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PPH en USA. 15th Annual Colorectal Disease Symposium, Cleveland Clinic Florida-13/02/2004

PPH: The U.S. Experience
Steven D. Wexner M.D., FACS, FRCRS, FRCS (Ed)
Chief of Staff
Chairman, Department of Colorectal Surgery
Cleveland Clinic Florida, Weston, FL
Professor of Surgery, Ohio State University Health Sciences Center
at the Cleveland Clinic Foundation
Clinical Professor, Department of Surgery, University of
South Florida College of Medicine
Giovanna M da Silva, MD
Cleveland Clinic Florida

Introduction
Hemorrhoids consist of cushions of submucosal tissue composed of blood vessels,
smooth muscle fibers and supporting connective tissue, normally present in the anal canal
of every human being. The term “hemorrhoids” however is also applied in situations
when these cushions become symptomatic, causing bleeding, prolapse and less
commonly, pain.
Currently, it is estimated that 10 million people in the United States are affected by
hemorrhoids, corresponding to a prevalence rate of 4.4%. One-third of these patients
present for medical advice and 316,000 are hospitalized (1). Additionally, an average of
1.5 million prescriptions is for hemorrhoidal preparations.
The pathogenesis of hemorrhoids is unclear, although many theories have been postulated
over the years. The theory that hemorrhoids are varicose veins secondary to the upright
position is no longer accepted due to the demonstration that venous dilation is present in
infants. It has also been shown that hemorrhoids are not more prevalent in patients with
portal hypertension than in the normal population (2). Finally, bleeding from
hemorrhoids seems to arise from arterioles rather than venules. The assumption that
hemorrhoids originate with hyperplasia and hypertrophy of the anal cushions has also
been disproved by the lack of histological difference in the vascular anatomy between
normal and pathologic hemorrhoidal tissue (3). The most currently accepted theory is that
hemorrhoids occur due to downward slippage of the anal cushions and anal mucosa due
to fragmentation of the supporting tissues (Treitz’ and Park’s ligaments), which can occur
secondary to stretching or constitutionally lax connective tissue (3). The prolapse would
then hinder the venous flow leading to dilation of the anal cushions in turn exposing them
to vascular complications such as edema, congestion, thrombosis and bleeding.
Hemorrhoids can be classified in external and internal with further subclassification of
the internal group into first-degree (bleeding without prolapse) second-degree (prolapse
out of the anus with spontaneous reduction) third-degree (prolapse requiring manual
reduction) and fourth –degree (incarcerated prolapse). The many treatment options for
hemorrhoids are used according to the severity of the symptoms. While conservative
measures are efficient to resolve less symptomatic disease, surgery remains the best
option for patients with more severe hemorrhoids (grade III or IV). Surgical treatment
may also be indicated for patients who fail medical management and individuals with
concomitant anorectal disease. However, intense postoperative pain is the major
drawback of surgical therapy and the main reason for patients’ resistance to treatment.
Urinary retention and constipation are other frequent sequelae of standard
hemorrhoidectomy which may be at least in part secondary to postoperative pain.
In 1998, Longo introduced the Procedure for Prolapse and Hemorrhoids (PPH) or stapled
anopexy, which is a different concept in the treatment of the hemorrhoids (4). Instead of
surgically excising the hemorrhoids, this minimally invasive technique restores the
affected anal cushions to their correct anatomic position. A circumferential strip of the
mucosa in the distal rectal ampulla is excised, interrupting the vascular supply to the
cushions while anchoring them in their proper anatomical site within the anal canal. As a
result, there is an improvement in venous return, which helps to prevent bleeding, and
reduce friction between stool and the anal mucosa during evacuation.
In general, PPH has been used for grade III or IV hemorrhoids. However, some authors
also include symptomatic grade II hemorrhoids unresponsive to other treatment. PPH
may also have a role in the emergency setting in the treatment of thrombosed
hemorrhoids (5). Contraindications are rare but may include fistula and abscess which
could lead to severe septic complications, polyps requiring histological examination and
patients with impaired sphincters, who could sustain further injury (6).
Results outside the U.S
Table 1 summarizes the results of some randomized controlled trials outside the U.S.
Overall, the main advantage of the technique over the traditional approach is reduced
postoperative pain. Other advantages include shorter hospital stay and earlier ability to
return to work.
The two most common early postoperative complications are bleeding and urinary
retention, which may occur from 3.2 to 8.8% and from 1.5 to 15% of the cases,
respectively (7,8,9). Severe postoperative pain may occur and become persistent in up to
31% of the patients (10). This pain may be attributed to insufficient distance of the suture
line from the dentate line (< 2cm). Correa-Ravelo et al (11) found a significant
correlation between the intensity of the pain and the presence of squamous epithelium in
the histological analysis of the specimen.
Just recently, Carriero and Longo (12) published their entire experience from 1993 to
2002, which represents the largest series to date. The authors assessed the short- and
long-term results with PPH in terms of patient satisfaction, length of hospital stay, time
needed to return to work and to normal social activities, postoperative pain and incidence
of early and late complications. A total of 1,409 patients were included in the study. In
909 patients operated prior to October 1998, the SDH33 circular stapler (Ethicon
Endosurgery Inc, Cincinnati, OH, USA) was used, and after that, the new PPH EES
circular stapler (Ethicon Endosurgery Inc, Cincinnati, OH, USA) was adopted in 500
patients. The mean follow-up time was 13.4 (range 6-24) months, 94 (6.6%) patients had
grade II, 947 (67.2%) grade III, and 368 (26.1%) grade IV hemorrhoids.
The authors found markedly less injury to the anoderm and hemorrhoidal tissue with the
new PPH device. The mean hospital stay was 1.8 (range 1-4) days and progressively
declined after the introduction of the PPH; in the last 300 patients in the series, it never
exceeded 24 hours. Patients returned to work and to normal social activities after a mean
interval of 4.6 (range 1-32) days (7.2 days in the SDH group; 3.8 days in the PPH group).
Forty-three percent of the patients had no pain on the first postoperative day, increasing
to 61% on the second day. 566 (79%) of patients required no analgesic drugs after
discharge. Only 34 (4.7%) patients needed to take major pain killers for more than one
week following surgery. Mild analgesics were occasionally used during the first week by
116 (16.2%) patients. The presence of pain requiring analgesic was related to the distance
of the suture from the dentate line: 46% of the patients with suture line less than 2 cm
from the dentate line whereas 16% of the patients with a more distal suture line
experienced pain.
In 7.9% (57) of cases, pain occurred secondary to early postoperative complications
which included perianal edema in 19 (2.6%), external hemorrhoidal thrombosis in22
cases (3%), submucosal hematoma in 10 cases (1.4%) and perianal abscess in 6 cases
(0.8%). According to the authors, these complications seemed also to be related to the
distance of the suture line from the dentate line.
Pain at evacuation was present in 56.2% of patients prior to surgery. However, by the 2nd
postoperative day, 75.5% of the patients reported complete absence pain during and after
evacuation. This rate was slightly lower on the 8th day (68.2%), but then increased to
85.3% after one month, 93% after 6 months, 95.1% at one year, stabilizing at 95.8% at 2
years from surgery.
Preoperative bleeding was present in a total of 57.9% of the patients. Postoperatively,
Thirty (4.1%) patients had severe bleeding requiring surgical correction, while late
bleeding was observed in 1.1% of patients after one month from surgery, and in 3.6% at 2
years of follow-up. No surgery was required in any of these other cases.
Evacuatory urgency was generally present in the first days following surgery. Mild
urgency was present in 72% of cases, moderate in 18%, and severe in 10% of the
patients.
Fecal incontinence was preoperatively present in 9.9% of patients. At 2 years after
surgery, only 5 (3.6%) patients had incontinence to gas and there was no incontinence
secondary to sphincter injury. Late complications included 15 (2%) patients with
stenosis, 13 of whom achieved resolution with anal dilatation and 2 with surgical
correction.
The recurrence rate was 2.3% (5 cases) on the group treated with the SHD, requiring
operation after 5 years of follow-up, and 3.7% (5 cases) on the PPH group after 2 years of
follow-up.
The U.S. Experience
Singer et al (13) published the early results with the use of PPH for 68 patients with
hemorrhoids treated at two institutions. Patients were prospectively evaluated for
functional recovery and postoperative pain on a 1 to 10 scale. There were 45 males and
23 females with a mean age of 56 years and a median duration of symptoms of 5 years.
The mean operative time was 22.2 minutes. The operation was performed with spinal (50
%), local (40 %), or general (10 %) anesthesia and as an outpatient (56 %) or overnight
admission (44 %). Ninety-three percent of patients remained asymptomatic with a mean
follow-up of 34 weeks, whereas the remaining 7 percent required either surgical excision
or rubber band ligation for persistent symptoms. There was no mortality, new
incontinence, fecal impaction, or persistent pain. The total morbidity was 19 percent, with
urinary retention as the most common complication (12 percent). The mean pain score
decreased from 3.6 on postoperative day 1 to 1.4 at postoperative day 7. Ninety-nine
percent of patients made a complete functional recovery by postoperative day 7. The
authors concluded that PPH is safe, effective, and can be performed as an outpatient
procedure with local or regional anesthesia and is associated with minimal postoperative
pain and early recover.
The initial results of a 13 center prospective randomized controlled trial comparing PPH
with Ferguson technique were presented at the American Society of Colon and Rectal
Surgeons (ASCRS) meeting in 2002 (14). All principal investigators were trained by a
single expert and each performed 10 cases prior to study. The main parameters evaluated
included incidence of adverse events, pain level at 1, 3, 5, 7, and 14 days after surgery
and analgesic use. Patients underwent identical pre-and postoperative care and were
evaluated for 30 days after surgery. One hundred six patients were randomized and
completed surgery (57 PPH; 49 Ferguson). There were no significant differences between
the two groups for age, gender, race and preoperative quality of life as assessed by the
SF-12 questionnaire. The most common preoperative complain was bleeding, followed
by hemorrhoidal prolapse in both groups. Patients in the PPH group had more pain at
baseline than patients in the Ferguson group (not significant). Over 80% of the
procedures were performed as outpatient in both groups. The median time of surgery was
24 (0:11-1:16) minutes in the PPH group and 28 (0:12 – 1: 29) minutes in the Ferguson
group (p= 0.138). The median estimated blood loss was 10 (0-200) ml in the PPH group
and 20 (0-200) ml in the Ferguson group (p=0.071). There were no differences in the
length of hospital stay. The most common adverse events were urinary retention (7% in
Ferguson; 10% in PPH), constipation (12% in Ferguson; 4% in PPH), and
dysuria/micturation disorder ((% Ferguson; 2% PPH). Patients in the Ferguson group
were more likely to present more than one adverse event (p=0.029). There were no
infections or episodes of fecal incontinence in either group. Patients in the PPH group
had significantly less pain at every follow-up time and required less pain medication as
well. At days 7 and 14 of follow-up, the pain was lower than the baseline in this group.
Pain was also significantly less pain at the time of initial bowel movement in the PPH
group (p= 0.008).
The full trial results was subsequently presented in the ASCRS meeting, in 2003 (15).
One hundred fifty-six patients had been randomized and completed surgery (77 PPH; 79
Ferguson); 18 were excluded from the protocol (Figure 1). The median follow-up time
was 2 months. There were no differences in age, race or gender between the two groups.
The main preoperative symptom was prolapse, followed by bleeding, mucus discharge
and fecal leakage in both groups. The mean operative time was 31 (0:05- 1:19) minutes in
the PPH group and 35 (0:12 – 1: 29) minutes in the Ferguson group (p=0.054). Mean
estimated blood loss was significantly less in the Ferguson group compared to the PPH
group (26; 0-200 ml vs. 47; 0-300 ml. p=0.016). Patients in the Ferguson group had
significantly more concomitant procedures than PPH patients (p=0.01). (Table 2).
The incidence of adverse events did not differ between the two groups and there was no
difference in the number of patients with more than one adverse event between the two
groups (35.1% PPH; 40.5% Ferguson: Table 3). The most common adverse event was
urinary retention (11.7% PPH; 7.6% Ferguson) followed by constipation (5.2% PPH;
12.7% Ferguson) and bleeding (9.1% PPH; 5.1% Ferguson). Seven (12%) patients in the
Ferguson group required return to the operating room vs. none in the PPH group
(p=0.007).
Patients who underwent PPH experienced significantly less pain than did patients in the
Ferguson group at every follow-up interval (Figures 2 and 3). Although patients who had
concomitant procedures experienced more pain than did patients who had only PPH, they
still had less pain than did patients in the Ferguson group. Moreover, at day 14, PPH
patients had significantly less pain compared to baseline (Figure 4). Patients in this group
also experienced lesser pain at the time of first bowel movement (p=0.003). The use of
analgesic was slightly higher in the PPH group at day one, after that however, patients in
the Ferguson group required more analgesics, especially at days 3 and 5 postoperatively
(Figure 5). There was no difference in the quality of life status between the 2 groups at
one month after surgery.
One hundred and five patients were available for 1 year outcome analysis (50 PPH and
55 Ferguson). Bleeding was more frequently seen in patients in the Ferguson group
during the first 6 months of follow-up, and in the PPH group at 12 months after surgery.
This was no statistically significant different. (Figure 6)
Prolapse was a complaint in about 2 % of the patients from both groups at 1 month after
surgery, increasing to 6.1% in the PPH group vs. 0% in the Ferguson group at 6 months,
and about 2.5 % in both groups at one year postoperatively. These findings were not
statistically significant (Figure 7).
Soiling was more common in patients who underwent Ferguson procedure at every
follow-up time, with no significant difference (Figure 8). Leakage was higher in the
Ferguson group during the first 6 months of follow-up, with complete resolution at one
year, whereas in the PPH group this rate progressively increased to 7.7% by 1 year
follow-up. Again, this was not significantly different.
Patients in the Ferguson group were more likely to present with new or worsening of
symptoms during the first 6 months following surgery, but at 12 month follow-up this
was more likely to occur in the PPH group, with no significant difference.
Beyond 30 days postoperatively 2.6 % of patients in the PPH group required additional
procedure compared to 5.1% in the Ferguson group. Table 3 summarizes the procedures
performed in both groups.
Conclusion
The American experience supports the safety and feasibility of PPH. Its advantages
relative to reduced pain and seemingly superior durability as compared to traditional
excisional hemorrhoidectomy are striking. Therefore, PPH has become the preferred
method of surgical treatment of hemorrhoids (16).
12
References
1) Johanson JF, Sonnenberg A. The prevalence of Hemorrhoids and Chronic
constipation. Gastroenterology, 1990; 98:380-386.
2) Jacobs DM, Burbinck MP, Onstad GR, et al. The relationship of haemorrhoids to
portal hypertension. Dis Colon Rectum, 1980; 23:567-569.
3) Thomson WHF: The nature of haemorrhoids. Br J Surg, 1975; 62: 542-552.
4) Longo A. Treatment of hemorrhoid disease by reduction of mucosa and
hemorrhoid prolapse with circular-suturing device: a new procedure. Proceedings
of the 6th World Congress of Endoscopic Surgery. Rome, June 3-6, 1998: 777-84.
5) Brown SR, Ballan K, Ho E, Ho Fams YH, Seow-Choen F. Stapled mucosectomy
for acute thrombosed circumferentially prolapsed piles: a prospective randomized
comparison with conventional haemorrhoidectomy. Colorectal Dis. 2001;3:175-
178.
6) Ho YH, Seo-Choen F, Tsang C, Eu KW. Randomized trial assessing anal
sphincter injuries after stapled haemorrhoidecotmy. Br J Surg, 2001; 88: 1449-55.
7) Franceschini F, Talamucci L, Dianda D, et al. Posterior perineal block for stapled
hemorrhoidopexy as an outpatient procedure. Osp Ital Chir, 2003;9:346-351.
8) Ho YH, Cheong WK, Tsang C, Ho J et al. Stapled hemorrhoidectomy: cost and
effectiveness. Randomized, controlled trial including incontinence scoring,
anorectal manometry, and endoanal ultrasound assessments at up to three months.
Dis Colon Rectum 2000;43: 1666-1675.
13
9) Carriero A, Dal Borgo P, Pucciani F. Stapled mucosal prolapsectomy for
hemorrhoidal prolapse with Lone Star Retractor System. Tech Coloproctol 2001;
5:41-46.
10) Cheetham MJ, Mortensen NJ, Nystrom PO et al. Persistent pain and faecal
urgency after stapled haemorrhoidectomy. Lancet. 2000 Aug 26;356:730-3.
11) Correa-Rovelo JM, Tellez O, Obregon L, et al. Prospective study of factors
affecting postoperative pain and symptom persistence after stapled rectal
mucosectomy for hemorrhoids: a need for preservation of squamous epithelium.
Dis Colon Rectum. 2003 Jul;46(7):955-62.
12) Carriero A, Longo A. Intraoperative, perioperative and postoperative
complications of stapled hemorrhoidopexy. Osp Ital Chir, 2003;9:333-340.
13) Singer MA, Cintron JR, Fleshman JW et al. Early experience with stapled
hemorrhoidectomy in the United States. Dis Colon Rectum. 2002;45:360-7.
14) Senagore A, Abcarian H, Corman M, et al. Safety of stapled hemorrhoidopexy:
initial results from a multicenter trial. Podium presentation, ASCRS, Chicago, Il.
June 3-8, 2002.
15) Senagore A, Singer M, Abcarian H. A prospective, randomized, controlled,
multicenter trial comparing stapled hemorrhoidopexy and Ferguson
hemorrhoidectomy: One year results. Presented at the ASCRS meeting, New
Orleans, LA. June 21-26, 2003.
16) Wexner SD. Invited commentary. The quest for painless surgical treatment of
hemorrhoids continues: is there an end to the pain in the end? J Am Coll Surg
14
2001; 193:174-7.

 

 

 

 
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A prospective, randomized, controlled multicenter trial comparing stapled hemorrhoidopexy and Fergus-01/05/2005
   
PPH en Suramerica. 15th Annual Colorectal Disease Symposium, Cleveland Clinic Florida-13/02/2004
   
PPH en USA. 15th Annual Colorectal Disease Symposium, Cleveland Clinic Florida-13/02/2004
   
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