The main objective of this study is to establish the efficacy of *pit picking with laser therapy* versus *pit picking alone* on both short and long-term outcomes.
ID
Source
Brief title
Condition
- Anal and rectal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: The overall success rate of treatment which is defined as:
closure of all pits, and the absence of symptoms, persisting sinuses or
recurrence of pilonidal disease within 12 months.
Secondary outcome
Secondary endpoints: wound closure time, patient experience, pain,
complications, work rehabilitation, time to return to daily activities, quality
of life, costs and the need for secondary or revision surgery.
Time points of measurement are defined as: T = 0 (baseline), 2 weeks, 4 weeks,
6 weeks, 6 months, 1, 3 and 5 year after treatment.
Background summary
Pilonidal sinus disease (PSD) is a burdening disease with a prevalence of
26/100.000 individuals, mostly affecting young men. Conventional treatment of
pilonidal disease consists of a wide array of excisional surgery techniques,
often requiring multiple operations, which lead to high morbidity and
significant medical costs. Pit picking is a simple minimally invasive approach
that can be performed in an outpatient clinic setting with local anaesthesia,
potentially lower costs and higher overall patient satisfaction. However,
higher recurrence rates have been reported. Adjuvant laser therapy might
provide a valuable option to decrease recurrence rates and improve wound
healing time, but the benefit of the laser has to be established yet.
Study objective
The main objective of this study is to establish the efficacy of *pit picking
with laser therapy* versus *pit picking alone* on both short and long-term
outcomes.
Study design
The study concerns a multicentre, single-blinded, randomised, controlled,
superiority trial. It will investigate the additional value of laser therapy
regarding the success rate of treatment. Patients will be accrued by all
participating centres. The design involves allocation of all appropriate
consecutive patients with primary pilonidal sinus disease to pit picking alone
or combined with laser therapy. Data will be analysed on *intention to treat*
and *treated as* basis.
Intervention
Pit picking surgery alone or combined with laser therapy. Both interventions
are considered standard of care in the participating centres.
Study burden and risks
The extra burden for participating patients is expected to be minimal to
moderate. Patients will have two extra hospital visits in case they are
enrolled in our study: 6 and 12 months after enrolment. Postoperatively the
normal scheme of follow up appointments will be used: 2 and 6 weeks after
treatment at the outpatient clinic of the treating surgeon. A telephone
appointment with the researcher will be scheduled 4 weeks after treatment.
Patients are asked to complete questionnaires at various time points, which
will be sent to them by email and will take approximately 5-10 minutes each
time. The content includes general and disease specific Quality of Life (QoL)
questionnaires. We do not expect any extra adverse reactions or events in
respect to participation in the study because both procedures are considered
standard of care in the participating clinics. However, because both
interventions are surgical procedures a small percentage of adverse events or
postoperative complications can be expected.
Albert Schweitzerplaats 25
Dordrecht 3318AT
NL
Albert Schweitzerplaats 25
Dordrecht 3318AT
NL
Listed location countries
Age
Inclusion criteria
• All patients aged 12 years and older who present with primary pilonidal sinus
disease; Type 1b and 3 of the Dutch staging system
• Obtained written informed consent by the patient and/or legal
representative/parent
• Sufficient understanding of the Dutch written language (reading and writing)
• Eligible for questionnaires sent by e-mail
Exclusion criteria
• Asymptomatic (Type 1a), recurrent (Type 4; except those patients who only
have had drainage of their abscess and no other surgical treatment), or chronic
wounds (hypergranulating) after PSD surgery (Type 5) of the Dutch staging
system.
• Patients with known underlying or concomitant medical conditions that may
interfere with normal wound healing (e.g. systemic skin and connective tissue
diseases, any kind of congenital defect of metabolism including
insulin-dependent diabetes mellitus, Cushing syndrome or disease, scurvy,
chronic hypothyroidism, congenital or acquired immunosuppressive condition,
chronic renal failure, or chronic hepatic dysfunction (Child-Pugh class B or
C), severe malnutrition, or other concomitant illness which, in the opinion of
the investigator, has the potential to significantly delay wound healing)
• Severe drug abuse (and therefore protocol deviation can be expected)
• Patients expected not to comply with the study protocol (including patients
with severe cognitive dysfunction/impairment and severe psychiatric disorders)
• Patients with insufficient knowledge of the Dutch written language who are
thus unable to answer the questionnaires
• Patients that are unable or not willing to give full informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06140199 |
| CCMO | NL84679.018.23 |