A Randomized Trial of Transanal Hemorrhoidal Dearterialization With Anopexy Compared With Open Hemorrhoidectomy in the Treatment of Hemorrhoids

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1 ORIGINAL CONTRIBUTION A Randomized Trial of Transanal Hemorrhoidal Dearterialization With Anopexy Compared With Open Hemorrhoidectomy in the Treatment of Hemorrhoids Solveig E. Elmér, M.D. Jonas O. Nygren, M.D., Ph.D. Claes E. Lenander, M.D., Ph.D. Department of Surgery, Ersta Hospital, Institute of Clinical Sciences at Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden BACKGROUND: Doppler guidance in hemorrhoidal surgery has become more frequent during the past decade. The method is mainly studied in nonrandomized trials. Data from randomized controlled trials are lacking. OBJECTIVE: The aim of this study was to compare early and midterm results of transanal hemorrhoidal dearterialization with anopexy to open hemorrhoidectomy. DESIGN, SETTINGS, PATIENTS, AND INTERVENTIONS: Forty patients with grade to 3 hemorrhoids were randomly assigned to transanal hemorrhoidal dearterialization with anopexy (group A, n = 0) or open hemorrhoidectomy (group B, n = 0). A diary was used during the first postoperative weeks. A Funding/Support: This study was supported financially by the Stockholm Council Public Health and Medical Services Committee R&D Department. Financial Disclosure: Dr Lenander has demonstrated the surgical technique on 1 occasion at a scientific meeting at Karolinska University hospital (without reimbursement) and on 3 occasions to smaller groups of surgeons in smaller hospitals. During those latter occasions, he was reimbursed from the THD Company for the loss of income on that day only (leave without pay from his employer). All this was after the completion of this study and after collection of the data. Drs Elmér and Nygren have no conflicts of interest or financial ties to disclose. self-reported symptom questionnaire was answered, and a clinical examination was performed preoperatively, after to months, and after 1 year. MAIN OUTCOME MEASURE: The main outcome measure was postoperative pain. RESULTS: Postoperative peak pain was lower in group A during the first week than in group B (p < 0.05), whereas no difference in overall pain was noted. More patients expressed normal well-being in group A (p = 0.05). Pain, bleeding, and the need for manual reduction of the hemorrhoids were all improved in both groups after 1 year (p < 0.05). Soiling had decreased after both methods at early follow-up. After 1 year, soiling was significantly decreased only after open hemorrhoidectomy. The grade of hemorrhoids was significantly reduced after 1 year for both methods, but there was a trend to more patients with remaining grade hemorrhoids in group A (p = 0.0). LIMITATIONS: There was no blinding, the sample size was small, and follow-up was for only 1 year. The questionnaire was not validated. CONCLUSION: The difference in postoperative pain between transanal hemorrhoidal dearterialization with anopexy and open hemorrhoidectomy may be less than expected based on previous literature. Presented at the meeting of the European Society of Coloproctology, Nantes, France, September to 7, 00. Published as an abstract in Colorectal Dis. 00;10(suppl). Clinical Trial Registration: Karolinska Clinical Trial Registry CT0091. Correspondence: Solveig Elmér, M.D., Department of Surgery, Ersta Hospital, Box, S-1191, Stockholm, Sweden. solveig.elmer@erstadiakoni.se Dis Colon Rectum 013; 5: 90 DOI: /DCR.0b013e317a57 The ASCRS 013 KEY WORDS: Hemorrhoids; Hemorrhoidectomy; Postoperative pain; Doppler; Transanal hemorrhoidal dearterialization; Anopexy. Hemorrhoidal surgery has evolved from more to less invasive surgery during the past decade. The use of Doppler guidance in hemorrhoidal surgery was introduced in the 1990s and has been further developed since. The Doppler-guided hemorrhoidal arterial ligation (DG-HAL) was described by Morinaga et Diseases of the Colon & Rectum Volume 5: (013)

2 Diseases of the Colon & Rectum Volume 5: (013) 5 al in By this technique, the submucosal terminal branches of the superior rectal artery are identified by using a Doppler flow meter and subsequently ligated. This causes a decrease in the arterial inflow to the piles, leading to shrinkage of the hemorrhoidal tissue and a reduction of the prolapsed mucosa. Transanal hemorrhoidal dearterialization (THD) is a similar method described by Sohn et al in 001, and, in 00, further developed by Dal Monte et al, 3 adding an anopexy of the prolapsed mucosa. Until now, several nonrandomized studies 3 9 performing these methods have reported good results and low postoperative pain, and low complication rates, as well. Only small randomized trials have been performed that describe short-term and midterm results of the DG-HAL operation. 10,11 In the present prospective randomized study, transanal hemorrhoidal dearterialization with anopexy () is compared with conventional open hemorrhoidectomy (). The primary outcome was postoperative pain. Secondary outcomes were postoperative well-being, operating time, return to work, complications, midterm symptom reduction, and restoration of anatomy. METHODS Study Design Between December 00 and November 007, 17 consecutive patients were scheduled for surgery of hemorrhoidal disease within the setting of a specialized coloproctologic department. All eligible patients with symptomatic second- to third-degree hemorrhoids were considered for a randomized study comparing with. The hemorrhoidal grade was estimated on a straining chair according to the Goligher classification (grade 1, hemorrhoids without prolapse or with prolapse into the anal canal; grade, hemorrhoids with prolapse outside of the anus and then spontaneously relapsing; grade 3, hemorrhoids prolapsing outside of the anus needing manual reposition; grade, hemorrhoids that were prolapsed outside of the anus). All cases were examined and performed as day-case surgery by 1 single colorectal surgeon (C.L.), who is well experienced in and in. The study was approved by the local ethics committee, and all patients signed a written informed consent. Inclusion criteria were symptomatic (bleeding, pain, pruritus, soiling, and prolapse) hemorrhoids grades to 3 requiring surgical treatment suitable for both and. Exclusion criteria were acutely thrombosed hemorrhoids, anal fissure, anal abscesses, anal fistulas, inability to understand the study instructions, age more than 0 years, continuous consumption of analgesics, IBD, fecal incontinence, anal stenosis, bleeding disorder, and rectal prolapse. Patients who had undergone rubber band ligation or sclerotherapy in the past 3 months, within 3 years, or any previous operation with HAL, THD, or stapled anopexy were excluded. Patient Selection Forty patients were included in the study. Of 17 patients that were not included, 59 were not considered suitable for both methods; 13 had previously undergone THD or stapled anopexy, 1 had other proctologic conditions, were not able to understand the instructions, 3 had IBD, and met other exclusion criteria as stated above. Ten patients were seen by a consultant other than C.L. in the office, and they were not included in the study. One patient cancelled the operation. The flow of all patients through the study is shown in Figure 1. Baseline characteristics are shown in Table 1. At the first visit, all patients were examined in the left lateral position and on a straining chair. An anoscopy and a rigid sigmoidoscopy were performed, and further investigation was done when thought necessary (eg, colonoscopy or CT colonoscopy). All hemorrhoids were classified grades 1 to 3, and the patients answered a standardized questionnaire comprising 35 questions covering bowel habits, continence, and anal function. Five questions concerned symptoms of hemorrhoids (anal pain, defecatory bleeding, anal pruritus, soiling, and replacement of the prolapse). Because no validated questionnaire for hemorrhoidal disease was available, we used a questionnaire used in clinical practice and in previously published studies. 1 The frequency of each symptom (never, less than once a week, 1 times per week, and every day (always)) was reported. Stratification for irritable bowel syndrome was done according to the Rome 3 criteria. Performance All operations were planned as day-case surgery, and a cleaning enema was given preoperatively. No antibiotics were given pre- or postoperatively. The randomization between THD and was done by a research nurse. Sealed envelopes were used and opened in the operating room. Surgery was performed under general anesthesia with the addition of a preoperative perianal block 13 in the lithotomy position. Open hemorrhoidectomy was performed without a retractor. The external component was grasped by a forceps, and the hemorrhoids were excised up to the anorectal ring by the use of diathermy for dissection and hemostasis. No ligations were performed, and the wounds were left open. The number of excisions was individualized ( large excisions in 9 patients and 3 excisions in 10 patients), and adequate mucosal and skin bridges were left between them. For arterial ligation and anopexy, the THD instrument (G.F. Medical Division, Corregio, Italy) was introduced to reduce the anal prolapse and to locate the arteries by using the incorporated Doppler probe. Six terminal branches of the superior rectal artery

3 Elmér et al: Thd/A vs Open Hemorrhoidectomy Assessed for eligibility (n = 17) Enrollment Excluded (n = 17 ) Not meeting inclusion criteria (n = 59) Not suitable due to exclusion criteria (n = 3) Declined to participate (n = 3 ) Excluded due to other reasons (n = ) Randomized (n = 0) Allocation Allocated to (n = 0) Received allocated intervention (n = 0) Did not receive allocated intervention (n = 0) Allocated to Open hemorrhoidectomy (n = 0) Received allocated intervention (n = 19) Did not receive allocated intervention (n = 1) (1 patient did not want to undergo surgery) Follow-up Lost to follow-up (n = 0) Discontinued intervention (n = 0) Lost to follow-up (n = 1) One patient did not wish to take part in follow-up Analysis Analyzed according to ITT principles (n = 0) Excluded from analysis (n = 0) Analyzed according to ITT principles (n = 1) Excluded from analysis (n = 0) FIGURE 1. Flow of all patients through the study. = transanal hemorrhoidal dearterialization with anopexy; ITT, intention to treat. (located at 1, 3, 5, 7, 9, and 11 o clock (anterior midline representing 1 o clock)) were identified and ligated with a figure- stitch in all cases except 1 ( ligations). With the same suture, an anopexy was performed by a continuous running suture making to mucosal stitches ending at least 5 mm above the dentate line. 3 The patients were discharged when pain relief was adequate, they were able to pass urine, and no early complication had occurred. A stool softener was advised, and TABLE 1. Baseline characteristics of patients THD (n = 0) (n = 19) Age, y, mean 5 55 Sex ratio (M:F) :1 :11 IBS, Rome III criteria 3 Degree of hemorrhoids Second 3 3 Third THD = transanal hemorrhoidal dearterialization; = open hemorrhoidectomy; IBS = irritable bowel syndrome. a scheduled analgesia consisting of 1 g paracetamol and 100 mg dextropropoxyphene times daily was recommended to be reduced gradually as needed. All patients were encouraged to return to work as soon as possible. For evaluation, the patient filled in a diary covering the first 1 postoperative days. Pain was scored daily on a Numerical Rating Scale (0 = no pain at all and 10 = the most severe pain imaginable). There were different pain scores for pain each day, one regarding the worst pain sensation that day (peak pain) and one in which the patients were asked to assess the average pain during the whole day (average pain). Well-being was assessed daily with a single question whether well-being was as normal or worse than normal. Dose of analgesics, any complications, whether or not they had returned to work, and any need to see a practitioner during this period were registered. A clinical evaluation was performed (by C.L.) after to 1 weeks (median, 1; range, 9 3) and after 1 months (median, 1; range, 11 15). The grade of hemorrhoids was estimated, and the patients answered the same questionnaire as before surgery.

4 Diseases of the Colon & Rectum Volume 5: (013) 7 Pain score (median) Postoperative day FIGURE. Peak pain scores for each group the first 1 postoperative days. Values are given as median. p < = transanal hemorrhoidal dearterialization with anopexy; = open hemorrhoidectomy. Statistical Analysis In a comparison of previous data on postoperative pain after 1 and data from our own institution on postoperative pain after, in a prestudy of 11 patients (data on file), a SD difference in postoperative pain scores was found between those procedures. Sample size calculation, with a power of 0. and α-level of 0.05, demonstrated that 17 evaluable patients were needed in each group, and thus 0 patients in each group were chosen for this study. Nonparametrical statistics were used (Wilcoxon signed rank test and Mann-Whitney U test for paired and unpaired comparisons) or Fisher exact test for crude associations between categorical variables. All analyses were made according to intention-totreat principles. RESULTS Early Postoperative Results Postoperative Pain and Well-being. Duration of surgery was longer for (3 vs 0 minutes p < vs ). The peak pain scores were significantly lower in the group for 5 days during the first week (p < 0.05 vs ) (Fig. ). A peak pain score of more than 3 was reported for a median of 7 days (range, 0 13) in the group in comparison with 1 days (range, 5 1) in the group (p = 0.010) The overall pain did not differ between the groups (Fig. 3). Significantly more patients presented normal well-being in the -group. In the group, patients reported normal well-being for a median of of 1 days (range, 0 13) and in the group for 3 of 1 days (range, 0 13) (p = 0.05) (Fig. ). The use of analgesics was similar among the groups. For the group, consumption of dextropropoxyphene continued until day 9 (median; range, 0 1) and for the group until day (median; range, 0 1) (p = NS). Fourteen of the 0 patients operated on with were working before the procedure, and they returned to work on day 1 (median; range, 1 5) in comparison with the group in which 10 of 19 patients worked, and they returned to work on day 1 (median; range, 1 ) (p = NS). Complications. Twelve patients had thirteen complications within the first 30 days; 7 patients developed urinary retention ( ; 3 ), 5 of them were admitted overnight (3 ; ), and of them required a urinary catheter for 3 days (1 ; 1 ) (Table ). Two patients in the group needed an extra visit to the hospital because of bleeding that, however, had stopped spontaneously. One patient in the group presented a thrombosed hemorrhoid, and another in the same group needed reintervention after days because of severe pain. Two sutures were found to be too close to the dentate line, and cutting of these resulted in pain relief. Three patients Pain score (median) Postoperative day FIGURE 3. Average pain scores for each group during the first 1 postoperative days. Values are given as median. p = NS. = transanal hemorrhoidal dearterialization with anopexy; = open hemorrhoidectomy; NS = not significant.

5 Elmér et al: Thd/A vs Open Hemorrhoidectomy Percent Postoperative day FIGURE. Proportion of patients reporting normal well-being during the first 1 postoperative days. p < = transanal hemorrhoidal dearterialization with anopexy; = open hemorrhoidectomy. in the group presented a partial reprolapse within the first week. In these, 1 or sutures had rifted the mucosa causing a partial reprolapse. For one of the patients, a reintervention with was scheduled, but the patient healed spontaneously. For the other, it was decided to wait until the 1-year follow-up, 1 patient was then successfully treated with rubber band ligation, and the other was scheduled for. Results from Follow-up Reduction of Symptoms and Residual Hemorrhoids. Each symptom was examined separately. Pain, bleeding, and the need for manual reduction of hemorrhoids were all improved in both groups after 1 year (p < 0.05). Soiling decreased in both groups after to months (p < 0.05). After 1 year, it was significantly decreased only after (Table 3). When examined on a straining chair preoperatively, 3/39 patients had hemorrhoids grade 3 in comparison with 0/39 patients when examined in the left lateral position. After 1 year, 3/39 patients had remaining grade 3 hemorrhoids examined on a straining chair in comparison with 1/39 in the left lateral position. The grade of hemorrhoids before surgery and after 1 year is shown in Figure 5. Only data from examination on the straining chair are given. At the 1-year follow-up, patients in the group had remaining grade 3 hemorrhoids in comparison with 1 patient in the group, whereas the TABLE. Operating time and postoperative complications (n = 0) (n = 19) Operating time, min, mean (range) 3 (30 5) 0 (10 3) Postoperative complications 5 Urinary retention 3 Secondary hemorrhage Thrombosed residual hemorrhoid 1 Partial reprolapse 3 Reoperation 1 = transanal hemorrhoidal dearterialization with anopexy; = open hemorrhoidectomy. number of patients with remaining grade hemorrhoids was 7 in the group versus 3 in the group. This apparent difference was not significant (p = 0.0). Complications and Reinterventions. Two patients with preoperatively circumferential hemorrhoids undergoing needed further treatment at to months follow-up; 1 patient had another, and the other was treated with rubber band ligation. Two patients in the group needed further surgery; 1 patient had a reprolapse at the first follow-up and was reoperated with, and the other had skin tags removed owing to hygienic problems. At the 1-year follow-up, 3 patients had rubber band or sclerotherapy ( ; 1 ). Four patients had a complication at to months follow-up. One had an anal fissure (), reported gas incontinence (), and had a discrete anal stricture (1 ; 1 ). Both of these latter patients had a sense of difficulty when emptying the bowel. However, all of these problems had disappeared at the 1-year follow-up, and no late complications were noted. DISCUSSION Treatment of hemorrhoids with is associated with severe postoperative pain. Since Doppler-guided ligation was introduced, several nonrandomized studies have reported minimal postoperative pain and early recovery.,15 There are small randomized trials comparing Dopplerguided ligation and. 10,11 In these studies, anopexy was not performed. This is the first randomized controlled trial in which Doppler-guided ligation in combination with anopexy has been compared with conventional. Despite the small size of the study, this randomized trial shows that gives less postoperative pain and better well-being in comparison with. Even if there was a significant difference in peak postoperative pain favoring, the difference between the study groups was smaller than we expected based on previously published data, and we could not verify any difference in overall pain during the first weeks between the methods.

6 Diseases of the Colon & Rectum Volume 5: (013) 9 TABLE 3. Number of patients reporting each symptom once a week or more preoperatively, at follow-up after to months, and after 1 year Preoperatively After mo After 1 y Bleeding Pain Soiling Pruritus Manual reposition = transanal hemorrhoidal dearterialization with anopexy; = open hemorrhoidectomy. p < Adding the anopexy in the present study is probably the main reason why postoperative pain after was higher than we expected. Adding a suture mucopexy to the DG-HAL technique is shown to increase postoperative discomfort significantly. 1 A No. of patients B No. of patients Grade 1 Grade Grade 3 Grade 1 Grade Grade 3 FIGURE 5. Shown is the proportion of different grades of hemorrhoids in the groups preoperatively (A) and at 1-year followup (B). Data received from examination on a straining chair. = transanal hemorrhoidal dearterialization with anopexy; = open hemorrhoidectomy. was also associated with better well-being in the early postoperative period. One reason for better well-being and less postoperative pain after might be that the patients did not experience any open anal wounds that might cause inconvenience. One might wonder whether the current results would have been same if the anal wounds after had been closed (as described by Ferguson) in this study. However, 3 randomized controlled trials have compared Ferguson with Milligan-Morgan, and they show no advantages in postoperative outcome regarding pain. It remains to be studied, whether a comparison between and with closing of the anal wounds by using the Ferguson technique would have another outcome. Even if postoperative pain was lower and well-being better in the group, there was no corresponding difference in analgesics consumption or earlier return to work. Consumption of analgesics was higher than previously described. The explanation for this might be that the patients were told to start on a maximal dose and then lower it gradually, which may have resulted in higher consumption than if the instruction had been on demand as in the study by Bursics et al. 10 Data on return to work are difficult to interpret, because, in this already small study, many patients were retired or unemployed. At 1-year follow-up in our study, only /0 patients in the group reported bleeding once a week or more in comparison with 1/0 before surgery, which is in agreement with other studies. 0 We could see a trend, however, not significant, toward more patients with remaining grade hemorrhoids after than after after 1 year. It may be argued that with regard to reducing the prolapse is inferior to where the hemorrhoidal tissue is surgically removed. At the 1-year control, patients reported that they still needed to reduce the mucosal prolapse manually. This is not in concordance with the number of only patients with remaining grade 3 hemorrhoids at examination on the straining chair and only 1 patient with remaining grade 3 hemorrhoids in the left lateral position. In 1 of the patients, the prolapse consisted of skin tags, but for the others it is likely that examination in the left lateral position underestimates the degree of prolapse.

7 90 Elmér et al: Thd/A vs Open Hemorrhoidectomy However, all grades of the hemorrhoids in this investigation were classified at a straining chair, which seems to be better related to symptoms. Examination on a straining chair may thus result in more significant remaining prolapse postoperatively in comparison with previous studies where evaluation commonly was performed in the left lateral position. Disadvantages with are the longer duration of surgery (3 vs 0 minutes compared with ) as well as the cost of the THD instrument. This should be weighted to the advantages for, as leaving no wounds and no risk of incontinence or other serious complications were reported. There are several limitations to this study. There was no blinding; we thought it would be impossible to disguise the anal wounds adequately. The clinical examination at follow-up was done by C.L. who also had performed the surgical procedures. On the other hand, data for all primary end points were obtained from patient questionnaires by a study nurse not aware of group allocation. Other limitations with our study are the small number of patients and the relatively short follow-up (1 year), and the use of a nonvalidated questionnaire, as well. The sample size is too small to conclude whether is comparable to when it comes to the reduction of symptoms and the restoration of anatomy. CONCLUSION is a safe method without serious complications and it is suitable for day-case surgery. The difference in postoperative pain in comparison with may be smaller than previously noted. There are indications that gained more satisfied patients in the short term in comparison with. References 1. Morinaga K, Hasuda K, Ikeda T. A novel therapy for internal hemorrhoids: ligation of the hemorrhoidal artery with a newly devised instrument (Moricorn) in conjunction with a Doppler flowmeter. Am J Gastroenterol. 1995;90: Sohn N, Aronoff JS, Cohen FS, Weinstein MA. Transanal hemorrhoidal dearterialization is an alternative to operative hemorrhoidectomy. Am J Surg. 001;1: Dal Monte PP, Tagariello C, Sarago M, et al. Transanal haemorrhoidal dearterialisation: nonexcisional surgery for the treatment of haemorrhoidal disease. Tech Coloproctol. 007;11: Faucheron JL, Gangner Y. Doppler-guided hemorrhoidal artery ligation for the treatment of symptomatic hemorrhoids: early and three-year follow-up results in 100 consecutive patients. Dis Colon Rectum. 00;51: Felice G, Privitera A, Ellul E, Klaumann M. Doppler-guided hemorrhoidal artery ligation: an alternative to hemorrhoidectomy. Dis Colon Rectum. 005;: Greenberg R, Karin E, Avital S, et al. First 100 cases with Doppler-guided hemorrhoidal artery ligation. Dis Colon Rectum. 00;9: Ramirez JM, Aguilella V, Elia M, et al. Doppler-guided hemorrhoidal artery ligation in the management of symptomatic hemorrhoids. Rev Esp Enferm Dig. 005;97: Infantino A, Bellomo R, Dal Monte PP, et al. Transanal haemorrhoidal artery echodoppler ligation and anopexy (THD) is effective for II and III degree haemorrhoids: a prospective multicentric study. Colorectal Dis. 010;1: Wałega P, Scheyer M, Kenig J, et al. Two-center experience in the treatment of hemorrhoidal disease using Doppler-guided hemorrhoidal artery ligation: functional results after 1-year follow-up. Surg Endosc. 00;: Bursics A, Morvay K, Kupcsulik P, Flautner L. Comparison of early and 1-year follow-up results of conventional hemorrhoidectomy and hemorrhoid artery ligation: a randomized study. Int J Colorectal Dis. 00;19: Khafagy W, El Nakeeb A, Fouda E, et al. Conventional haemorrhoidectomy, stapled haemorrhoidectomy, Doppler guided haemorrhoidectomy artery ligation; post operative pain and anorectal manometric assessment. Hepatogastroenterology. 009;5: Gerjy R, Lindhoff-Larson A, Nyström PO. Grade of prolapse and symptoms of haemorrhoids are poorly correlated: result of a classification algorithm in 70 patients. Colorectal Dis. 00;10: Gerjy R, Derwinger K, Nyström PO. Perianal local block for stapled anopexy. Dis Colon Rectum. 00;9: Nienhuijs S, de Hingh I. Conventional versus LigaSure hemorrhoidectomy for patients with symptomatic Hemorrhoids. Cochrane Database Syst Rev. 009:CD Wallis de Vries BM, van der Beek ES, de Wijkerslooth LR, et al. Treatment of grade and 3 hemorrhoids with Doppler-guided hemorrhoidal artery ligation. Dig Surg. 007;: Theodoropoulos GE, Sevrisarianos N, Papaconstantinou J, et al. Doppler-guided haemorrhoidal artery ligation, rectoanal repair, sutured haemorrhoidopexy and minimal mucocutaneous excision for grades III-IV haemorrhoids: a multicenter prospective study of safety and efficacy. Colorectal Dis. 010;1: Gençosmanoğlu R, Sad O, Koç D, Inceoğlu R. Hemorrhoidectomy: open or closed technique? A prospective, randomized clinical trial. Dis Colon Rectum. 00;5: Arbman G, Krook H, Haapaniemi S. Closed vs. open hemorrhoidectomy is there any difference? Dis Colon Rectum. 000;3: Jóhannsson HO, Påhlman L, Graf W. Randomized clinical trial of the effects on anal function of Milligan-Morgan versus Ferguson haemorrhoidectomy. Br J Surg. 00;93: Giordano P, Overton J, Madeddu F, et al. Transanal hemorrhoidal dearterialization: a systematic review. Dis Colon Rectum. 009;5: