A prospective single-blinded randomized multi-center clinical trial comparing the clinical efficacy and patient acceptability of open selective haemorrhoidopexy with stapled haemorrhoidopexy

Until today, it seems there is no optimal treatment for 3rd, 4th degree and
recurrent haemorrhoidal disease. All available treatment modalities have
important disadvantages, ranging from significant postoperative pain to high
recurrence rates.
Stapled haemorrhoidopexy is a widespread used procedure in case of 3rd degree,
selected cases of 4th degree haemorrhoidal disease and in case of recurrence.
With this procedure a circular partial resection of the mucosa proximal from
the haemorrhoidal tissue is performed. Postoperative pain is significantly less
compared to the traditional haemorrhoidectomy. In open haemorrhoidectomy the
haemorrhoidal tissue itself is excised, resulting in relatively large wounds in
the sensitive perianal area. Another advantage of the stapled haemorrhoidopexy
compared with the open haemorrhoidectomy is that the haemorrhoidal tissue is
preserved with the stapler technique. Maintenance of haemorrhoidal tissue is
important to maintain optimal rectal sensitivity anal continence. However, the
stapled haemorrhoidopexy has disadvantages like high costs and - although very
rare - has been associated with complications like pelvic abcesses and
fistula*s. Therefore, adequate training is mandatory before performing stapled
haemorrhoidopexy..
In 2008 Pakravan presented a new technique describing selective
haemorrhoidopexy with only sutures. The technique consists of a selective pexy
of prolapsing haemorrhoidal tissue without resection of circular flap of
mucosa. From this point of view it is very similar to the above mentioned
stapled haemorrhoidopexy, with preserving the haemorrhoidal tissue. A
considerable advantage of the selective haemorrhoidopexy are the low costs as
no special stapling devices are needed for this procedure and the short
learning curve. Early results of Pakravan*s technique show good results in
regard to postoperative pain, recurrence and continence. Long term results are
not available until now.

The purpose of this prospective randomised trial is 1) to compare short- and
long-term efficacy of open selective haemorrhoidopexy with stapled
haemorrhoidopexy; 2) to compare patients satisfaction between open and stapled
haemorrhoidopexy.

The study has a randomized, controlled, single blind, clinical multicenter
trial study design.
The study will be conducted by the Department of Surgery of the University
Hospital Maastricht in co-operation with selected hospitals in the Netherlands
and Germany (Laurentius Hospital Roermond, Atrium Medisch Centrum Heerlen,
Máxima Medisch Centrum Veldhoven, Diaconessenhuis Leiden, Helder Kliniek
Eindhoven, Coloproktologisches Zentrum Düsseldorf). All consecutive patients
visiting the outpatient clinic with complaints of haemorrhoidal disease 2nd to
4th grade (after 2 treatments of Barron ligations) will be considered for the
study. All patients have had proctoscopy to determine the grade of
haemorrhoidal disease. Furthermore, all patients of over 40 years old have had
colonoscopy. Goligher Classification will be used to define the grade of
haemorrhoidal disease.

If all inclusion criteria are met and no exclusion criteria are present, a
member of the Research Team will inform the patient about the purpose of the
study and review all required baseline study data of that patient candidate.
After informed consent the patient will be randomly assigned for one of the two
study groups: selective haemorrhoidopexy or stapled haemorrhoidopexy.
Randomization, data collection and data analysis will be supported by MEMIC
(Center for Data and Information Management).

The primary endpoint of the study is two years symptom free period based on
Goligher Classification. Secondary endpoints will be recorded and compared
between the two groups. The total follow-up will be two years.

It is anticipated that the total length of time required to complete the study
will be three and a half years, bases upon the following assumptions:
- 18 months to complete patient enrolments
- 2 years to complete patient follow-up.

open selective haemorrhoidopexy versus circular stapled haemorrhoidopexy

The risks associated with participation in this trial can be considered equal
to standard treatment of haemorrhoidal disease. Experience with complications
and adequate logistics are present in every clinic participating in the study.
Patients will be informed about these complications before starting treatment.