Pilonidal Sinus Disease: Preliminare Study

Ospedale di Cavalese

Status: Completed

Conditions: Pilonidal Sinus

Treatments: Procedure: In "hot" group 16 patients were treated by diathermy in "Cold"; Procedure: in "Cold" group 13 patients were treated by scalpel.

Study type: Observational

Funder types: Other

Identifiers

NCT03764657

OCavalese172018

Details and patient eligibility

About

Pilonidal disease is morbid condition of young productive population, that could impair quality of life with high cost for health care system. No consensus exists on optimal surgical treatment, even if several techniques have been proposed. In this preliminary experimental case-control study the investigators compared excision by knife and diathermy with the aim to investigate if wound dehiscence could be related to heat spreading during excision of the sinus.

Full description

Between January 2017 and February 2018, 29 patients underwent to sinus excision. The investigators considered 16 sinus excision performed by diathermy as a case group (named "Hot" group) and the last 13 procedures performed by knife as control group (named "Cold" group). Temperature data were recorded for both group. Follow-up was carried out until complete healing. Were considered primary and secondary outcomes.

Enrollment: 29 patients

Sex: All

Ages: 14 to 52 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male and female patients between 14 and 65 years old,
• primary, non recurrent pilonidal disease
• midline and intergluteal location
• spinal anesthesia
• dimension no more than 5 cm in length, primary closure performed

Exclusion criteria

• age < 14 and > 65 years old,
• secondary fistulous tracts or lateral developing/cutaneous opening
• dimension over 5 cm in length,
• local anesthesia employ
• smoker and obese patients (BMI> 25 kg/m2)
• diabetic and coagulopathies affected one
• flogged or acute or infected or abscessed forms
• ASA score > IV,
• normal range WBC and Hb preoperative values.

Trial design

29 participants in 2 patient groups

16 patients, named "Hot" group

Description:

We considered 16 sinus excision by diathermy as a case group (named "Hot" group)

Treatment:

Procedure: in "Cold" group 13 patients were treated by scalpel.

Procedure: In "hot" group 16 patients were treated by diathermy in "Cold"

13 patients, named "Cold group"

Description:

13 procedures performed by knife as control group (named "Cold" group).

Treatment:

Procedure: in "Cold" group 13 patients were treated by scalpel.

Procedure: In "hot" group 16 patients were treated by diathermy in "Cold"