Anal cooler for anal pain

Anal pain is a common condition. Patients with haemorrhoids, anal fissure,
peri-anal fistula, increased tone of the pelvic floor anal carcinoma or after
local surgical procedures can anal have pain. Sometimes no obvious cause can be
found. The anal pain will generally subside when the underlying cause is
treated or when the tissue has healed after the local procedure.
In patients with chronic anal pain without any obvious cause a trial with a
conservative tool is worthwhile trying. Furthermore, many local anal procedures
like rubber band ligation for haemorrhoids can be painful the first week
post-procedure
In the seventies, cryotherapy as a method of home treatment was used in various
conditions, especially haemorrhoids with favourable results. A special device
was developed, a cylindrical shaped plastic device containing a mixture of
glycols, which can be frozen in the freezer. Experimental studies in dogs have
demonstrated a fall of 10o in rectal mucosal temperature.
Favourable reports have been published as well as oral communications, however
no controlled study was performed. Recently, a private company revived this
device. In order to objectivate the clinical effects from this device, we
wanted to conduct the following study.

to investigate the clinical effects of the Anal Cooler

Two groups of patients will be studied
I. Patients with anal pain without any obvious cause (open study)
II. Patients after rubber band ligation (randomized, control group)

Patients included in study I will ask to use the Anal Cooler and to keep a
diary for 3 weeks. Then they will return to the outpatient clinic for final
evaluation (diary, VAS, QOL, physical examination).
Patients included in study II will be randomized by a printed list. Patients
will receive the Anal Cooler or nothing (placebo). After the rubber band
ligation, these patients will ask to keep a diary as welll. After 3 weeks, the
patients will return to the outpatient*s clinic for final evaluation. The diary
will be discussed and patients will be asked to fill in a questionnaire.

The anal cooler needs to be stored in a deep-freeze (-18 oC) for 3 hours. The
cooler will be introduced into the anus while the patient sits or lies on his
side. After 10-20 minutes the cooler will be withdrawn, cleaned in a proper
domestic manner (soap and warm water, dried with a towel) and restored in the
deep freezer in a plastic bag.

No specific ethical problems exist. No side effects besides local cooling can
be expected.