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OpenTrials
Completed

NCT Number: NCT02222298

Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment

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).

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Key information

Conditions

Chronic Sacrococcygeal Pilonidal Sinus

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Naples "Federico II"

Naples, Italy, 80131

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic sacrococcygeal pilonidal sinus

Exclusion criteria

  • Absence of consent to the study
  • Acute abscess

Treatment and study plan

Video assisted ablation of pilonidal sinus

Procedure

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

Procedure

Primary outcomes

  1. Infection

    Time frame: at 30 days after surgery

    Wound infection was defined as redness and/or oedema of the skin and/or discharge.

Secondary outcomes

  1. recurrence

    Time frame: at 1 year after surgery

    recurrence was defined when symptoms of the disease recurred after an interval following complete wound healing.

  2. return at work

    Time frame: up to 30 days after surgery

  3. Pain

    Time frame: up to 30 days after surgery

    A vas-score scale (0-10) will be used

  4. satisfaction

    Time frame: up to six months after surgery

    a Vas-score scale (0-10) and a SF_36 model will be used

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Video Assisted Ablation of Pilonidal Sinus Versus Convention Off-midline Bas Com Cleft Lift Procedure

Important dates

Study start
2012
Primary completion
2015
First posted
Aug 21, 2014
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.