|- candidate number||15033|
|- NTR Number||NTR4043|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-jun-2013|
|- Secondary IDs||ABR-43192 METC: Verenigde Commissies Mensgebonden Onderzoek (VCMO)|
|- Public Title||Sinus pilonidalis (haarnestcyste in de bilspleet): fenolisatie (dichtbranden) vs. radical excisie (operatieve behandeling); een gerandomiseerde studie|
|- Scientific Title||Pit Excision with Phenolisation of the Sinus Tract vs. Radical Excision in Sacrococcygeal Pilonidal Sinus Disease;
A Randomised Controlled Trial
|- hypothesis||The hypothesis of this study is that phenolisation of the sinus tract vs. primary surgical excision in patients with a symptomatic sacrococcygeal pilonidal sinus disease reduces days unable to do normal activities with only a small increase in recurrence rate.|
|- Healt Condition(s) or Problem(s) studied||Pilonidal cyst, Sinus pilonidalis, Sacrococcygeal Pilonidal Sinus Disease|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2013|
|- planned closingdate||1-sep-2014|
|- Target number of participants||100|
|- 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.
Comparison: Radical surgical excision of the sinus tract and primary closure of the wound under spinal or general anesthesia in an one-day surgery setting.
|- Primary outcome||Loss of days of normal activities/ working days (measured from the start of the treatment).|
|- Secondary outcome||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).
|- Timepoints||1) diary for the first two weeks after surgical excision or after each phenolisation procedure;|
2) postoperative questionnaire for patients (obtained after 2, 6, 12, 26 and 52 weeks);
3) postoperative assessment form for the physician (obtained after 1-6, 12, 26 and 52 weeks).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. E.J.B. Furnée|
|- CONTACT for SCIENTIFIC QUERIES||Dr. E.J.B. Furnée|
|- Sponsor/Initiator ||Diakonessenhuis Utrecht, The Netherlands.|
(Source(s) of Monetary or Material Support)
|Diakonessenhuis Utrecht, The Netherlands.|
|- Brief summary||Background/ rationale: |
Sacrococcygeal pilonidal sinus disease (SPSD) is an acquired disorder of the natal cleft. Excision of the pit of the sinus with phenolisation of the sinus tract and surgical excision are two treatment modalities for SPSD. Phenolisation seems to have advantages over local sinus excision as it is performed under local anaesthesia with a relatively small surgical procedure, less postoperative pain, minor risk of surgical site infection (8.7%) and only a few days unable to do normal activity (mean of 2.3 days). The disadvantage may be that phenolisation has to be repeated a second time in some patients and the some higher risk of recurrence (13%). Surgical excision of SPSD has a recurrence rate of 11%. The disadvantages, however, are the postoperative pain and the high risk of surgical site infection and the hereby large amount of days with loss of normal activities (mean of about 10 days). So, the recurrence risk based on the current non-randomised studies is some higher for the phenolisation treatment but the number of days unable to do normal activities is highly favourable, probably due to less pain and less risk of surgical site infections.
The objective of this study is to show that excision of the pit of the sinus of SPSD with phenolisation of the sinus tract is accompanied with sooner return to normal daily activities compared to local excision of the sinus with only a small increase in recurrence rate.
Randomised controlled trial.
All patients who present in the out-patient clinic of the participating centre in the Netherlands with SPSD.
Excision of the pit of the sinus followed by phenol applications of the sinus tract compared to radical surgical excision of the sinus.
Primary endpoint: loss of days of normal activities/ working days.
|- Main changes (audit trail)|
|- RECORD||24-jun-2013 - 8-jul-2013|