Sinus pilonidalis (haarnestcyste in de bilspleet): fenolisatie (dichtbranden) vs. radical excisie (operatieve behandeling); een gerandomiseerde studie

Pit Excision with Phenolisation of the Sinus Tract vs. Radical Excision in Sacrococcygeal Pilonidal Sinus Disease; A Randomised Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29335

Enrollment

100

Registered

2013-06-24

Start date

2013-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sacrococcygeal Pilonidal Sinus Disease Haarnestcyste Sinus pilonidalis

Interventions

Intervention: Pit excision of the sacrococcygeal pilonidal sinus disease, debridement of the sinus tract followed by phenolisation of the sinus tract under local anesthesia in an ambulatory setting.

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patient with symptoms due to chronic Sacrococcygeal Pilonidal Sinus Disease interfering with life (non-silent Sacrococcygeal Pilonidal Sinus Disease); 2) Age ≥ 18 years; 3) Written informed consent is obtained.

Exclusion criteria

Exclusion criteria: 1) No or minimal symptoms related to Sacrococcygeal Pilonidal Sinus Disease; 2) Suspicion of extensive subcutaneous network of sinus tracts, especially in the case of more than three off-midline orifice, as these sinuses are not eligible for phenolisation treatment; 3) Abscess of Sacrococcygeal Pilonidal Sinus Disease; 4) Previous surgical procedures for Sacrococcygeal Pilonidal Sinus Disease.

Design outcomes

Primary

Measure	Time frame
Loss of days of normal activities/ working days (measured from the start of the treatment).	—

Secondary

Measure	Time frame
1) Anatomic recurrence rate; 2) Symptomatic recurrence rate (Visick satisfaction rate); 3) Quality of Life (obtained by the Short Form-36 (SF-36) and visual analogue scale); 4) Surgical site infection (cellulitis vs. abscess, treatment must be necessary to report a surgical site infection, i.e. antibiotics or opening of the wound) scored by the Southampton wound scoring system; 5) Time-to-wound-closure (complete epithelisation); 6) Symptoms related to treatment (fluid, pain, irritation, itch, burning); 7) Pain (daily scored by a visual analogue scale during the first two weeks after each operation; daily mean score after treatment and total days of pain determined); 8) Usage of pain medication; 9) Total treatment time (from start of treatment to cure of the Sacrococcygeal Pilonidal Sinus Disease); 10) Sexual function (Sexual Self-Consciousness Scale, SSCS).	—

Measure

Time frame

1) Anatomic recurrence rate; 2) Symptomatic recurrence rate (Visick satisfaction rate); 3) Quality of Life (obtained by the Short Form-36 (SF-36) and visual analogue scale); 4) Surgical site infection (cellulitis vs. abscess, treatment must be necessary to report a surgical site infection, i.e. antibiotics or opening of the wound) scored by the Southampton wound scoring system; 5) Time-to-wound-closure (complete epithelisation); 6) Symptoms related to treatment (fluid, pain, irritation, itch, burning); 7) Pain (daily scored by a visual analogue scale during the first two weeks after each operation; daily mean score after treatment and total days of pain determined); 8) Usage of pain medication; 9) Total treatment time (from start of treatment to cure of the Sacrococcygeal Pilonidal Sinus Disease); 10) Sexual function (Sexual Self-Consciousness Scale, SSCS).

—

Contacts

Public ContactE.J.B. Furnée

AIOS Chirurgie Diakonessenhuis Utrecht Bosboomstraat 1 Postbus 80250

efurnee@diakhuis.nl088 – 250 6615

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)