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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41550

Enrollment

100

Registered

2013-06-18

Start date

2013-09-20

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

nest of hairs Pilonidal sinus disease

Interventions

Excision of the pit of the sinus followed by phenol applications of the sinus tract compared to radical surgical excision of the sinus.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Patient with symptoms due to chronic SPSD interfering with life 2) Age >= 18 years 3) Written informed consent is obtained

Exclusion criteria

Exclusion criteria: 1) No or minimal symptoms related to SPSD 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 SPSD 4) Previous surgical procedures for SPSD

Design outcomes

Primary

Measure	Time frame
Loss of days of normal activities/ working days.	—

Secondary

Measure	Time frame
Anatomic recurrence rate, symptomatic recurrence rate, quality of life, surgical site infection, time-to-wound-closure, symptoms related to treatment, pain, usage of pain medication, total treatment time.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)