was defined as redness and/or oedema of the skin and/or discharge. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recurrence | at 1 year after surgery | recurrence was defined when symptoms of the disease recurred after an interval following complete wound healing. |
| return at work | up to 30 days after surgery | — |
| Pain | up to 30 days after surgery | A vas-score scale (0-10) will be used |
| satisfaction | up to six months after surgery | a Vas-score scale (0-10) and a SF\_36 model will be used |
Countries
Italy
Outcome results
None listed