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

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.

Objective:

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.

Study design:

Randomised controlled trial.

Study population:

All patients who present in the out-patient clinic of the participating centre in the Netherlands with SPSD.

Intervention:

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.

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.

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).

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.