Pilonidal Sinus Disease: Preliminare Study

Completed

• Conditions: Pilonidal Sinus
• Interventions: Procedure: In "hot" group 16 patients were treated by diathermy in "Cold"; Procedure: in "Cold" group 13 patients were treated by scalpel.

• Registration Number: NCT03764657
• Lead Sponsor: Ospedale di Cavalese

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2018-11
• Study First Submitted: 2018-11-25
• Study First Submitted QC: 2018-12-04
• Last Update Submitted: 2018-12-04
• Study First Posted: 2018-12-05
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
13 patients, named "Cold group"	In "hot" group 16 patients were treated by diathermy in "Cold"	13 procedures performed by knife as control group (named "Cold" group).
16 patients, named "Hot" group	In "hot" group 16 patients were treated by diathermy in "Cold"	We considered 16 sinus excision by diathermy as a case group (named "Hot" group)
16 patients, named "Hot" group	in "Cold" group 13 patients were treated by scalpel.	We considered 16 sinus excision by diathermy as a case group (named "Hot" group)
13 patients, named "Cold group"	in "Cold" group 13 patients were treated by scalpel.	13 procedures performed by knife as control group (named "Cold" group).

Primary Outcome Measures

Name	Time	Method
Number of complete wound healed and not healed after 8 postoperative days	Up to 4 weeks	We established as primary outcomes, the number of wound completely healed after 8-12 days

Secondary Outcome Measures

Name	Time	Method
types of complications (Dindo-Clavien)	follow-up 12 months	the type of complication was divided into 2 types, Grade I and II
post-operative pain in first postoperative day (analogue pain score, VAS)	7 days	postoperative pain was recorded in the two groups using the analog pain scale (VAS, range 0-10, the lowest value indicates less pain and the highest value indicates)
operative time for complete excision of the sinus (minutes)	minutes (range 0-30 minutes)	the operative time for complete excision was compared into the two group

Trial Locations

Locations (1)

Ospedale di Cavalese; 🇮🇹 Cavalese, Trento, Italy