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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02222298
Other study ID # framar
Secondary ID
Status Completed
Phase N/A
First received August 19, 2014
Last updated November 2, 2015
Start date April 2012

Study information

Verified date November 2015
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority Italy: University of Naples "Federico II"
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 65 Years
Eligibility Inclusion Criteria:

- Chronic sacrococcygeal pilonidal sinus

Exclusion Criteria:

- Absence of consent to the study

- Acute abscess

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Video assisted ablation of pilonidal sinus
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.
Bascom Cleft lift procedure


Locations

Country Name City State
Italy University of Naples "Federico II" Naples

Sponsors (1)

Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Infection Wound infection was defined as redness and/or oedema of the skin and/or discharge. at 30 days after surgery Yes
Secondary recurrence recurrence was defined when symptoms of the disease recurred after an interval following complete wound healing. at 1 year after surgery Yes
Secondary return at work up to 30 days after surgery No
Secondary Pain A vas-score scale (0-10) will be used up to 30 days after surgery Yes
Secondary satisfaction a Vas-score scale (0-10) and a SF_36 model will be used up to six months after surgery Yes