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Long-term Results After Stapled
Hemorrhoidopexy: A Prospective Study With
a 6-Year Follow-up

A. Ommer, M.D.1 • Jakob Hinrichs, M.D.1 • Horst Mo¨llenberg, M.D.1Babji Marla, M.D.2 • Martin Karl Walz, M.D.1 1 Department for Surgery and Center for Minimally Invasive Surgery, Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Essen, 2 Center for Proctology, Essen-Ru¨ttenscheid, Essen, Germany BACKGROUND: Stapled hemorrhoidopexy was
patients (87.1%) were satisfied or very satisfied with the introduced in 1998 as a new technique for treating operation outcome; 19 patients (8.5%) were moderately advanced hemorrhoidal disease. Despite a clear satisfied; and 10 (4.5%) were not satisfied. Regarding perioperative advantage regarding pain and patient preoperative anal symptoms, complete relief was comfort, literature reviews indicate a higher recurrence observed in 179 patients (80.6%) for prolapse, 172 rate for stapled hemorrhoidopexy than for conventional (77.5%) for bleeding, 139 (85.3%) for mucus discharge, 139 (78.5%) for burning sensation, and 115 (75.5%) foritching. Considering all recorded symptoms, 194 patients OBJECTIVE: Our aim was to present long-term on the use
(86.6%) reported absence and or an improvement at follow-up. Twelve patients (5.4%) reported newly DESIGN: Observational study.
developed incontinence in the sense of urge symptoms;42 patients out of 51 patients (82.4%) with preexisting SETTING AND PATIENTS: Consecutive patients with
incontinence reported an improvement. Local or topical hemorrhoid prolapse treated at a regional surgical centerfrom May 27, 1999, through December 31, 2003.
retreatment (ointment, suppositories, sclerotherapy) wasperformed in 48 patients (21.4%). Reoperation for INTERVENTION: Stapled hemorrhoidopexy with
residual or newly developed hemorrhoidal nodules was accompanying resection of residual hemorrhoidal LIMITATIONS: Lack of a comparative group.
MAIN OUTCOME MEASURES: Standardized patient
questionnaire regarding satisfaction, resolution of
CONCLUSION: Our long-term results show that this
symptoms, and performance of further interventions.
strategy for stapled hemorrhoidopexy can achieve a highlevel of patient satisfaction and symptom control, with a RESULTS: Of 257 patients (82 female, 175 male, mean age
low rate of reoperation for recurrent hemorrhoidal 53 Ϯ 13 years) undergoing stapled hemorrhoidopexy, follow-up data were available for 224 patients (87.2%)with a mean duration of 6.3 Ϯ 1.2 years. Of these, 195 KEY WORDS: Hemorrhoidal disease; Bleeding; Prolapse;
Stapled hemorrhoidopexy; Incontinence; Long-term
Financial Disclosure: None reported.
Correspondence: A. Ommer, M.D., Department for Surgery and Center
for Minimally Invasive Surgery, Kliniken Essen-Mitte, Evang. Huyssens-
Stiftung, Henricistr. 92, D-45134 Essen, Germany. E-mail: aommer@
Stapledhemorrhoidopexywasintroducedin1998asa gentle new technique for treating advanced hemor-rhoidal disease.1 Unlike conventional surgical tech- niques, this procedure did not aim to remove but to repo-sition the prolapsed hemorrhoidal tissue. In several studies, this procedure was reported to offer advantages DOI: 10.1007/DCR.0b013e3182098df2The ASCRS 2011 with regard to postoperative pain and length of in-patient DISEASES OF THE COLON & RECTUM VOLUME 54: 5 (2011) OMMER ET AL: LONG-TERM RESULTS AFTER HEMORRHOIDOPEXY stay.2–7 However, recent reviews note a higher rate of re- TABLE 1. Accompanying procedures performed during
currence with stapled hemorrhoidopexy than with con- anesthesia in 257 patients undergoing stapled ventional methods in short-term follow-up.8–12 In our hospital, stapled hemorrhoidopexy was previously estab- lished as an integral part of hemorrhoid treatment in 1999.
This circumstance provided the impetus for presenting our experiences and long-term results with this surgical PATIENTS AND METHODS
The study included consecutive patients who underwent stapled hemorrhoidopexy at our institution from May 27,1999, through December 31, 2003. The indication forthe procedure was nonfixed circumferential hemorrhoid women; mean age (Ϯ SD), 53 Ϯ 13 (range, 19 – 88) years.
This group included approximately 70% of all patients un- Perioperative data were collected retrospectively for dergoing surgical intervention for grade III hemorrhoidal patients treated before September 2001 and prospectively disease in our hospital. The perioperative data were col- for patients treated after this date. The following variables lected retrospectively for 78 patients (30.4%) treated be- were recorded: age, gender, grade of hemorrhoidal disease, fore September 2001 and prospectively for 179 patients previous treatment, local symptoms, continence disorders (classified according to Parks13 as grade 1, incontinence of Of the total 257 patients, 70 (27.2%) had been previ- gas; grade 2, incontinence of gas and liquid stool; or grade ously treated only by topical measures (ointments or sup- 3, incontinence of gas, liquid, and solid stool), and defeca- positories); 168 patients (65.4%) had previously under- tory disorders such as obstructed defecation or slow-tran- gone sclerotherapy; 6 patients (2.3%) had undergone sit constipation. When necessary, slow-transit constipa- minor surgical procedures such as hemorrhoidal artery li- tion was confirmed by measurement of intestinal transit gation, rubber band ligation, or thrombectomy; and 13 time with the Hinton test,14 for which patients received patients (5.1%) had undergone a previous hemorrhoid op- pellets with 10 markers each from days 1 to 6, and an x-ray eration (Parks or Milligan-Morgan procedure in 12, sta- of the abdomen on day 7. A passage time of more than 60 pled hemorrhoidopexy in 1 patient). Local symptoms hours led to the diagnosis of slow-transit constipation.
noted were intermittent anal bleeding or prolapse of hem- The operating procedure was performed with a orrhoidal tissue or anal mucosa in 255 patients (99.2%), PPH-01 stapler from Ethicon Endo-Surgery (Norderstedt, mucus discharge in 179 (69.5%), burning sensation in 198 Germany), as described in the literature.1 The operations (77.0%), and itching in 129 patients (50.2%). A total of 63 were performed under general anesthesia or spinal anes- patients (24.5%) had continence disorders (Parks classifi- thesia. Intraoperative colonoscopy was offered to all pa- cation grade 1 in 50 (19.5%), grade 2 in 12 (4.7%), and tients who had not undergone recent colonic diagnostic grade 3 in 1 patient (0.4%). There was evidence of a def- examination. In the prospectively evaluated patients, pain ecatory disorder in 103 patients (40.1%): 93 patients intensity was assessed on a visual analog scale from 1 to 10.
(36.2%) had signs of obstructive defecation disorder (in- A standardized follow-up questionnaire was mailed to creased straining, incomplete evacuation) and 10 patients patients or filled out at an outpatient clinic visit. If the (3.9%) had slow transit constipation confirmed by the questionnaire was not returned, patients were asked to complete the questionnaire in a telephone interview. Thequestionnaire contained items concerning satisfaction, Perioperative Period
current symptoms, fecal continence, defecatory disorders, The mean operating time was 17 Ϯ 7 minutes. Of the 257 therapeutic interventions for recurrence, and questions re- operations, 238 (92.6%) were performed under general garding patients’ retrospective assessment of the painful- anesthesia, with only 19 (7.4%) performed under spinal ness of the stapled hemorrhoidopexy procedure.
anesthesia. Procedures accompanying the stapled hemor-rhoidopexy are listed in Table 1. In 3 patients (1.2%), the RESULTS
row of staples had to be oversewn with interrupted suturesbecause of partial dehiscence. In 18 patients (7.0%), resid- Patient Characteristics
ual hemorrhoidal nodules that had not been perfectly re- Stapled hemorrhoidopexy was performed in 257 consecu- positioned were removed by conventional resection (Table tive patients with grade III hemorrhoids: 175 men, 82 1). No other intraoperative complications were observed.
DISEASES OF THE COLON & RECTUM VOLUME 54: 5 (2011) TABLE 2. Postoperative urinary retention in 257 patients
undergoing stapled hemorrhoidopexy
bPlacement of indwelling catheter for 1 night or more.
Bleeding complications requiring surgical intervention oc- curred in 10 patients (3.9%). A total of 51 patients (19.8%)had urinary retention (Table 2).
Reoperations in the early postoperative phase up to 3 months were required in 6 patients (2.7%): 1 male patienthad hemorrhoidal thrombosis on postoperative day 12, 1female patient received ventral mucosectomy because of incomplete repositioning, in 1 female patient the ventral staple was split after 3 weeks because of a defecatory disor-der, and 3 patients had anal revision because of local pain.
FIGURE 2. Perioperative analgesic consumption (additional opioid/
Two of the early reoperations involved conventional resec- metamizole analgesia requirement) in addition to backgroundanalgesia with a nonsteroidal anti-inflammatory drug. Data were tion of residual, imperfectly repositioned nodules. No rel- collected retrospectively for 78 patients and prospectively for 179 evant wound infections or stenoses of the row of staples All patients received background analgesia with a non- steroidal anti-inflammatory drug (e.g., diclofenac). Addi-tional consumption of analgesics (metamizole, tramadol, influence on the pain score, whereas patients with an ac- or possibly piritramide) was low: 170 patients (66%) man- companying anal procedure (extensive anal tag removal, aged without additional analgesics on the first postopera- fissurectomy, or conventional resection of residual hemor- tive day, and 203 (79%) on the second postoperative day rhoidal nodules) tended to have higher pain scores than those without (day 0, 5.2 vs 4.5; day 2, 2.5 vs 2.1). The mean In the 179 prospectively evaluated patients, the mean inpatient hospital stay was 4.2 Ϯ 1.7 (1–14) days. The pain intensity score on the visual analog scale was 4.7 Ϯ 2.4 length of hospital stay was related to changes in the Ger- on the day of the operation, 3.0 Ϯ 1.0 on the first postop- man hospital financing system, which after 2003 paid for a erative day, and 2.3 Ϯ 1.5 on the second postoperative day.
stay of 2 nights for this surgical category according to the An intraoperative colonoscopy (air insufflation) had no DRG-system, whereas previously the hospital was paid foreach day at the hospital.
Follow-up Evaluation
A total of 224 (87.2%) of the 257 patients were included in the follow-up analyses. Of these, 89 patients (39.7%) re-turned the questionnaire by mail, 81 (36.2%) completed the questionnaire at a clinic visit, and 54 patients (24.1%) completed a phone interview. Follow-up data were notavailable for 33 patients (12.8%): 8 patients died of an un- related cause, and 25 patients had moved away without aforwarding address. The mean follow-up period was 6.3 1.2 (median, 6; range, 4.2–9.5) years (Fig. 1).
Of the 224 patients included in the follow-up evalua- tion, 141 (62.9%) stated that they were “very satisfied”with the outcome, 54 patients (24.1%) reported being “sat- isfied,” 19 patients (8.5%) were only moderately satisfied, and 10 patients (4.5%) were dissatisfied. The relationshipbetween satisfaction and residual symptoms or reinterven- FIGURE 1. Length of follow-up for 224 patients after stapled
hemorrhoidopexy for advanced hemorrhoidal disease.
OMMER ET AL: LONG-TERM RESULTS AFTER HEMORRHOIDOPEXY TABLE 3. Number of patients with residual symptoms or reintervention in relation to degree of satisfaction with the surgical procedure
Data are number of patients with residual symptoms or reintervention as a proportion of patients for whom data were available in each satisfaction category, with percent-ages in parentheses.
Most preoperative hemorrhoidal problems had been 132 patients (58.9%) had no problems. A total of 92 resolved at follow-up (Table 4). Overall, approximately (41.1%) patients had preexisting disorders, which had im- 80% of patients with bleeding or prolapse before surgery proved in 62 patients (27.7% of the follow-up group), re- were completely symptom-free at follow-up, and approx- mained unchanged in 26 (11.6%), and worsened in 4 imately 15% showed improvement. In patients with both (1.8%). Three patients (1.3%) reported a newly developed bleeding and prolapse, 69.9% were completely symptom- defecatory disorder. No anal stenosis was detected in any of free and 90.2% were asymptomatic or improved at follow- these cases. One additional female patient could be cured up. Taking into account all the recorded hemorrhoidal by cutting the ventral staple line in a rectocele.
symptoms, 194 (86.6%) of the patients were symptom-free Follow-up evaluations showed that repeat hemor- rhoid operations had been performed in a total of 8 (3.6%) Of the 224 patients for whom follow-up data were of the 224 patients. In addition to the 2 early reoperations, available, 52 patients (23.2%) had fecal continence prob- 5 repeat hemorrhoid operations involved conventional re- lems: Preoperative problems had improved in 42 patients section of residual, imperfectly repositioned nodules be- (18.8% of the follow-up group), remained unchanged in tween 2 and 4 years after the first operation, and 1 case 6 patients (2.7%), and had worsened in 4 patients (1.8%).
involved repeated stapled hemorrhoidopexy 4 years after New problems, mainly urge incontinence, developed in the first procedure in a mentally disabled patient with a 11 patients (4.9%). With regard to defecation disorders, severe defecatory disorder, because of a recurrent prolapse TABLE 4. Postoperative hemorrhoidal symptoms at long-term follow-up in relation to preoperative status
DISEASES OF THE COLON & RECTUM VOLUME 54: 5 (2011) caused by excessive straining. Secondary removal of anal more recent report26 found these problems to be generally skin tags was performed in 7 patients (3.1%). Four other patients had another anal operation unrelated to the pre- In our patient population, the complication rate for vious operation during the follow-up observation period stapled hemorrhoidopexy was low. Although the overall (fissurectomy in 3, abscess excision in 1). Reapplication of rates for rebleeding and urinary retention for the entire topical or local ointments, suppositories, or intermittent study appear relatively high, it should be noted that the sclerotherapy was required for another 50 patients (22.3%).
study period included the learning curves of the responsi- Of the 224 patients asked at follow-up to evaluate their ble surgeons. Evaluation of patients who underwent this remembered postoperative pain experience, 52 (23.2%) operation between 2007 and 2009 showed that improve- reported not having experienced any pain, and pain sever- ments in the operating technique and perioperative anal- ity was rated as mild in 117 (52.2%), more severe in 45 gesia greatly reduced the number of patients with urinary (20.1%), and “almost unbearable” in 10 patients (4.5%).
retention to 10% (6% requiring catheter placement, 4% These data were consistent with the pain scores recorded medication; data not shown). No life-threatening compli- on the visual analog scale during the early postoperative cations were observed, and the rate of early reoperations period: The mean pain score on the second postoperative was low at 2.7%, including patients with reintervention for day was 1.7 for those who retrospectively reported having incomplete repositioning or anal pain.
had no pain, 1.9 for those who reported having had mild Our study also showed a low pain intensity associated pain, 2.7 for those with severe pain, and 3.6 for those who with stapled hemorrhoidopexy. It is interesting to note that, although 75% of patients retrospectively reported The mean period of incapacity for work from the day having had only mild pain, 4.5% remembered very severe of the operation was 18.7 Ϯ 13.4 (median, 15; range, pain, which was also verified by the pain scores recorded perioperatively. Intensive pain medication thereforeseems to be essential to meet the needs of some patients.
However, pain sensation is a highly subjective feeling.
This is reflected in the wide variation in the time to An advantage in regard to perioperative pain and patient resume work, which was ranged from 3 to 106 days after comfort has been found for stapled hemorrhoidopexy compared with other surgical methods in numerous ran- Equally interesting are the findings relating to fecal domized trials.9–12 However, in 2004, Nisar et al15 pointed continence: 4.5% of patients complained of persistent urge out the limited long-term results with stapled hemorrhoi- incontinence, which is consistent with the experiences of dopexy and declared that conventional hemorrhoid sur- other authors.26 At the same time, however, a large num- gery remained the “gold standard” for management of ber of patients with preexisting incontinence reported an hemorrhoids. Stapled hemorrhoidopexy was rated as improvement. The removal of an internal mucosal pro- less effective than hemorrhoidectomy, with its advan- lapse by the mucosal resection may have played a decisive tage lying mainly in the lower intensity of perioperative role in this improvement. Similar results were found for pain. Despite the advantages of stapled hemorrhoid- defecation, which were consistent with the report by Bona opexy in relation to postoperative pain, operating time, et al27 regarding outlet obstruction.
and faster convalescence, numerous studies found The available publications and resulting reviews of sta- higher rates of reintervention and recurrent pro- pled hemorrhoidopexy largely deal with short-term results lapse.8,10,12,16 –18 However, such reviews have provoked (up to 2 years postoperatively), and long-term results con- tinue to be rare. Jongen et al28 reported a long-term reop- The extensive discussion of stapled hemorrhoidopexy eration rate of 3.4% for persistence or recurrence of hem- has also been stimulated by numerous publications con- orrhoidal prolapse. In a study of 216 patients in which 193 cerning complications. A collection of adverse events after (89%) were followed for a median period of 28 months, hemorrhoid operations, which was published in 2006,20 Fuegisthaler et al29 observed a high satisfaction rate of mentioned 7 cases of retroperitoneal sepsis after stapled 89%. However, these authors pointed out a very high rate hemorrhoidopexy, 1 with a fatal outcome. This is un- of residual symptoms: persistent prolapse in 24%, fecal doubtedly a procedure that makes high technical demands urgency in 40%, pain in 25%, and local discomfort in 38%, on the surgeon.21,22 Notably, incontinence—the compli- with a reoperation rate of 5%. The main symptoms had cation most feared by patients— has been reported in 0% disappeared in 66% and improved in 28%. A Danish pub- to 28% of patients after stapled hemorrhoidopexy.23 Reop- lication30 in 258 patients with a median follow-up of 34 erations described in the literature mainly occurred the months also described high patient satisfaction, but no fur- immediate postoperative period.24 Although a high num- ther details are given. Interventions because of recurrence ber of patients with urge incontinence and persistent pain were mainly performed in the first year: 12% of the have been reported after stapled hemorrhoidopexy,25 a patients underwent repeat stapled hemorrhoidopexy and OMMER ET AL: LONG-TERM RESULTS AFTER HEMORRHOIDOPEXY another 14.7% had conventional resection. However, the currence rates reported in the literature are often due to crucial weakness of this study is the low clinical follow-up misidentification of residual skin tags. Further reviews8,9,18 rate: although 48% of the patients could still be reached report a numerically significantly higher reoperation rate after 2 years, the rate fell to 26.5% after 5 years and was after stapled hemorrhoidopexy than after Milligan-Mor- hence unacceptable for scientific purposes. Picchio et al31 gan resection. Nisar et al15 described a significantly higher contacted 74 patients by phone or clinic visit for 5-year rate of recurrent prolapse for stapled hemorrhoidopexy follow-up of a randomized study comparing stapled hem- than for Milligan-Morgan (third-degree, 11% vs 0%; orrhoidopexy with the Milligan-Morgan operation. No fourth-degree, 50% vs 0%), but indicated no correlation differences in pain, bleeding, or patient satisfaction were with revision operations or renewed conservative thera- found. In 2008, Bona et al27 described a reoperation rate peutic measures. In the randomized studies, follow-up for patients with early postoperative bleeding of only 1%, data regarding reoperations are often not given, although with an overall reoperation rate of 4.2% after a median such data are contained in some reports.35,36 In their study follow-up of 6.1 year. Ceci et al32 contacted 291 patients of patients with fourth-degree hemorrhoids Ortiz et al35 with a mean follow-up of 73 months after stapled hemor- reported recurrence of prolapse in 8 of 15 patients, 5 of rhoidopexy and found that 65.3% of patients were asymp- whom underwent conventional reoperation. The tendency tomatic, 25% had mild symptoms, and 9.3% had pro- is to regard this outcome as a technical failure of stapled nounced symptoms. Recurrence was diagnosed in 18.2%.
hemorrhoidopexy. However, the total number of reopera- The overall reoperation rate was 7.2%, and the rate was tions comprises a large number of diseases which are at- greatly higher in patients who entered the study with tributable partially to stapled hemorrhoidopexy but also fourth-degree hemorrhoids than in those with third- to other changes. This makes it difficult to differentiate degree hemorrhoids (13.7% vs 2.4%, P ϭ .001).
clearly between reoperations caused by technically inade- Against this background, the present study—with a quate repositioning, intentional or inadvertent failure to follow-up time of 6.3 years and a follow-up rate of 87.2% eliminate changes, or newly developed changes following (224 patients)—is to our knowledge the longest and most extensive long-term study of stapled hemorrhoidopexy yet Overall, good long-term results have been achieved undertaken. We found a high patient satisfaction rate of with stapled hemorrhoidopexy. Some of the cases in which nearly 90%. The overall reoperation rate of 3.6% was low.
symptoms were poorly controlled are likely due to techni- Reoperation was mainly due to residual prolapsed seg- cal problems with the operation, as outlined above (posi- ments, particularly ventrally, that were not adequately re- tion of the row of staples, inadequate repositioning of in- positioned by the mucosal resection. This technical prob- dividual segments, residual anal tags). Hence the surgeon’s lem was also evident in the relatively high proportion experience plays an important role in determining the (7.8%) of additional conventional procedures required for outcome. Although no reference group with conven- residual hemorrhoidal segments during the first operation, tional results was available for comparison in the pres- at the expense of higher pain intensity. The advantage of ent study, our results were similar to those for Ferguson this strategy in preventing recurrence is supported by a hemorrhoidectomy37 at the expense of higher periopera- recent publication by Garg.33 Indeed, some so-called re- currences may be caused by technical problems with the Patient satisfaction is a multifactorial criterion and de- operation. For example, in both of our patients who un- pends not only on perioperative progress but also on sub- derwent repeated hemorrhoidopexy, the position of the jective perception. We found that the “success” of the op- staple line was high, which might have caused insufficient eration does not necessarily determine whether patients repositioning of the hemorrhoidal tissue. A similar prob- are satisfied or dissatisfied (Table 3). A wide variety of fac- lem is posed by perianal skin tags, which are regarded by tors probably play a role. It is difficult to quote a “recur- some authors as a relative contraindication for stapled rence rate” on the basis of the data collected. For instance, hemorrhoidopexy because they need a separate resection the recurrence rate can be given as the overall reoperation or are interpreted as false recurrence.28,34 In our patient rate (8 patients, 3.6%), but also as the percentage of pa- population, removal of anal tags was performed simulta- tients with residual symptoms in regard to bleeding and neously with stapled hemorrhoidopexy in 19.5% of the operations. In some patients, this also led to higher inten-sity of postoperative pain. However, only 2.7% of patients CONCLUSION
subsequently required secondary anal tag removal, mainlyperformed under local anesthesia.
Nearly 90% of our patients were satisfied with the out- The problem of surgical intervention for recurrence is come of their treatment. Complete freedom from typical inadequately tackled in the literature. A recent meta-anal- hemorrhoidal symptoms was achieved in around 80% of ysis7 dealing with the problem of differentiation between patients and a further 15% found their symptoms im- residual skin tags and recurrence concluded that high re- proved. These data are similar or even better than those DISEASES OF THE COLON & RECTUM VOLUME 54: 5 (2011) presented from large series of patients treated with con- Meeting 27 November 1974. President’s Address. Anorectal in- ventional surgical techniques. We conclude that stapled continence. Proc R Soc Med. 1975;68:681– 690.
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ª The Author 2008. Published by the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: Advance Access publication November 26, 2008Cancer Risk After Exposure to Treatments for Ovulation InductionR. Calderon-Margalit, Y. Friedlander, R. Yanetz, K. Kleinhaus, M. C. Perrin, O. Manor, S. Harlap, andO. Pa

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1. Electronic cards: an unrelenting run In the field of electronic cards, payment cards stride forward: during 2002 their number was superior to 46 millions, and there were more than 24.5 million debit cards - almost all of which POS suitable - and 21,8 million credit cards of which 53,34% actually active – which means those used at least once per year. The gap between issued credit card

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