Hemor-Pex System: results of the first 1 000 cases - 2f Surgical

3622 Chirurgia/Original articles
Aim. The HemorPexSystem (HPS) is a new technique for
hemorrhoid treatment consisting of the repositioning of
hemorrhoidal cushions by means of sutures determining a lifting
of anorectal mucosa, and the ligature of the branches of the
superior hemorrhoidal artery. This procedure is performed on outpatients
using a rotating dedicated anoscope (HPS). The aim of this
study was to present the results and follow-up of more than 1
000 patients operated with this technique during three years
(2003-2006).
Methods. The parameters analyzed were: postoperative pain,
incidence of complications, recurrence of affections or symptoms,
satisfaction degree. In 92% of cases the intervention was
performed under local anesthesia and 96.5% of patients was
discharged within six hours, only 3% of patients overnight.
Results. The immediate postoperative pain was absent in 5.3% of
cases, light in 59.9%, medium with tenesmus in 30.3%, intense in
4.5 %. Modest hemorrhages were reported in postoperative
between 5 and 15 days and 2% of patients had more important
hemorrhage, not requiring surgery. In 6.4% of patients a real
recurrence was present.
Conclusion. According to authors, HPS is a safe procedure, with
a short learning curve for surgeons, able to reduce postoperative
pain, applicable with local anesthesia, under ambulatory surgery,
rapid, low cost, lacking of major complications, with rapid
integration into working life.
KEY WORDS: Hemorrhoids - Hemorrhoids, therapy - Postoperative
complications.
The HermoPex Sistem (HPS) is a new technique for mucohemorrhoidopexy
conceptually similar to the Longo’s
procedure 6 and contemporarily to the transanal hemorrhoidal
dearterialization guided by Doppler. 7 This technique can be
performed with a dedicated rotating anoscope.
The proposed procedure consists in the lifting of the anorectal
mucosa and the repositioning of the hemorrhoidal cushions
in the anal canal by means of sutures which determine
a plication of the mucosa and, at the same time, the ligature
of the branches of the superior hemorrhoidal artery. This
procedure can be performed without the transection of the
Received on May 18, 2009.
Accepted for publication on June 5, 2009.
Corresponding author: C. Iachino, _Operative Unit of Day Surgery,
San Martino University Hospital, Genoa, Italy.
CHIRURGIA 2009;22:000-000
Hemor-Pex System: results of the first 1 000 cases
C. IACHINO 1, M. SACCONE 1, L. MILONE 2, G. F. GIORDANO 1, M. GIORDANO 3, F. SIAS 4
1Operative Unit of Day Surgery, San Martino University
Hospital, Genoa, Italy
2Deptartment of General Surgery, Columbia University
New York, NY, USA
3Section of Proctology, Casa di Cura Villa Igea
Acqui Terme, Alessandria, Italy
4Section of General Surgery, Chirurgia Generale
Casa di Cura Villa Santa Rita, Cagliari, Italy
mucosal ring, but modulating the removal or the cauterization
of the exuberant mucosa in the position of the six terminal
branches.
This procedure has been tested by two Surgery Operative
Units (Cagliari – Santa Rita Clinic and Genoa – San Martino
Hospital) in over 3 years of activity, with the most possible
homogeneous equipments and techniques.
Equipments and techniques
From January 2003 to June 2006, 1 112 patients were
treated by the Operative Unit of Day Surgery of San Martino
Hospital of Genoa and Villa Santa Rita Clinic of Cagliari, 719
of themwere submitted to follow-up; of them 180 presented
second degree hemorrhoids, 467 third degree hemorrhoids and
72 at fourth degree hemorrhoids; 456 patients were male
and 263 were female with an average age of 47 years (range
20-87).
After an accurate clinical examination the majority of the
patients were submitted to a colonoscopy. Only 19 patients
refused colonoscopy and underwent a radiography with a
clysma.
This kind of operation has been decided after a preliminary
interview with the patient, during which surgeon has explained
the technique, the kind of anesthesia, the advantages in comparison
with the standard procedures, the time of hospital
stay and the presumed time of recovery.
The exclusion criteria have been compared to the eligibility
in Day Surgery. All the patients have been submitted to
anesthesiologic assessment.
VOL. 22 - N. CHIRURGIA 1

IACHINO HPS: RESULTS OF THE FIRST 1 000 CASES
All the patients have been provided with some anesthetic
cream (Emla) applied in the anal region two hours before
the operation.
The operations have been performed in 92% of cases under
sphincterial local anesthesia (carbocaine 2% 15cc) and in
7% of cases no anesthesia has been used. Only 9 patients
asked for general anaesthesia (4 cases) or spinal anesthesia
(5 cases).
Midazolam has been administered to all the patients in
variable quantity from 5 to 10 mg i.v.
The patients have been operated prevalently in prone position
(Jack-Knife) or left lateral (Sims); only in very few cases
the patients have been treated with general anesthesia or
under explicit request of the patient, patients have been operated
in gynecological position.
The effective average duration of the surgical operation was
about 20 minutes (range 15-25).
The outpatient checks and follow-ups were fixed at 7-30-
60 days and at one year from surgery to check any inconvenience,
complication and recurrence.
In a total of 1 112 patients, 719 (N) have been checked for
follow-up.
After the procedure, the patients were asked to describe the
entity of pain with a Visual Analogue Scale (VAS) from 0
(absence of pain) to 10 (very painful).
A single use device made by a fixed part has been used for
the operation, by a rotating operative part which includes a
window through which the suture stitches are posed, named
HPS.
The proposed procedure consisted in repositioning of
the hemorrhoidal cushions in their anatomical place by
means of anorectal sutures determining a plication of the
mucosa over the combed line and, in the long term, the formation
of a scar anchoring the mucosa to the underlying
musculature. These sutures are represented by Z stitches
(single or multiple); they are posed at the level of the
hemorrhoidal pedicles (right anterior, right posterior and
left lateral) and in the intermediate positions, in order to
obtain a major support and to close the branches of the
superior haemorrhoidal artery like in the Hal-Doppler
technique. 7
The suture stitches were 6 Z stitches corresponding to the
hours 1-3-5-7-9-11 proximal to the combed line, modulating
the distance between the passages of the needle on the basis
of the prolapse entity. Suture needle 21mm half-circle with
slow absorbable suture (Vycril 2/0 or 3/0) or non-absorbable
suture (Polypropylene 2/0 or 3/0).
Results
All the operations were performed with the described procedure;
96.5% patients (694) were discharged within 6 hours
from the operation (Day Surgery); 3.5% (14) were treated with
One Day Surgery, and no patient was sent to ordinary hospitalization.
All cases were treated with intravenous antibiotic therapy
and in the majority of the patients a home therapy with
metronidazole has been prescribed. At the time of discharge
non stupefacient analgesics by oral way was prescribed.
The first defecation after the operation came spontaneously
about 24 hours later (82% of cases). The remaining
patients were treated with saline purgatives on the III postoperative
day. The resumption of the working activity was 3
days after the surgery (range 1-7 days).
In all the cases, independently from the administration
of pain-killers, was reached a suitable level of analgesia
registering a VAS average of 3 with a good compliance
from the patients (average general pleasure of
3.3). Immediate postoperating hemorrhages were never
recorded. In 32 patients an acute retention of urine
occurred (4.5%); 139 cases (19.3%) complained a discreet
or notable anal or perianal edema. The postoperative
immediate pain was intense in 32 cases (4.5%) (VAS 7-
10); medium with tenesmus in 218 cases (30.3%); light
(VAS 1-3) in 431 cases (59.9%); absent (VAS 0) in 38 cases
(5.3%).
The long term results were the followings: in the ambulatory
check-up after 30 days the major part of the patients
(64%) reported modest rectal haemorrhage between the V
and the XV day. We have recorded persistence of tenesmus
in 114 cases (15.9%); 3 cases of pararectal fistula (0.4%);
218 cases of feeling of endorectal puncture (30.3%); 26
cases of perianal bruising (9.5%); 6 cases of pararectal
abscess (0.8%).
During the third ambulatory check-up (60 days later) we
have recorded 3 cases of perianal fistula (0.4%); 2
pseudopolyps (0.3%); 3 cases of hematospermy (0,4%); 2
cases of fecal incontinence (0.2%), resolved in less then
three months; 13 cases of gas incontinence (1.8%) resolved
in less then three months; in 46 cases a real recurrence was
present (6.4%) and in 158 patients it has been noticed a persistence
of skin tags (22.0%).
Conclusions
The results of our experience show that the surgical
treatment of haemorrhoidal pathology with the HPS, in
presence of prolapse of various degree, can be easily performed
in Day Surgery regime. The percentage of perioperatory
bleedings recorded (0%) is inferior to any published
in literature, 7 that is comprised between 0.5% and 4%
of risk of late postoperative hemorrhage. This fact is to put
in relationship with the extreme easiness to suture the blood
vessels under vision through the application of the Z stitches.
The 14 cases in which it was necessary a “one day” admission
to hospital, were not depending from the surgical operation,
but from the immediate complications (intense pain;
acute retention of urine in patients residents at more than
150 km of distance from the hospital).
On the basis of our experience we believe that the postoperative
pain could depend not only from the type or
technique but also from particular tricks. In this case it
finds importance the postoperative assumption of
Metronidazole, which by now we almost use routinely
both for medical legal reasons and for its postoperative
pain reduction effect. 8
We are used to precociously use antiedemigenic and cortisonic
drugs in patients that presents edema, bruising or
2 CHIRURGIA MESE, 2009

HPS: RESULTS OF THE FIRST 1 000 CASES IACHINO
hematomas, complications heralding pain and annoying
tenesmus.
We have ascertained that in 218 cases where a feeling of
endorectal puncture with tenesmus persisted, it was due to the
use of prolene suture.
The endoscopic removal of stitches even at one year distance
has in fact definitely resolved such problem, that stopped
to occur from when we have decided to use absorbable suture
stitches (Vycril).
In the two cases named as “pseudopolyps” it has been
performed a polypectomy during an endoscopic check-up,
considering that we thought that they were real polyps.
On the contrary, the histological examination induced us
to think that they were mucous exuberances similar to polyps
determined from the mucopexy stitches.
The cases of hematospermy have surely been caused by
errors of technique and they make us think about how much
dangerous can be the apposition of deep stitches in correspondence
of the anterior rectal hemicircle, with possible
serious results (rectovaginal fistulas and so on) similar as
what has been reported with Longo’s technique. 9
On the other hand we have not to underestimate the
pararectal and perianal abscessual complications, ending in
fistulas that needed further surgical treatment.
These complications primarily occurred in diabetic or cardiopathic
patients under anticoagulant therapy and/or obese
patients.
Such pathologies have determined the greatest number of
recurrences.
Relatively at these last, at a first distance control, the percentage
seemed extremely high.
Subsequently, taking back well in consideration the objective
examination before the operation, we have been able to
verify that the majority of patients (22%) that seem to have
recurrences, had in reality persistence of skin tags, that once
we used to leave in place, but lately we have begun to remove
on express patient request, warning him of the possible onset
of postoperative pain, due to the removal of cicatricial tissue
extroversions.
The true recurrences (6.4%) until here observed seem to
be perfectly in line whit the ones reported with the techniques
currently used for the treatment of haemorrhoidal
prolapse.
We didn’t find explanations in cases of fecal incontinence
2 and metoerism 13 that spontaneously resolved in about 2-3
months time: we believe however that they could be partly preexisting
before the surgical intervention.
In conclusion, in our opinion the HPS technique has numerous
advantages: it is a safe, easy to learn technique that offers
a noticeable reduction of postoperative pain, applicable simply
with sphincterial local anaesthesia or even with mild
sedation, rapid, repeatable, low cost, lacking of major complications
and with few minor complications. Excellent
patient compliance with consequent rapid resumption of the
working activity.
Riassunto
Hemor-pex system: risultati dei primi 1 000 casi
Obiettivo. L’HemorPexSystem (HPS) è una nuova tecnica di
mucoemorroidopessia che consiste nel riposizionamento delle colonne
emorroidarie nella loro sede, e contemporaneamente nella dearterializzazione
dei rami dell’arteria emorroidaria superiore.
L’intervento viene praticato tramite un anoscopio rotante dedicato
con sei suture a Z eseguite sotto visione attraverso la finestra dello strumento.
Sono stati analizzati i risultati ottenuti e il follow up su oltre
1 000 pazienti sottoposti a tale procedimento tra il 2003 e il 2006.
Metodi. I parametri valutati sono stati i seguenti: dolore postoperatorio,
incidenza di complicanze e sintomatologia, recidive, grado di
soddisfazione.
Risultati. In oltre il 90% dei casi l’intervento venne eseguito in
anestesia locale e la dimissione avvenne entro sei ore (Day Surgery).
Soltanto nel 3% dei pazienti fu necessario il pernottamento (One Day
Surgery). Nel 5,3% dei casi si registrò assenza di dolore, nel 59,9%
dolore lieve, nel 30,3% medio con tenesmo, nel 4,5% intenso. Modeste
proctorragie si verificarono nell’immediato postoperatorio, mentre nel
2% si rilevarono emorragie più importanti che non richiesero comunque
trattamento chirurgico. Le recidive reali riscontrate sono il 6,4%.
Conclusioni. Riteniamo che l’HPS sia un procedimento sicuro,
di facile apprendimento, in grado di ridurre notevolmente il dolore
postoperatorio, eseguibile in anestesia locale, rapido, scevro di complicanze
maggiori, che consente una rapida ripresa lavorativa.
PAROLE CHIAVE: Emorroidi - Emorroidi, trattamento - Complicazioni
postoperatorie.
References
1. Dennison AR, Paraskevopoulos A, Kerrigan DD, Shorthouse AJ.
New thoughts on the aetiology of haemorrhoids and the development
of nonoperative methods for their management. Int Surg Sci
1995;2:31-5.
2. Goligher C. Surgery of the anus, rectum and colon. London: Ed.
Bailliere Tindall ;1980. p. 4.
3. Gaj F, Trecca A, Buzzi N, Restifo A, Tonelli F. Il censimento di centri
nazionali di colonproctologia: il profilo e le principali problematiche
dellacolonproctologia nel nostro paese. Coloproct 2000;19:3.
4. Milligan ETC, Morgan CN, ]ones LE, Officer R. Surgical anatomy
of the anal canal and operative treatment of haemorrhoids. Lancet
1937;2:1119-24.
5. Ferguson EF. Alternatives in the treatment of hemorroidal disease.
South Med J 1988;81:606-10.
6. Longo A. Treatment of haemorrhoids disease by reduction of mucosa
and haemorrhoidal prolapse with a circular suturing deivice: a
new procedure. Proceedings of the 6th world congress of endoscopic
surgery. Rome, Italy, June 3-6 1998.
7. Milson JW. Hemorrgoidal disease. Wexner SD, Beck DE, eds. Fundamentals
of Anorectal Surgery. New York: McGraw Hill;1992. p.
192-214.
8. Milito G, Cortese F, Brancaleone C, Casciani CD. The role of prophylactic
metronidazole in the management of postoperative pain after
haemorrhoidectomy. Tech Coloproctol 1996;4:84-6.
9. Palazzo FF, Francis DL, Clifton MA. Randomized clinical trial of
Ligasure versus open haemorrhoidectomy. Br J S 2002;89:154-7.
10. Milito G, Gargiani M, Cortese F. Randomized trial comparing Ligasure
haemorrhoidectomy with the diathermy dissection operation.
Tech Coloproctol2002;6:171-5.
11. FrankIin EJ, Seetharan S, Lowney J, Horgan PG. Randomized, clinical
trial of Ligasure vs. conventional diathermy in hemorrhoidectomy.
Dis Colon Rectum 2003;46:1380-3.
VOL. 22 - N. CHIRURGIA 3