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

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 frequently used 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 may be repeated a second time and the 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 of recurrence rate.

Randomised controlled trial.

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

The risks are low for both treatment modalities as the safety of both has
already been established. Excision of the pit of the sinus with phenolisation
of the sinus tract seems to have advantages as it is performed under local
anaesthesia, gives less postoperative pain, low risk of surgical site infection
and only a few days unable to do normal activities. The disadvantage may be the
some higher risk of recurrence. However, it seems unlikely that this treatment
does compromise or negatively influence surgical excision if necessary in the
future. Surgical excision of SPSD is currently the most frequently used
treatment for symptomatic chronic SPSD. The disadvantage of this treatment are
the postoperative pain, high risk of surgical site infection and the large
amount of days with loss of normal activities. The burden of this study is low
for the participating patients as we only ask the patients to answer some
questions by a questionnaire preoperatively and at some points after the
operation. The number and time of out-clinic visits are not different compared
to the normal treatment of SPSD.