Prospective, Randomized, Controlled Trial of Starioni vs. Ligasurei Hemorrhoidectomy for Prolapsed Hemorrhoids
Jaw-Yuan Wang, M.D.,1,2 Hsiang-Lin Tsai,
M.D.,1,3 Fang-Ming Chen, M.D.,1,2 Koung Shing Chu, M.D.,2,4 Hon-Man Chan, M.D.,1,2 Che-Jen Huang, M.D.,1,2 Jan-Sing Hsieh, M.D.1,2
Department of Surgery, Kaohsiung Medical University, Kaohsiung, Taiwan Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan 3 Department of Emergency Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan 4 Department of Anesthesia, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
PURPOSE: This study was designed to evaluate the efficacy and outcome of the Starioni and Ligasurei vessel sealing systems for sutureless hemorrhoidectomy. METHODS: Sixtyfour patients with Grades III and IV hemorrhoids were randomized into two groups: 1) Starioni hemorrhoidectomy (32 patients), and 2) Ligasurei hemorrhoidectomy (32 patients). The patient demographics, operative details, numbers of parenteral analgesic injections, postoperative pain scores (assessed by an independent assessor), operating time, intraoperative blood loss, hospital stay, early and delayed complications, and time off from work or normal activity were recorded. The patients were regularly followed-up at 1, 2, 4, 6, 8, and 12 weeks after surgery. RESULTS: The mean blood loss, mean operating time, duration of hospital stay, and time off from work or normal activity were not significantly different between the two methods (all P > 0.05), except for a lower pain score (P = 0.032) and reduced numbers of parenteral analgesic injections (P < 0.001) in Starioni hemorrhoidectomy. In addition, there were no differences in the early and delayed postoperative complications between the two methods (all P > 0.05). Unfortunately, two patients with symptomatic anal stenosis requiring treatment were encountered by
Ligasurei hemorrhoidectomy, but none by Starioni hemorrhoidectomy. CONCLUSIONS: Starioni hemorrhoidectomy with submucosal dissection is a safe and effective procedure, comparable to Ligasurei hemorrhoidectomy. Patients derive a short-term benefit of less pain and reduced parenteral analgesic use by Starioni hemorrhoidectomy. The superiority of no cases complicated with symptomatic anal stenosis requiring treatment by Starioni hemorrhoidectomy seems to offer a better therapeutic alternative for prolapsed hemorrhoids. [Key words: Hemorrhoid; Starioni; Ligasurei; Submucosal dissection]
Correspondence to: Jan-Sing Hsieh, M.D., Department of Surgery, Kaohsiung Medical University Hospital, 100 Tzyou 1st Road, Kaohsiung, 807, Taiwan, e-mail: email@example.com Dis Colon Rectum 2007; 50: 1–6 DOI: 10.1007/s10350-007-0260-3 * The American Society of Colon and Rectal Surgeons
emorrhoidectomy is superior to any proposed conservative procedure, including rubber band ligation, sclerotherapy, photocoagulation, and cryotherapy for treating symptomatic Grades III and IV hemorrhoids.1 Unfortunately, it is usually associated with significant postoperative complications, including pain, bleeding, and anal stricture, which can result in a protracted period of convalescence.2 Therefore, this has stimulated continuing efforts to develop new techniques and modifications that promise a less painful course and faster recovery. Recent advances in instrumental technology, including the bipolar electrothermal device,3 ultrasonic scalpel,4 and circular stapler,5 are gaining popularity as effective alternatives in hemorrhoidectomy. Of
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these instruments, theoretically, the Ligasurei vessel sealing system (Valleylab, Boulder, CO) is an ideal instrument for hemorrhoidectomy because its limited tissue injury may reduce wound sepsis, facilitate wound healing, and decrease postoperative pain. Several randomized trials have been performed to compare Ligasurei hemorrhoidectomy with conventional hemorrhoidectomy,3,8–12 and it is suggested that Ligasurei hemorrhoidectomy is a safe and effective method to improve surgical outcomes. Likewise, we have demonstrated the Ligasurei vessel sealing system is an ideal instrument for hemorrhoidectomy, because it enables short-term benefit of reduced intraoperative blood loss, operative time, and postoperative pain, as well as earlier resumption of work or normal activity.6 However, at three-month follow-up of these 42 patients treated by Ligasurei hemorrhoidectomy with submucosal dissection, two patients (6.3 percent) developed symptomatic anal stenosis requiring anal dilation with St. Mark_s dilators. Significant heat production generated by the larger surface area of jaws leading to a scalding effect may be responsible for this complication.7,13 Another novel vessel sealing system, Starioni TLS2 (Starion Instruments Corp., Saratoga, CA), uses the Btissue welding technology^ to simultaneously fuse vessels and tissue structures closed and is designed for a number of surgical applications, including gastric bypass, Nissen fundoplication, and hemorrhoidectomy procedures. Because tissuewelding technology uses minimum energy as a mode of operation at temperatures < 100-C, it thereby produces less heat and minimizes collateral tissue damage for improved patient outcomes. Up to the present, no information about Starioni surgical devices for the management of prolapsed hemorrhoids has been reported. In this randomized, controlled study, we proposed Starioni hemorrhoidectomy with submucosal dissection to ensure the intact underlying sphincter and complete removal of hemorrhoid bundles. The operative outcomes between Starioni and Ligasurei hemorrhoidectomy are compared to determine the efficacy and safety between the two vessel sealing devices.
Medical University Hospital, between December 2005 and June 2006. This study has been approved by the Institutional Review Board of Kaohsiung Medical University Hospital and is not supported by any commercial company. Written, informed consent was obtained from all of the subjects and/or guardians after full explanation of the procedure. The exclusion criteria included patients taking anticoagulants, with hematologic disorder, with concomitant anal disease, or previous history of anorectal surgery. The recruited patients were randomly allocated to undergo a Starioni hemorrhoidectomy with submucosal dissection (32 patients) or Ligasurei hemorrhoidectomy with submucosal dissection (32 patients). The submucosal dissection technique was used in both arms, and the only difference in the technique was the energy source. The operative procedures for hemorrhoidectomy were standardized in each case by the same team of surgeons. Randomization was performed at the time of anesthesia by drawing sealed envelopes to receive Starioni or Ligasurei hemorrhoidectomy. The operation was performed under general or epidural anesthesia at the discretion of the anesthetist. The patients were placed in the prone jackknife position and a Ferguson retractor was used to expose the hemorrhoids. Starioni hemorrhoidectomy with submucosal dissection was performed initially with a skin incision at the junction of the hemorrhoid and the flat perianal skin by a scalpel, followed by the dissection of the hemorrhoid bundles off the underlying sphincter (Fig. 1). Starioni handset was applied to the dissected hemorrhoids to the pedicles, taking care to avoid incorporating the underlying
PATIENTS AND METHODS
This prospective study included 64 consecutive patients with symptomatic Grade III or IV hemorrhoid operated at the Department of Surgery, Kaohsiung
Figure 1. Dissection of the hemorrhoidal complex off the underlying sphincters using a mosquito clamp.
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Figure 2. Starioni handset was applied beneath dissected hemorrhoids.
Figure 4. Completed sutureless hemorrhoidectomy.
sphincter, and the device was activated to seal mucosal edges on each side (Fig. 2). Finally, the hemorrhoidal pedicle was sealed and divided by Starioni handset (Fig. 3). Figure 4 depicts the result of complete hemorrhoidectomy. Ligasurei hemorrhoidectomy also was performed according to our previous description. 6 In both Starioni and Ligasurei groups, hemostasis was ensured and a hemostatic sponge was inserted into the anal canal. For postoperative pain relief, oral acetaminophen (500 mg) was prescribed for all patients at the dose of one tablet, four times per day. Additional parenteral analgesics would be administrated when patients complained of pain intolerance. The independent assessor evaluated the pain score by means of the visual analog score (0–10) at 24 hours postoperatively. The patient demographics, duration
of symptoms, operative details, operating time, intraoperative blood loss, and hospital stay were documented. Follow-up was performed at 1, 2, 4, 6, 8, and 12 weeks to detect postoperative complications and time off work or normal activity in all 64 patients by an independent blind assessor. Initial power calculation suggested that a minimum of 30 patients would be required to achieve statistical significance in postoperative pain with a power of 80 percent at the 5 percent significance level. All data were analyzed by using the Statistical Package for the Social Sciences Version 11.5 software (SPSS Inc., Chicago, IL). Results were expressed as means T standard deviations. The two-sided Pearson chisquared test and Student_s t-test were used to compare the variables between the two groups. P < 0.05 was considered statistically significant.
The characteristics of 64 symptomatic patients with Grade III and IV hemorrhoids are summarized in Table 1. There were 15 males and 17 females treated by Starioni hemorrhoidectomy, and 16 males and 16 females treated by Ligasurei hemorrhoidectomy (P = 0.802). The mean age was 46.9 T 2.4 and 47.8 T 2.3 years for the Starioni and Ligasurei hemorrhoidectomies, respectively (P = 0.638). In addition, there was no statistical difference in the duration of symptoms (P = 0.857) and the severity of hemorrhoids (P = 0.777) between the two groups. Table 2 shows the operative details and outcomes between the two groups. The numbers of hemorrhoids resected, mean operating time, mean intraoperative blood loss, hospital study, and return to normal activity were not significantly different be-
Figure 3. Complete excision and sealing of the hemorrhoidal pedicle by Starioni device.
WANG ET AL Table 1. Characteristics of Patients Randomized to Group 1 (Starioni Hemorrhoidectomy) or Group 2 (Ligasurei Hemorrhoidectomy) Characteristics Mean age (yr) (range) Male/female ratio Symptoms (mo) <12 12–24 >24 Grade III IV Group 1 (n = 32) 46.9 T 2.4 (21–74) 15/17 Group 2 (n = 32) 47.8 T 2.3 (23–75) 16/16 P Value 0.638 0.802
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4 13 15 24 8
3 12 17 23 9
tween the two groups (all P > 0.05). However, lower pain scores (P = 0.032) and numbers of parenteral analgesic injections (P < 0.001) during admission were observed in the Starioni hemorrhoidectomy than in the Ligasurei hemorrhoidectomy. Regarding early postoperative complications, two (6.3 percent), one (3.1 percent), and one (3.1 percent) patient developed constipation, urine retention, and hemorrhage respectively, in the Starioni hemorrhoidectomy, whereas two (6.3 percent), two (6.3 percent), and one (3.1 percent) patient developed the corresponding complications in the Ligasurei hemorrhoidectomy (all P > 0.05). The incidence of postoperative hemorrhage was the same
in each group (3.1 percent), which happened to one patient with underlying chronic renal failure receiving hemodialysis and to another one with underlying liver cirrhosis. Both patients hemorrhaged two weeks after surgery. The incidence of delayed postoperative complications, such as poor wound healing (not completely healed at 4 weeks postoperatively) and symptomatic anal stenosis (improvement of anal stenosis by cathartics, anal dilation, or surgical intervention is mandatory) did not show any significant difference between the two groups (both P > 0.05). Complete wound healing was achieved in three patients who were found to have poor wound healing at the fourweek follow-up, after six weeks in both groups. Unfortunately, two patients (6.25 percent) developed subsequent anal stenosis requiring anal dilation at the outpatient department in the Ligasurei hemorrhoidectomy, whereas no symptomatic anal stenotic patients were found in the Starioni hemorrhoidectomy at the three-month follow-up. Finally, the return to work or normal activity was not considerably different between Starioni hemorrhoidectomy (7.4 T 0.3 days) and Ligasurei hemorrhoidectomy (7.6 T 0.3 days; P = 0.787).
Hemorrhoidectomy has been well established as the most effective and definitive treatment of choice for prolapsed hemorrhoids. However, although it is
Table 2. Operative Details and Outcomes of Patients Randomized to Group 1 (Starioni Hemorrhoidectomy) or Group 2 (Ligasurei Hemorrhoidectomy) Group 1 (n = 32) No. of hemorrhoid resected 2 3 4 Mean blood loss (ml) Mean operating time (min) Pain score (0–10) (24 hr) Parenteral analgesics use Hospital stay (days) Postoperative complications Constipation Urinary retention Hemorrhage Poor wound healing (at 4 wk) Anal stenosis (at 12 wk) Return to work or normal activity (days) 3 14 15 2.1 T 0.3 12.2 T 0.4 4.2 T 0.1 6 2.2 T 0.1 2 1 1 1 0 7.4 T 0.3 Group 2 (n = 32) 2 16 14 1.8 T 0.3 11.3 T 0.4 5.1 T 0.2 11 2.4 T 0.1 2 2 1 2 2 7.6 T 0.3 P Value 0.832 0.093 0.464 0.032 < 0.001 0.059 1 0.554 1 0.554 0.151 0.787
Data are numbers or means T standard errors unless otherwise indicated.
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considered a minor procedure, the postoperative course is protracted, and the postoperative complications are not negligible. The resulting pain-related complications after conventional hemorrhoidectomy often are the major factors that prolong hospital stay and delayed recovery. Recently various new treatment modalities have been developed with the goal of overcoming postoperative pain, such as Harmonic scalpeli, Ligasurei, and Starioni sealing devices. The Starioni Thermal Welding system, a new type of surgical instrument, has been developed, which uses thermal energy and pressure to simultaneously coagulate, as well as divide blood vessels and other tissue. The device offers the surgeon an alternative to existing technologies, including the bipolar and ultrasonic coagulating and sealing instruments, in the management of prolapsed hemorrhoids. Recently we have demonstrated that Ligasurei hemorrhoidectomy with submucosal dissection is a fast, safe, and excellent surgical modality for achieving bloodless dissection of the hemorrhoidal cushions with a limited complication rate.6 Compared with Ferguson hemorrhoidectomy, the Ligasurei method of dissection prominently reduces postoperative pain and numbers of parenteral analgesic injections, which illustrates that the minimal collateral thermal spread, limited tissue charring, and absence of sutures might lead to less postoperative pain. Consequently, the Ligasurei system would facilitate earlier hospital discharge and return to normal work or activities.8–13 In addition, Harmonic Scalpeli (UltraCision\ 10-mm Coagulating Shears, Ethicon Endo-Surgery, Inc., Cincinnati, OH) also is a new tissue sealing instrument that makes use of a different energy source, of which has been reported that Harmonic Scalpeli is superior to bipolar scissors because of less postoperative pain.14 Kwok et al. also have demonstrated that Ligasurei hemorrhoidectomy reduces the postoperative pain and operating time compared with the Harmonic scalpel hemorrhoidectomy.15 In the current investigation, we have demonstrated that Starioni hemorrhoidectomy has the short-term benefits of less postoperative pain and parenteral analgesic requirement than Ligasurei hemorrhoidectomy. However, the pain during the first 24 hours after surgery often is the most critical point, because it is during that time period that severe pain may exacerbate urinary retention, especially in male patients. The same advantages of shorter operating time and little blood loss were detected in both methods. In both
methods, with the concomitant use of submucosal dissection, the hemorrhoidal plexuses can be readily elevated off the underlying anal sphincter, allowing safe application of the diathermy forceps and no clinical sphincter injury. Consequently, with the preservation of sphincters, no flatus or stool incontinence was noted in both groups. By Ligasurei hemorrhoidectomy symptomatic anal stenosis was noted, which is similar to observation from Ramcharan and Hunt,7 whereas no anal stenosis was discovered by Starioni hemorrhoidectomy. This may be entirely to the result of minimal thermal spread to collateral tissue by Starion_s thermal welding technology, leading to no charring of tissue. The early and delayed complication rates of both methods are similar, and no serious complications were observed. After conservative management, all of the patients recovered uneventfully without subsequent surgical intervention. One of 32 patients (3.1 percent) in each group developed postoperative hemorrhage: one patient with an underlying disease of uremia, and the other with an underlying disease of liver cirrhosis. Poor wound healing with the coexisting medical illness may be the major reason for this complication. Therefore, for treating these patients, a longer close-up observation period is highly recommended. As usual, stapled hemorrhoidectomy is suggested to be used primarily in patients with third-degree hemorrhoids. Indeed, circular stapling devices are unsatisfactory in dealing with external hemorrhoidal components and skin tags.16 In practice, Ligasurei hemorrhoidectomy is now used increasingly for more severe hemorrhoidal diseases, such as Grade IV piles, rather than considering a more radical operation.17,18 Alternatively, from our preliminary results, using Starioni hemorrhoidectomy with submucosal dissection, concomitant external hemorrhoid components and skin tags can be dealt with, and the complete removal of the hemorrhoid tissues can be ensured while keeping the underlying sphincter intact. No symptomatic anal stenosis at a three-month follow-up, despite no statically significant difference, is an attractive reason for surgeons to choose Starioni devices among various tissue sealing instruments.
Both methods were found to be surprisingly equivalent in all major aspects analyzed. Starioni
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hemorrhoidectomy with submucosal dissection can provide a safe, fast, bloodless, and low-morbidity surgical alternative to hemorrhoidal surgery. However, long-term follow-up with a larger series is warranted for its definite role in treating this disease.
1. MacRae HM, McLeod RS. Comparison of hemorrhoidal treatment modalities. A meta-analysis. Dis Colon Rectum 1995;38:687– 94. 2. Ho YH, Seow-Choen F, Tan M, Leong AF. Randomized controlled trial of open and closed haemorrhoidectomy. Br J Surg 1997;84:1729 – 30. 3. Sayfan J, Becker A, Koltun L. Sutureless closed hemorrhoidectomy: a new technique. Ann Surg 2001;234:21 – 4. 4. Rowsell M, Bello M, Hemingway DM. Circumferential mucosectomy (stapled haemorrhoidectomy) versus conventional haemorrhoidectomy: randomised controlled trial. Lancet 2000;355:779 – 81. 5. Armstrong DN, Ambroze WL, Schertzer ME, Orangio GR. Harmonic Scalpel vs. electrocautery hemorrhoidectomy: a prospective evaluation. Dis Colon Rectum 2001;44:558– 64. 6. Wang JY, Lu CY, Tsai HL, et al. Randomized controlled trial of Ligasure with submucosal dissection versus Ferguson hemorrhoidectomy for prolapsed hemorrhoids. World J Surg 2006;30:462 – 6. 7. Ramcharan KS, Hunt TM. Anal stenosis after Ligasurei hemorrhoidectomy. Dis Colon Rectum 2005;48:1670 – 1. 8. Palazzo FF, Francis DL, Clifton MA. Randomized clinical trial of Ligasurei versus open haemorrhoidectomy. Br J Surg 2002;89:154 – 7.
9. Jayne DG, Botterill I, Ambrose NS, Brennan TG, Guillou PJ, O_Riordain DS. Randomized clinical trial of Ligasurei versus conventional diathermy for daycase haemorrhoidectomy. Br J Surg 2002;89:428 – 32. 10. Thorbeck CV, Montes MF. Haemorrhoidectomy: randomised controlled clinical trial of Ligasure\ compared with Milligan-Morgan operation. Eur J Surg 2002;168:482 – 4. 11. Chung YC, Wu HJ. Clinical experience of sutureless closed hemorrhoidectomy with Ligasurei. Dis Colon Rectum 2003;46:87 – 92. 12. Franklin EJ, Seetharam S, Lowney J, Horgan PG. Randomized clinical trial of Ligasurei vs. conventional diathermy in hemorrhoidectomy. Dis Colon Rectum 2003;46:1380 – 3. 13. Gravante G, Venditti D. Postoperative anal stenoses with Ligasure hemorrhoidectomy. World J Surg 2007;31:245. 14. Chung CC, Ha JP, Tai YP, Tsang WW, Li MK. Doubleblind, randomized trial comparing Harmonic Scalpel hemorrhoidectomy, bipolar scissors hemorrhoidectomy, and scissors excision: ligation technique. Dis Colon Rectum 2002;45:789 – 94. 15. Kwok SY, Chung CC, Tsui KK, Li MK. A double-blind, randomized trial comparing Ligasurei and Harmonic scalpeli hemorrhoidectomy. Dis Colon Rectum 2005;48:344 – 8. 16. Engel AF, Eijsbouts QA. Haemorrhoidectomy: painful choice. Lancet 2000;355:2253 – 4. 17. Basdanis G, Papadopoulos VN, Michalopoulos A, Apostolidis S, Harlaffis N. Randomized clinical trial of stapled hemorrhoidectomy vs open with Ligasure for prolapsed piles. Surg Endosc 2005;19:235 – 9. 18. Kraemer M, Parulava T, Roblick M, Duschka L, MullerLobeck H. Prospective, randomized study: Proximate\ PPH stapler vs. Ligasurei for hemorrhoidal surgery. Dis Colon Rectum 2005;48:1517 – 22.