Short Title: PPH Treatment of Hemorrhoidal Disease
Habr-Gama A, M.D., Silva e Sousa Jr AH, Rovelo JMC, Souza JS, Benício F, Regadas FSP, Wainstein C, Cunha TMR, Marques CFS, Bonardi RA, Ramos JR, Pandini LC, Kiss DR. Department of Gastroenterology, University of São Paulo Medical School, São Paulo, Brazil

Corresponding Author:
Angelita Habr-Gama, M.D.
Professor of Surgery
Department of Gastroenterology
University of São Paulo Medical School
Rua Manuel da Nóbrega, 1564
São Paulo-SP
Brazil 04001-005
Tel.: 5511-3887.1757
Fax: 5511-3884.8845
e-mail gamange@uol.com.br

Requests for reprints should be sent to Dr. Habr-Gama.

The authors received Proximate® 33mm hemorrhoidal circular stapler products from Ethicon Endo-Surgery. The authors did not receive any financial assistance in developing the protocol. Authors received some financial assistance in developing the manuscript.

STAPLED HEMORRHOIDECTOMY - INITIAL EXPERIENCE OF A LATIN AMERICAN GROUP

Habr-Gama A, M.D., Silva e Sousa Jr AH, Rovelo JMC, Souza JS, Benício F, Regadas FSP, Wainstein C, Cunha TMR, Marques CFS, Bonardi RA, Ramos JR, Pandini LC, Kiss DR. Department of Gastroenterology, University of São Paulo Medical School, São Paulo, Brazil

Treatment of hemorrhoidal disease depends largely on the severity of the disease. Conservative treatments such as dietary changes, rubber band ligation and infrared photocoagulation are preferred for first and second-degree hemorrhoids. Third and fourth degree hemorrhoids are generally surgically excised. Milligan and Morgan19, Ferguson8 and Parks operations are the most performed procedures around the world with satisfactory results concerning relief of symptoms but both are prone to complications, and are notoriously painful2,11,23,26. Modifications including addition of anal dilation and internal esfincterotomy, relaxants and new techniques are constantly sought to decrease postoperative pain but without significant improvement23. In 1993, Longo17 described the circular stapled hemorrhoidectomy using a specially designed stapling device named as PPH procedure for prolapse and hemorrhoids. The rational for stapled hemorrhoidectomy as suggested by Longo, is associated to important changes in concepts of pathogenesis of hemorrhoids and of surgical treatment. Internal hemorrhoids develop when cushions of vascular tissue in the anus undergo pathological change. These cushions have been considered as having an important role in maintaining anal continence because they act in conjunction with internal anal sphincter to allow the complete closure of the anal canal12,16,25. Stapled resection of a complete circular strip of mucosa above the dentate line, besides the reduction of the size of the hemorrhoidal cushions by interrupting their blood supply, is supposed to lift them into the anal canal. Whereas conventional surgical hemorrhoidectomy involves excision of hemorrhoidal plexus, anoderm and perianal skin, stapled hemorrhoidectomy simply excises a ring of rectal mucosa above the hemorrhoids. By avoiding multiple excisions and suture lines on the sensitive anal mucosa below the dentate line, pain appears to be far less with PPH than with conventional techniques3,9,10,13,14,15,17,18,20,22,23,24.

The purpose of the present study was to determine the value of circular hemorrhoidectomy (PPH procedure) based on prospective collected data during the initial experience of Latin American surgeons.

METHODS

A group of colorectal surgeons from Latin America participated in a scientific meeting organized by Ethicon Endo-Surgery, division of Johnson & Johnson, Brazil, to obtain detailed information on PPH. With the approval of the Ethics Committee of the University Hospital of the Medical School of São Paulo, three patients belonging to the Coloproctology Unit were operated on by Antonio Longo, M.D 17. A protocol study was designed for being applied prospectively by the surgeons attending to the meeting.

The Ethics Committee of each institution reviewed this protocol prior the start of the study. Patients with internal third and fourth degree hemorrhoidal disease were enrolled in the protocol. Patients with hemorrhoidal thrombosis, fissure, fistula or other anorectal pathologies or those immunosupressed were excluded. All patients were prepared to surgery with a phosphate enema and were given one prophylactic dose of intravenous cefoxitin or metronidazole. The procedure was performed under either a regional (epidural or intradural) anesthetic block or general anesthesia in a lithotomy or a jackknife position. The technique used in all procedures was that reported by Longo using the anal rectractor with the Proximate® HCS33 circular stapler (Ethicon Endo-Surgery, Cincinatti, OH. Only one endoanal purse string suture of 2-0 polypropilene was placed circumferentially 4 cm cranial to the anal verge taking mucosa and submucosa, avoiding gaps in the suture line. The stapler was introduced through the anus, the purse-string suture tied down onto the shaft of the instrument. The retraction of the suture pulled the attached rectal mucosa into the stapler. The instrument was closed and fired thus incorporating the mucosal tissue in the purse-string within the head of the gun. The circular knife excised the redundant tissue encompassed by the purse string and the anastomosis was accomplished by a double row of titanium staples. The instrument was withdrawn and the staple line was inspected for hemostasis. Any detectable bleeding area was sutured with monocryl sutures. When proeminent skin tags were present they were resected.

The excised tissue was sent for histopathological examination.

Data collected included demographic characteristics including symptoms of hemorrhoidal disease, bowel habits, anal continence, proctologic exam results, type of anesthesia, patient position and surgical details such as: duration of the operation (beginning with the intra-operative examination and cleansing of the anal canal until the end of procedure), distance from the stapling to the dentate line, need for complementary hemostasis, and any unexpected event. Postoperative data collected included degree of pain, spontaneous or associated to defecation, laxative consumption, presence of bleeding, fever, urinary retention or hematoma. Pain was evaluated by the type and dose of analgesics required. Each patient completed a written questionnaire about all these events.

Patients returned for the follow-up visits at days 7, 15, 30 and 90. Responses to pain, bleeding, fever, anal continence, symptoms, hemorrhoidal recurrence, and level of satisfaction were compiled. A rectal examination and sigmoidoscopy on days 15 and 30 were performed to assess, height and integrity of the suture line, presence of anal stenosis, abscess or anal fissure. Follow-up visits continued for a minimum period of three months after surgery.

RESULTS

A total of 177 patients treated from 2000 to 2001 were operated on and completed the study. There were 101 male. The average age was 47.7 years (range 26-85 years). Anal bleeding was the most common preoperative complaint (93.2%), followed by anal pain (60.2%), anal itching (43%) and constipation (41%). Two patients (1.1%) complained of diarrhea; two (1.1%) of incontinence for feces and five (2.8%) for flatus. Hemorrhoids were of third degree in 132 patients (74.6%), and of forth degree in 45 patients (25.4%). Skin tags were detected in 86 patients (48.8%) and rectoceles in 14 patients (7.9%).

The duration of the PPH procedure ranged from six minutes to two hours (average 23 minutes). The suture line was on average 3.8cm above the dentate line. No stapler failure was detected. Additional one or few sutures for hemostasis were required in 104 patients (58.7%). Resection of skin tags while undergoing PPH was performed in 86 cases (48.5%). Hospitalization was chosen for 140 patients which was for less than 24 hours in 128 (72.3%), for two days in 11 (6,2%) and for three days in 3 (1.6%). Day surgery was chosen for 37 patients (20.9%).

Analgesia with one to six doses of oral dipirona was enough for pain control in 126 patients (71.7%). Eighty-two patients (46.3%) required additional analgesia control and were given nonsteroidal anti-inflammatory drug (diclofenac or equivalent). No patient needed opiates for pain control. Analgesic usage decreased over time, especially by day 4. By day 7, majority of patients did not require analgesics.

Laxatives to ease defecation were given to 71.7% of the patients. The first defecation occurred after an average of 31 hours (ranging from 12 to 72 hours). First defecation requiring analgesia only with oral dipirona was reported by 46.9% of all patients. Bleeding related to the first defecation did not occur in 68 patients (38.4%). Non-defecation related bleeding occurred in 23 patients (13.2%). Bleeding was more frequent during the first three postoperatively days. Five patients (2.9%) required readmission to hospital and surgical intervention for bleeding control and one patient had to receive a blood transfusion. One episode of fever (>37.5oC) occurred in five patients (2.9%) which subsided without additional therapy. In one patient a localized suppuration above the staple line was detected on the day seven follow-up exam. The infection subsided following antibiotics prescription. Rectal examination on day 15 was not painful in 42.3% of patients and sigmoidoscopy revealed a complete line of staples still present in 6.6% of patients. Rectal exams and sigmoidoscopy on day 30 revealed complete healing of rectal mucosa in 33.6% of patients and in 40% evident hemorrhoid reduction. Eighty-two patients (46.3%) were reexamined six months after operation.

Incontinence for flatus was referred by one patient and for liquid feces by another. Although "soiling" was not recorded preoperatively, at day 7 thirteen patients and at day 30 three patients reported al least one soiling incident. After three months, no patients had hemorrhoidal prolapse or anastomotic stricture anastomosis upon rectal exam or fecal incontinence.

At day 30, 77,5% of patients rated the efficiency of the procedure to alleviate the preoperative symptoms as excellent; 16% as good; 5.3% as average and 1.2% as bad. At three months preoperatively, no patients had recurrence of hemorrhoidal prolapse, and stenosis or anal incontinence. Surgeons also rated the efficiency of the procedure as excellent in 75%; as good in 19.8%; average in 4.7%, and bad in 0.6%.

DISCUSSION

Although PPH is a relatively new technique, many studies have been published considering the procedure as an improvement in the treatment of hemorrhoidal disease13,15,17,20,21. Cheetham et al6 estimated that 50,000 stapled hemorrhoidectomy operations had already been performed in Europe until year 2000. The rational for this procedure is associated to important changes in concepts of surgical treatment of hemorrhoids. Complete circular strip of rectal mucosa above the dentate line is supposed to lift the hemorrhoidal cushions into the anal canal. Excision of hemorrhoidal excess tissue reduces obstruction of the canal as well as interrupting the blood flow to distal hemorrhoids thereby inhibiting symptomatic recurrence.

The experience with circular stapled hemorrhoidectomy in Latin America started in 2000 and progressively is being more widely used. Until July 2002, 1180 cases had been performed by a group of 30 surgeons. In the present study the experience with the first 177 cases operated on is presented. The technique was considered by the participant surgeons as easy to be learned and quick to be performed. Most operations lasted no more than 20 minutes with a mean duration of 23 minutes, with exception of one case that lasted two hours, in consequence of intraoperative hemorrhage difficulty in obtaining correct hemostasis. The operation time decreased with experience and when bleeding was not present it took no more than ten minutes. Intraoperative problems with exception of this case were minor. The only intercorrence was bleeding at staple line which was identified and requiring additional one or few sutures in 58.7% of patients. This was not considered as a complication but rather a routine part of the operation, since a careful revision of hemostasis is mandatory until complete dry suture line is achieved. Post operative bleeding requiring readmission to hospital occurred in 5 patients, four underwent surgical revision and one required blood transfusion. In the series presented by Ho et al13. Bleeding during hospitalization with staple technique was comparable to that observed with conventional treatment.

The correct placement of the purse string suture is the essential surgical point for the success of the operation. When it is placed very high it may decrease the probability of complete reduction of hemorrhoidal prolapse; if low, at 2 or less centimeters above the dentate line, postoperative pain is more often associated, part of the hemorrhoids being possible to be included and squamous epithelium may be found in the surgical specimen. In the present study the average distance of the suture line was 3.8 cm and no anoderm was found at histopathology. It is also essential not to be deeper than the submucosa. This caution also avoids inclusion of neighboring structures into the anastomosis particularly of the posterior wall of vagina. In patients with rectocele traumatic injury of the vagina may occur, inducing the formation of a rectovaginal fistula7. In our study PPH was performed in 14 patients with rectocele and this complication was avoided by palpating the vaginal wall before firing the stapler.

The main appointed advantage of stapled hemorrhoidectomy is the reduction of postoperative pain with return to earlier activity when compared with conventional procedure 1,4,7,10,14,15,18,21,22. Absence of trauma of the sensitive mucosa and of skin incision and suturing in less sensitive areas might be responsible for this reduced postoperative pain. Because of pain, conventional techniques oftenly require a 2-3 day hospitalization followed by 15 to 30 days for convalescence period22. Majority of the participants of the present study usually keep patients in hospital for a period of 24 to 72 hours for conventional hemorrhoidectomy; contrarily, with the PPH technique, over 92% of our patients were hospitalized for less than 24 hours, and some were not hospitalized at all since pain was not an issue. In seventy-one percent of the patients spontaneous pain was controlled only with oral dipirona, usually only necessary until day 4. Upon the first bowel movement almost half of the patients did not required extra dose or change of dipirona to other antiinflammatory nonesteroid drugs. Importantly prior to surgery majority of them were anxious and fearful of postoperative pain and about first defecation. Some studies have also reported statistically significantly less pain compared to conventional techniques1,4,7,13,18,21,22. Only one report to date has shown persistent pain following surgery6.

In the immediate postoperative days, one patient developed thrombosis of the external hemorrhoidal plexus and had to undergone a conventional excision at the 5th postoperative day. An adequate selection of patients is important factor for the success of this type of operation. Patients with thrombosed external hemorrhoids or associated infection should be excluded. Third degree or second degree hemorrhoids that do not respond to a non operative treatment are the best indication for stapled hemorrhoidectomy. Fourth degree hemorrhoids may be also treated but the patient has to be informed that pain is more expected and that the cosmetic result might not be ideal.

Sigmoidoscopy by days 15 and 30 revealed the staple line and the anal canal quickly healed by days 15 and 30. These results correlate well with the lack of pain and lack of symptoms reported by patients during this time.

Anal incontinence is a possible side effect of any hemorrhoidal procedure because dilation or retraction of the anal sphincter may cause injury to the sphincter. With PPH anal sphincter injuries can also occur by introduction of the stapler head13. At four years following Milligan-Morgan convention hemorrhoidectomy, minor continence was reported by 26% of patients by Bennett et al5. In the present study, anal incontinence was reported only by one patient and soiling by 13, but it was completely resolved in all patients after three months. Infection associated with hemorrhoidectomy is also a potential risk, even with the concomitant use of antibiotic prophylaxis. Because PPH involves stapled simultaneous closure of the wound and excision of the excess of tissue without any dissection, potential contamination of the wound is eliminated, thereby lowering the risk of infection. However, this complication may occur in consequence of hematoma formation. In our study all patients received preoperative intravenous antibiotics and only one patient presented a feverish peak which subsided quickly with use of oral antibiotics.

Because of complete alleviation of symptoms of hemorrhoidal disease, 93.5% of patients reported satisfaction with the procedure at day 30. Surgeons evaluation was rated as good to excellent in 94.8% of cases because of quick healing and few complications.

CONCLUSIONS

With a correct selection of patients, adequate and surgical technique, stapled hemorrhoidectomy may be considered as a safe procedure, easy to be learned with a satisfactory degree of pain concerning the use of analgesics and good acceptance by patients and surgeons. However, prospective, randomized, comprehensive studies focusing on potential problems such as achieving optimal hemostasis, equipment cost, and long-term results will clarify additional potential benefits of PPH for both patients and physicians.

ABSTRACT

Purpose: The purpose of the present study was to determine the value of circular hemorrhoidectomy (PPH) based on prospective collected data during the initial experience of Latin American surgeons.

Patients and Methods: PPH procedure was performed using the circular stapler in 177 patients with third and fourth degree of hemorrhoidal disease from 2000 to 2001. The average age was 47.7 years (range 26-85 years). Anal bleeding was the most common preoperative complaint (93.2%), followed by anal pain (60.2%), anal itching (43%) and constipation (41%). Hemorrhoids were of third degree in 132 patients (74%) and of fourth degree in 45 patients (25.4%). Skin tags were detected in 86 patients (48.8%) and rectocele in 14 patients (7.9%). The technique used was that described by Longo. Data collected included demographic characteristics of patients, type of anesthesia and surgical details such as duration of the operation, distance from the stapling to the dentate line, need for complementary hemostasis, and any unexpected event. Postoperative data collected included degree of pain, evaluated by the type and dose of analgesics required, laxative consumption, presence of bleeding, fever, urinary retention or hematoma. Each patient completed a written questionnaire about all these events.

Patients returned for the follow-up visits at days 7, 15, 30 and 90. Responses to pain, bleeding, fever, anal continence, hemorrhoidal recurrence, and level of satisfaction were compiled.

The duration of the procedure ranged from six minutes to two hours (average 23 minutes), most lasted no more than 20 minutes, with exception of one case, that lasted two hours in consequence of intraoperative bleeding. Intraoperative problems were minor. Additional one or few sutures was required in 58.7% of patients to achieve a perfect hemostasis. In 128 patients (72.3%), hospital stay was less than 24 hours. Day surgery was chosen for 37 patients (20.9%).

Pain was controlled with analgesia only with one to six doses of oral dipirona in 126 patients.

Five patients were readmitted to hospital, four for bleeding control and one for conventional hemorrhoidectomy due to an acute episode of external hemorrhoidal thrombosis.

At day 30, 77,5% of patients rated the efficiency of the procedure to alleviate the preoperative symptoms as excellent; 16% as good; 5.3% as average and 1.2% as bad. At three months peroperatively, no patients had recurrence of hemorrhoidal prolapse and stenosis or anal incontinence. Surgeons also rated the efficiency of the procedure as excellent in 75%; as good in 19.8%; average in 4.7%, and bad in 0.6%.

CONCLUSION

With a correct selection of patients, adequate stapler technique, stapled hemorrhoidectomy may be considered as a safe procedure, easy to be learned with a satisfactory degree of pain and good acceptance by patients and surgeons.

KEY WORDS: Hemorrhoids, PPH circular stapler.

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