ORIGINAL ARTICLE ANZJSurg.com
Ligasure, Harmonic Scalpel versus conventional diathermy in excisional haemorrhoidectomy: a randomized controlled trial Ahmed Talha,* Samer Bessa† and Moataza Abdel Wahab‡ *Department of Surgery, Medical Research Institute, Alexandria University, Alexandria, Egypt †Department of Surgery, Faculty of Medicine, Alexandria University, Alexandria, Egypt and ‡Department of Biostatistics, High Institute of Public Health, Alexandria University, Alexandria, Egypt
Key words diathermy, haemorrhoidectomy, haemorrhoids, Harmonic Scalpel, Ligasure. Correspondence Dr Ahmed Talha, Department of Surgery, Medical Research Institute, Alexandria University, 165 Horreya Avenue, Hadara, Alexandria 21561, Egypt. Email: [email protected] A. Talha MD, MRCS; S. Bessa MD; M. Abdel Wahab PhD. Accepted for publication 28 July 2014. doi: 10.1111/ans.12838
Abstract Background: This study was designed to compare the surgical outcomes of haemorrhoidectomy performed by the Ligasure, Harmonic Scalpel with that performed by the conventional diathermy. Methods: A total of 180 patients were randomized to Ligasure, Harmonic Scalpel and diathermy haemorrhoidectomy, 60 patients for each group. The operative time, postoperative pain scores, parenteral analgesic requirements in the first 24 h, postoperative complications and wound healing rates were documented. Results: The median operative time was 8 min (range, 7–18) for the Ligasure and Harmonic Scalpel groups and 18 min (range, 15–21) for the diathermy group (P < 0.001). Throughout the first post-operative week, the daily median pain score was lower in the Ligasure and Harmonic Scalpel groups than in the diathermy group (P < 0.001). The median number of analgesic ampoules during the first 24 h postoperatively was lower in the Ligasure and Harmonic Scalpel groups (P < 0.001). There was no statistically significant difference in the incidence of post-operative complications. At 6 weeks post-operation, more patients in the Ligasure and Harmonic Scalpel groups had complete healing of wounds (P = 0 < 0.001). Conclusion: Ligasure and Harmonic Scalpel provide a superior alternative to conventional diathermy in haemorrhoidectomy with no difference between them in reducing the operative time, post-operative pain, analgesic requirements during the first 24 h and time to complete healing of wounds.
Introduction Haemorrhoidectomy is a known painful procedure and this reputation, in combination with the high prevalence of haemorrhoidal disease, has generated much interest in outpatient treatments of haemorrhoids.1 Rubber-band ligation, injection sclerotherapy, infrared photocoagulation and cryotherapy have been used with some success, but the results are inferior to surgery.1–4 Surgical treatment, reserved for patients with prolapsing haemorrhoids, consists of excision and ligation of the ‘pile’ with or without closure of the defect. Milligan–Morgan haemorrhoidectomy, as described in 1937,5 remains the most popular technique. Considerable research over the last two decades has concentrated on reducing pain following these surgical procedures. The research was mainly directed towards three areas: analgesic delivery during the post-operative © 2014 Royal Australasian College of Surgeons
period, modification of the surgical technique and the use of a variety of surgical instruments in the hope of decreasing post-operative pain.1,3 Modifications include open, semi-open,1,3 closed incisions,1 routine performance of lateral internal sphincterotomy6 and the use of stapling devices as advocated by Longo and colleagues.7,8 Among these modifications are the use of diathermy pedicle coagulation,9 the Harmonic Scalpel (Ethicon, Cincinnati, OH, USA)9 and the Ligasure System (Valleylab, Boulder, CO, USA).10–12 Several studies have suggested that both the Harmonic Scalpel and the Ligasure System were associated with less postoperative pain compared with the conventional diathermy.10–24 Motivated by these reports, this study was designed to compare the surgical outcomes of haemorrhoidectomy performed by Ligasure, Harmonic Scalpel with that performed by conventional diathermy. ANZ J Surg •• (2014) ••–••
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Talha et al.
Fig. 1. Trial flowsheet showing progress through the phases of the trial. Total number of patients considered for study participation n = 240
Eligable n = 200
Randomized to Harmonic ScalpelTM n = 66
Refused to continue n=2
Lost followup n=4
Continued till the end n = 60
Randomized to LigasureTM n = 67
Refused to continue n=0
Lost followup n=7 Continued till the end n = 60
Not eligable n = 40 Randomized to diathermy n = 67
Refused to continue n=1
- Previous anal surgery n = 12 - Concomittent anal pathology requiring surgery n = 18 - Refused to participate n = 10
Lost followup n=6 Continued till the end n = 60
Study design and randomization This study was approved by the Ethics Committee of the Faculty of Medicine and Medical Research Institute, University of Alexandria. Patients who fulfilled the inclusion and exclusion criteria and completed the follow-up for 1 year were included in the study; they were 180 patients from March 2010 through October 2012. Eligible patients were randomly assigned using sealed opaque envelopes containing computer-generated random numbers into one of the three groups: the Ligasure, Harmonic Scalpel or diathermy haemorrhoidectomy (Fig. 1). A written informed consent was obtained from all participants. Inclusion criteria included symptomatic grades III or IV haemorrhoids (fresh rectal bleeding, itching, anal discomfort or prolapse). Exclusion criteria included previous anal surgery, any degree of focal incontinence, concomitant anal conditions requiring surgical treatment at the time of haemorrhoidectomy, for example fissure or fistula.
Procedures All operations were performed under a standardized spinal anaesthesia with the patient in the prone jackknife position. A standardized, three-quadrant haemorrhoidectomy was performed in all patients. The medium-sized Hill Ferguson retractor (CS Surgical, Inc., Los Angeles, CA, USA) was used in all procedures. Each haemorrhoidal cushion was managed as follows. For Ligasure haemorrhoidectomy, three applications of the Axs handle were required to excise each haemorrhoidal cushion. The first application included the perianal skin, including the external component of the cushion; the second included the part overlying the internal sphincter; and the third included the pedicle 0.5 cm above the dentate line. After each application, completion of coagulation was signalled by the characteristic two-tone sound and cutting along the middle of the line of the coagulum until complete excision of the cushion was achieved. For Harmonic Scalpel haemorrhoidectomy, we used the ‘scissor’ configuration (Coagulating Shears Model, Ethicon). After each application, completion of coagulation and cut along the middle of the line of the coagulum until complete excision of the haemorrhoidal cushion was achieved.
For diathermy haemorrhoidectomy, a V-shaped incision was made in the perianal skin distal to the cushion to include the external component then, dissecting the haemorrhoidal tissue from the internal sphincter. The pedicle was transfixed 0.5 cm above the dentate line using Vicryl 3/0 sutures (Ethicon, Johnson & Johnson International, Sint-Stevens-Woluwe, Belgium). Haemorrhoidal tissue was excised and the wound was left open.
Post-operative course and outcome measurement The operative time was calculated by an independent observer. Pain was assessed post-operatively using a visual analogue scale from 1 to 10. Patients were asked to score their pain in the morning of the first seven post-operative days. Daily and weekly median scores were calculated for each group. Patients were given diclofenac potassium 75 mg intra-muscular injections as required, and the number of ampoules required during the first 24 h post-operatively was recorded. Early post-operative complications, for example haemorrhage and urine retention, were recorded. Patients were kept in the hospital overnight and were discharged in the morning of the first post-operative day. Discharge medication was standardized and included diclofenac potassium tablets 50 mg t.d.s, metronidazole 400 mg t.d.s., Lactulose 20 mL b.i.d and glyceryl trinitrate cream 0.2% topically t.d.s. Follow-up was performed by two independent assessors who were blinded to the operative technique used and assessing patients’ outcome. It was performed by inspection of the wound in the outpatient clinic on a weekly basis for the first six weeks and then at 3, 6 and 12 post-operative months assessing wound healing, symptoms control and complications.
Statistical analysis Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) version 16 software (SPSS, Inc., Chicago, IL, USA). Significance was set at a P-value < 0.05. The chi-squared test was used to compare characteristics of the sample, namely gender, grade of haemorrhoids and duration of disease. One-way analysis of variance (ANOVA) was used to compare the three groups © 2014 Royal Australasian College of Surgeons
Ligasure, harmonic & diathermy in haemorrhoidectomy
3
regards their age, sex, duration of complaint and grade of haemorrhoids (Table 1). The median operative time was significantly higher in diathermy than Ligasure and Harmonic Scalpel groups (Table 2). In the Ligasure and Harmonic Scalpel groups the dissection was entirely bloodless in all patients. Throughout the first seven postoperative days, the daily median pain score was lower in the Ligasure and Harmonic Scalpel groups than in diathermy group (P < 0.0001; Fig. 2) where there is a significant difference between groups and among the same group along first 7 days (Fig. 2). The median weekly pain score was significantly higher in diathermy than the other two groups (Table 2). The median number of analgesic ampoules required during the first 24 h post-operatively was 2 (range, 0–3) in the Ligasure and Harmonic Scalpel and 3 (range, 1–3) in the diathermy (P < 0.001; Table 2). Post-operative complications were encountered in two patients (3.3%) in each of the Ligasure and Harmonic Scalpel groups, and in seven patients (11.7%) in the diathermy group with the difference being statistically insignificant. Urine retention requiring temporary catheterization was encountered in two patients (3.3%) in the Ligasure and Harmonic Scalpel groups, and in five patients (8.33%) in the diathermy group with the difference being statistically insignificant. None of the patients in the Ligasure and Harmonic Scalpel groups developed reactionary haemorrhage compared with two patients (3.33%) in the diathermy group with the difference being statistically insignificant. In these two patients, reactionary
as regards their age. It is worth mentioning that all patients suffered no pain preoperatively (baseline). Significance in pain score change was detected using repeated measures ANOVA (with Bonferroni correction), including type of intervention and grade of haemorrhoids as potential independent factors that may affect pain score and its change along the 7 days post-operation. Kruskal–Wallis test was used to compare median operative time, average week pain score, analgesic requirements (ampoules) and hospital stay among the three procedures. Reductions in post-operative pain of 50% and >30% in the operative time were clinically relevant, and these were chosen as parameters with which to calculate the sample size.14 For the results obtained in the current study, at alpha level 0.05, the power of detection of difference between Ligasure and Harmonic Scalpel groups (60 patients each) versus diathermy group (60 patients) was 100%, yet the power to detect statistical difference in pain scores between Ligasure and Harmonic Scalpel groups was low and it needs a much higher sample size to detect statistically significant difference between these groups.
Results The data revealed 180 patients with complete follow-up for at least 1 year (Fig. 1). There were 118 men (65.6%) and 62 women (34.4%). There was no significant difference between the three groups as
Table 1 Characteristics of study sample by type of operation Type of operation Ligasure group Number (n = 60) Age (years) mean ± SD Gender Male Female Duration (months) >12 12–24 >24 Grade III IV
Harmonic Scalpel group %
Number (n = 60)
33 ± 13
%
Test of significance
Diathermy group Number (n = 60)
33 ± 12
%
Total Number (n = 180)
32 ± 11
%
33 ± 12
F = 0.172, P = 0.842
39 21
65.0 35.0
37 23
61.7 38.3
42 18
70.0 30.0
118 62
65.6 34.4
χ2 = 0.935 P = 0.627
17 21 22
28.3 35.0 36.7
17 21 22
28.3 35.0 36.7
11 22 27
18.3 36.7 45.0
45 64 71
25.0 35.6 39.4
χ2 = 2.335 P = 0.674
24 36
40.0 60.0
24 36
40.0 60.0
21 39
35.0 65.0
69 111
38.3 61.7
χ2 = 0.423 P = 0.809
SD, standard deviation.
Table 2 Type of operation, operative and post-operative parameters Type of operation Ligasure group Number (n = 60)
Operative time Average weekly pain score Analgesic requirements (ampoules) Hospital stay Post-operative complications Urine retention Bleeding
%
(7–18), 8.0 (2.57–6.86), 4.5 (0–3), 2.0 (1–1), 1.0 2 0
© 2014 Royal Australasian College of Surgeons
3.33 0.00
Harmonic Scalpel group Number (n = 60)
%
(min–max), median (7–18), 8.0 (2.57–6.86), 4.43 (0–3), 2.0 (1–1), 1.0 2 0
3.33 0.00
Test of significance
Diathermy group Number (n = 60)
%
Total Number (n = 180)
Kruskal–Wallis test χ2 = 119.7, P = 0.0001 2 χ = 114.1, P = 0.0001 χ2 = 95.2, P = 0.0001 χ2 = 4.02, P = 0.134
(15–21), 18.0 (6–8.29), 7.14 (1–3), 3.0 (1–2 (2 cases)), 1.0 5 2
8.33 3.33
%
9 2
5.00 1.11
χ2 = 2.11, P = 0.349 χ2 = 4.04, P = 0.132
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Talha et al.
Estimated marginal means of pain score 8
Pain score
7 6 5 4 3 Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
Fig. 2. Estimated mean pain score along 7 days post-operative by type of intervention. ( ) Ligasure group; ( ) Harmonic Scalpel group; ( ) diathermy group.
haemorrhage developed the night of the operation necessitating packing under anaesthesia. In the Ligasure group, the hospital stay was 1 day for all patients. In the diathermy group, it was 1 day in 58 patients (96.67%) and 2 days in the two patients (3.33%) who developed reactionary haemorrhage. At the end of the first postoperative week, it was observed that all wounds in the Ligasure and Harmonic Scalpel groups were open and were not closed as was the case at the end of the operation. At the end of the sixth post-operative week, complete healing of all wounds was observed in all patients in the Ligasure and Harmonic Scalpel groups (100%) compared with 46 patients (76.67%) in the diathermy group. This difference in the healing rate at 6 weeks post-operatively was statistically significant (P = 0.0001). At the end of the third month, all wounds were healed, all patients were free of symptoms, also faecal incontinence scores were as preoperative values in the three groups using a validated continence scoring system.19 At the end of the 6 and 12 post-operative months, neither recurrences nor anal stenosis were detected in any of the three groups.
Discussion The main finding of the present study was that the use of both the Harmonic Scalpel and the Ligasure system was associated with less post-operative pain compared with the use of diathermy. Harmonic Scalpel has been used in haemorrhoidectomy and is compared with the Ligasure in a randomized controlled trial done by Kwok et al.,21 which showed the post-operative pain score and postoperative oral analgesic requirement and the operative time were significantly less in the Ligasure group. The use of an ultrasonic device was associated with more post-operative pain. Such results are not in agreement with those of the present study. The results of the present study showed no significant difference between them in terms of post-operative pain, analgesic requirements and the operative time. This discrepancy could be explained by a relatively small number of patients included in their study to build up a more comprehensive conclusion. In the present study, we standardized many variables to avoid variation in the results of pain assessment by excluding patients with other ano-rectal pathology and patients with neurological defects or
chronic pain syndromes and those currently taking narcotic analgesics. Regarding the surgical technique, we used standard spinal anaesthesia and the open method to avoid the debate around the effect of using the closed technique on post-operative pain perception. This study clearly demonstrates the superior pain control profile of Harmonic Scalpel in comparison with diathermy haemorrhoidectomy and also the less need for analgesics. Similar results were obtained by Armstrong et al.,9 but they used both open and closed techniques, which is a potential flaw in their study, although it did not affect their final conclusion. Chung et al.22 reported that Harmonic Scalpel is superior to bipolar scissors haemorrhoidectomy because it is associated with less postoperative pain and hence better patient satisfaction. However, these observed benefits were small and the time off work to regain normal activity remained similar. But Tan et al.23 reported that Harmonic Scalpel is nearly comparable with diathermy haemorrhoidectomy in terms of post-operative pain and complications. In our study, this was not the case, as there was a significant reduction in post-operative pain and less analgesic consumption in Harmonic Scalpel compared with diathermy haemorrhoidectomy. Our results are comparable with those of Ivanov et al.,24 Ozer et al.25 and Abo-Hashem et al.26 who reported that Harmonic Scalpel haemorrhoidectomy has a significant reduction in post-operative pain scoring, induced better haemostasis and less analgesic consumption. In the present study, a significant wound healing difference was found at 6 weeks post-operatively between Harmonic Scalpel and diathermy where complete wound healing was noticed in all patients in the Harmonic Scalpel group (100%) compared with (76.67%) in the diathermy group. Similar results have been presented by AboHashem et al.26 who found a significant fast wound healing in Harmonic Scalpel haemorrhoidectomy. This higher rate of wound healing at 6 weeks post-operatively could be explained by minimal tissue trauma, minimal charring, no tissue necrosis and less local oedema in the surrounding tissues.26 Our study has revealed significant differences in the surgical outcomes of haemorrhoidectomy performed by the Ligasure and that performed by the conventional diathermy in terms of operative time, post-operative pain and analgesic requirements during the first 24 h after surgery, and the rate of complete wound healing at 6 weeks post-operatively. In accordance with all earlier studies comparing Ligasure with diathermy in haemorrhoidectomy, the median operative time for Ligasure was significantly shorter than diathermy haemorrhoidectomy.10,12–17,27 Similarly, earlier studies have confirmed the absolute bloodlessness of Ligasure haemorrhoidectomy and so did the present study.10,12–17,27 This characteristic was believed to be a significant advantage of this technique for two reasons: (i) the operative time was shortened because no time was required to secure haemostasis or to ligate the pedicles; and (ii) the perfect haemostasis produced by Ligasure has made the operative technique simpler, easier and quicker. Jayne et al.,12 Palazzo et al.14 and Milito et al.16 found that although Ligasure haemorrhoidectomy was not associated with a significant reduction in post-operative pain, it was associated with a © 2014 Royal Australasian College of Surgeons
Ligasure, harmonic & diathermy in haemorrhoidectomy
significant reduction in the median number of analgesic consumption in the post-operative course. Others10,17 found that Ligasure haemorrhoidectomy was associated with significant less postoperative pain and parenteral analgesic requirements compared with Ferguson haemorrhoidectomy. Franklin et al.15 and Thorbeck and Montes13 found that Ligasure haemorrhoidectomy was associated with a significant reduction in both post-operative pain and analgesic requirements in the immediate post-operative period and 24 h later. In the present study, Ligasure haemorrhoidectomy was found to be associated with a significant reduction in both post-operative pain in the first post-operative week and analgesic requirements during the first 24 h post-operatively. In the present study, complete healing of all wounds was found in all patients in the Ligasure group (100%) compared with (76.67%) in the diathermy group at 6 weeks post-operatively, which is statistically significant. Similar results have been obtained by Sayfan et al.,27 Milito et al.,16 and Thorbeck and Montes13 who found a significant faster wound healing in Ligasure haemorrhoidectomy. The minimal tissue trauma produced by the Ligasure, minimal charring, no tissue necrosis and less oedema in the surrounding tissue is proposed to be responsible for this higher rate of wound healing at 6 weeks post-operatively.13,16,27 Our results suggest that the use of Ligasure and Harmonic Scalpel in haemorrhoidectomy offers the surgeon significant advantages. The procedure is safe, fast, easy to perform and associated with less post-operative pain and less wound healing time in most of the patients.
Conclusion Ligasure and Harmonic Scalpel provide a superior alternative to conventional diathermy in haemorrhoidectomy by reducing the operative time, post-operative pain, analgesic requirements during the first 24 h post-operatively and time to complete healing of wounds.
References 1. Goligher J. Surgery of the Anus, Rectum, and Colon, 5th edn. London: Baillière Tindall, 1984. 2. El Nakeeb AM, Fikry AA, Omar WH. Rubber band ligation for 750 cases of symptomatic hemorrhoids out of 2200 cases. World J. Gastroenterol. 2008; 14: 6525–30. 3. MacRae HM, McLeod RS. Comparison of hemorrhoidal treatment modalities: a meta-analysis. Dis. Colon Rectum 1995; 38: 687–94. 4. Kaufmann HD. Outpatient treatment of hemorrhoids by cryotherapy. Br. J. Surg. 1976; 63: 462–3. 5. Milligan ETC, Morgan CN. Surgical anatomy of the anal canal and operative treatment of hemorrhoids. Lancet 1937; 2: 1119–24. 6. Mathai V, Ong BC, Ho Y. Randomized controlled trial of lateral internal sphincterotomy with hemorrhoidectomy. Br. J. Surg. 1996; 83: 380–2. 7. Longo A Treatment of hemorrhoids disease by reduction of mucosa and hemorrhoidal prolapse with a circular suturing device: a new procedure. Proceedings of the 6th World Congress of Endoscopic Surgery. Rome, Italy, June 3–6, 1998.
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8. Mehigan BJ, Monson JR, Hartley JE. Stapling procedure for hemorrhoids versus Milligan–Morgan hemorrhoidectomy: randomized controlled trial. Lancet 2000; 355: 782–5. 9. Armstrong DN, Ambroze WL, Schertzer ME, Orangio GR. Harmonic Scalpel vs. electrocautery hemorrhoidectomy: a prospective evaluation. Dis. Colon Rectum 2001; 44: 558–64. 10. Chung Y, Wu H. Clinical experience of sutureless closed hemorrhoidectomy with Ligasure™. Dis. Colon Rectum 2003; 46: 87–92. 11. Kennedy JS, Stranahan PL, Taylor KD, Chandler JG. Highburst strength, feed-back controlled bipolar vessel sealing. Surg. Endosc. 1998; 12: 876–8. 12. Jayne DG, Botterill I, Ambrose NS, Brennan TG, Guillou PJ, O’Riordain DS. Randomized clinical trial of Ligasure™ versus conventional diathermy for day-case hemorrhoidectomy. Br. J. Surg. 2002; 89: 428–32. 13. Thorbeck CV, Montes MF. Hemorrhoidectomy: randomized controlled clinical trial of Ligasure™ compared with Milligan–Morgan operation. Eur. J. Surg. 2002; 168: 482–4. 14. Palazzo FF, Francis DL, Clifton MA. Randomized clinical trial of Ligasure™ versus open hemorrhoidectomy. Br. J. Surg. 2002; 89: 154–7. 15. Franklin EJ, Seetharam S, Lowney J, Horgan PG. Randomized, clinical trial of Ligasure™ vs. conventional diathermy in hemorrhoidectomy. Dis. Colon Rectum 2003; 46: 1380–3. 16. Milito G, Gargiani M, Cortese F. Randomized trial comparing Ligasure™ hemorrhoidectomy with the diathermy dissection operation. Tech. Coloproctol. 2002; 6: 171–5. 17. 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: 482–6. 18. Bessa SS. Ligasure™ vs conventional diathermy in excisional hemorrhoidectomy: a prospective, randomized study. Dis. Colon Rectum 2008; 51: 940–4. 19. Olivera L, Wexner SD. Anal incontinence. In: Beck DE, Wexner SD (eds). Fundamentals of Anorectal Surgery, 2nd edn. London: WB Saunders, 1998; 115–52. 20. McCarus SD. Mechanism of ultrasonically activated scalpel. J. Am. Assoc. Gynecol. Laparosc. 1996; 3: 601–8. 21. Kwok SY, Chung CC, Tsui KK, Li MK. A double-blind, randomized trial comparing Ligasure and Harmonic Scalpel hemorrhoidectomy. Dis. Colon Rectum 2005; 48: 344–8. 22. Chung CC, Ha JP, Tai YP, Tsang WW, Li MK. Double-blind, randomized trial comparing Harmonic Scalpel hemorrhoidectomy, bipolar scissors hemorrhoidectomy, and scissors excision: ligation technique. Dis. Colon Rectum 2002; 45: 789–94. 23. Tan JJ, Seow-Choen F. Prospective, randomized trial comparing diathermy and harmonic scalpel hemorrhoidectomy. Dis. Colon Rectum 2001; 44: 677–9. 24. Ivanov D, Babovic´ S, Selesi D, Ivanov M, Cvijanovic´ R. Harmonic scalpel hemorrhoidectomy: a painless procedure? Med. Pregl. 2007; 60: 421–6. 25. Ozer MT, Yigit T, Uzar AI et al. A comparison of different hemorrhoidectomy procedures. Saudi Med. J. 2008; 29: 1264–9. 26. Abo-hashem AA, Sarhan A, Aly AM. Harmonic Scalpel compared with bipolar electro-cautery hemorrhoidectomy: a randomized controlled trial. Int. J. Surg. 2010; 8: 243–7. 27. Sayfan J, Becker A, Koltun L. Sutureless closed hemorrhoidectomy: a new technique. Ann. Surg. 2001; 234: 21–4.
Ligasure, Harmonic Scalpel versus conventional diathermy in excisional haemorrhoidectomy: a randomized controlled trial Ahmed Talha,* Samer Bessa† and Moataza Abdel Wahab‡ *Department of Surgery, Medical Research Institute, Alexandria University, Alexandria, Egypt †Department of Surgery, Faculty of Medicine, Alexandria University, Alexandria, Egypt and ‡Department of Biostatistics, High Institute of Public Health, Alexandria University, Alexandria, Egypt
Key words diathermy, haemorrhoidectomy, haemorrhoids, Harmonic Scalpel, Ligasure. Correspondence Dr Ahmed Talha, Department of Surgery, Medical Research Institute, Alexandria University, 165 Horreya Avenue, Hadara, Alexandria 21561, Egypt. Email: [email protected] A. Talha MD, MRCS; S. Bessa MD; M. Abdel Wahab PhD. Accepted for publication 28 July 2014. doi: 10.1111/ans.12838
Abstract Background: This study was designed to compare the surgical outcomes of haemorrhoidectomy performed by the Ligasure, Harmonic Scalpel with that performed by the conventional diathermy. Methods: A total of 180 patients were randomized to Ligasure, Harmonic Scalpel and diathermy haemorrhoidectomy, 60 patients for each group. The operative time, postoperative pain scores, parenteral analgesic requirements in the first 24 h, postoperative complications and wound healing rates were documented. Results: The median operative time was 8 min (range, 7–18) for the Ligasure and Harmonic Scalpel groups and 18 min (range, 15–21) for the diathermy group (P < 0.001). Throughout the first post-operative week, the daily median pain score was lower in the Ligasure and Harmonic Scalpel groups than in the diathermy group (P < 0.001). The median number of analgesic ampoules during the first 24 h postoperatively was lower in the Ligasure and Harmonic Scalpel groups (P < 0.001). There was no statistically significant difference in the incidence of post-operative complications. At 6 weeks post-operation, more patients in the Ligasure and Harmonic Scalpel groups had complete healing of wounds (P = 0 < 0.001). Conclusion: Ligasure and Harmonic Scalpel provide a superior alternative to conventional diathermy in haemorrhoidectomy with no difference between them in reducing the operative time, post-operative pain, analgesic requirements during the first 24 h and time to complete healing of wounds.
Introduction Haemorrhoidectomy is a known painful procedure and this reputation, in combination with the high prevalence of haemorrhoidal disease, has generated much interest in outpatient treatments of haemorrhoids.1 Rubber-band ligation, injection sclerotherapy, infrared photocoagulation and cryotherapy have been used with some success, but the results are inferior to surgery.1–4 Surgical treatment, reserved for patients with prolapsing haemorrhoids, consists of excision and ligation of the ‘pile’ with or without closure of the defect. Milligan–Morgan haemorrhoidectomy, as described in 1937,5 remains the most popular technique. Considerable research over the last two decades has concentrated on reducing pain following these surgical procedures. The research was mainly directed towards three areas: analgesic delivery during the post-operative © 2014 Royal Australasian College of Surgeons
period, modification of the surgical technique and the use of a variety of surgical instruments in the hope of decreasing post-operative pain.1,3 Modifications include open, semi-open,1,3 closed incisions,1 routine performance of lateral internal sphincterotomy6 and the use of stapling devices as advocated by Longo and colleagues.7,8 Among these modifications are the use of diathermy pedicle coagulation,9 the Harmonic Scalpel (Ethicon, Cincinnati, OH, USA)9 and the Ligasure System (Valleylab, Boulder, CO, USA).10–12 Several studies have suggested that both the Harmonic Scalpel and the Ligasure System were associated with less postoperative pain compared with the conventional diathermy.10–24 Motivated by these reports, this study was designed to compare the surgical outcomes of haemorrhoidectomy performed by Ligasure, Harmonic Scalpel with that performed by conventional diathermy. ANZ J Surg •• (2014) ••–••
2
Talha et al.
Fig. 1. Trial flowsheet showing progress through the phases of the trial. Total number of patients considered for study participation n = 240
Eligable n = 200
Randomized to Harmonic ScalpelTM n = 66
Refused to continue n=2
Lost followup n=4
Continued till the end n = 60
Randomized to LigasureTM n = 67
Refused to continue n=0
Lost followup n=7 Continued till the end n = 60
Not eligable n = 40 Randomized to diathermy n = 67
Refused to continue n=1
- Previous anal surgery n = 12 - Concomittent anal pathology requiring surgery n = 18 - Refused to participate n = 10
Lost followup n=6 Continued till the end n = 60
Study design and randomization This study was approved by the Ethics Committee of the Faculty of Medicine and Medical Research Institute, University of Alexandria. Patients who fulfilled the inclusion and exclusion criteria and completed the follow-up for 1 year were included in the study; they were 180 patients from March 2010 through October 2012. Eligible patients were randomly assigned using sealed opaque envelopes containing computer-generated random numbers into one of the three groups: the Ligasure, Harmonic Scalpel or diathermy haemorrhoidectomy (Fig. 1). A written informed consent was obtained from all participants. Inclusion criteria included symptomatic grades III or IV haemorrhoids (fresh rectal bleeding, itching, anal discomfort or prolapse). Exclusion criteria included previous anal surgery, any degree of focal incontinence, concomitant anal conditions requiring surgical treatment at the time of haemorrhoidectomy, for example fissure or fistula.
Procedures All operations were performed under a standardized spinal anaesthesia with the patient in the prone jackknife position. A standardized, three-quadrant haemorrhoidectomy was performed in all patients. The medium-sized Hill Ferguson retractor (CS Surgical, Inc., Los Angeles, CA, USA) was used in all procedures. Each haemorrhoidal cushion was managed as follows. For Ligasure haemorrhoidectomy, three applications of the Axs handle were required to excise each haemorrhoidal cushion. The first application included the perianal skin, including the external component of the cushion; the second included the part overlying the internal sphincter; and the third included the pedicle 0.5 cm above the dentate line. After each application, completion of coagulation was signalled by the characteristic two-tone sound and cutting along the middle of the line of the coagulum until complete excision of the cushion was achieved. For Harmonic Scalpel haemorrhoidectomy, we used the ‘scissor’ configuration (Coagulating Shears Model, Ethicon). After each application, completion of coagulation and cut along the middle of the line of the coagulum until complete excision of the haemorrhoidal cushion was achieved.
For diathermy haemorrhoidectomy, a V-shaped incision was made in the perianal skin distal to the cushion to include the external component then, dissecting the haemorrhoidal tissue from the internal sphincter. The pedicle was transfixed 0.5 cm above the dentate line using Vicryl 3/0 sutures (Ethicon, Johnson & Johnson International, Sint-Stevens-Woluwe, Belgium). Haemorrhoidal tissue was excised and the wound was left open.
Post-operative course and outcome measurement The operative time was calculated by an independent observer. Pain was assessed post-operatively using a visual analogue scale from 1 to 10. Patients were asked to score their pain in the morning of the first seven post-operative days. Daily and weekly median scores were calculated for each group. Patients were given diclofenac potassium 75 mg intra-muscular injections as required, and the number of ampoules required during the first 24 h post-operatively was recorded. Early post-operative complications, for example haemorrhage and urine retention, were recorded. Patients were kept in the hospital overnight and were discharged in the morning of the first post-operative day. Discharge medication was standardized and included diclofenac potassium tablets 50 mg t.d.s, metronidazole 400 mg t.d.s., Lactulose 20 mL b.i.d and glyceryl trinitrate cream 0.2% topically t.d.s. Follow-up was performed by two independent assessors who were blinded to the operative technique used and assessing patients’ outcome. It was performed by inspection of the wound in the outpatient clinic on a weekly basis for the first six weeks and then at 3, 6 and 12 post-operative months assessing wound healing, symptoms control and complications.
Statistical analysis Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) version 16 software (SPSS, Inc., Chicago, IL, USA). Significance was set at a P-value < 0.05. The chi-squared test was used to compare characteristics of the sample, namely gender, grade of haemorrhoids and duration of disease. One-way analysis of variance (ANOVA) was used to compare the three groups © 2014 Royal Australasian College of Surgeons
Ligasure, harmonic & diathermy in haemorrhoidectomy
3
regards their age, sex, duration of complaint and grade of haemorrhoids (Table 1). The median operative time was significantly higher in diathermy than Ligasure and Harmonic Scalpel groups (Table 2). In the Ligasure and Harmonic Scalpel groups the dissection was entirely bloodless in all patients. Throughout the first seven postoperative days, the daily median pain score was lower in the Ligasure and Harmonic Scalpel groups than in diathermy group (P < 0.0001; Fig. 2) where there is a significant difference between groups and among the same group along first 7 days (Fig. 2). The median weekly pain score was significantly higher in diathermy than the other two groups (Table 2). The median number of analgesic ampoules required during the first 24 h post-operatively was 2 (range, 0–3) in the Ligasure and Harmonic Scalpel and 3 (range, 1–3) in the diathermy (P < 0.001; Table 2). Post-operative complications were encountered in two patients (3.3%) in each of the Ligasure and Harmonic Scalpel groups, and in seven patients (11.7%) in the diathermy group with the difference being statistically insignificant. Urine retention requiring temporary catheterization was encountered in two patients (3.3%) in the Ligasure and Harmonic Scalpel groups, and in five patients (8.33%) in the diathermy group with the difference being statistically insignificant. None of the patients in the Ligasure and Harmonic Scalpel groups developed reactionary haemorrhage compared with two patients (3.33%) in the diathermy group with the difference being statistically insignificant. In these two patients, reactionary
as regards their age. It is worth mentioning that all patients suffered no pain preoperatively (baseline). Significance in pain score change was detected using repeated measures ANOVA (with Bonferroni correction), including type of intervention and grade of haemorrhoids as potential independent factors that may affect pain score and its change along the 7 days post-operation. Kruskal–Wallis test was used to compare median operative time, average week pain score, analgesic requirements (ampoules) and hospital stay among the three procedures. Reductions in post-operative pain of 50% and >30% in the operative time were clinically relevant, and these were chosen as parameters with which to calculate the sample size.14 For the results obtained in the current study, at alpha level 0.05, the power of detection of difference between Ligasure and Harmonic Scalpel groups (60 patients each) versus diathermy group (60 patients) was 100%, yet the power to detect statistical difference in pain scores between Ligasure and Harmonic Scalpel groups was low and it needs a much higher sample size to detect statistically significant difference between these groups.
Results The data revealed 180 patients with complete follow-up for at least 1 year (Fig. 1). There were 118 men (65.6%) and 62 women (34.4%). There was no significant difference between the three groups as
Table 1 Characteristics of study sample by type of operation Type of operation Ligasure group Number (n = 60) Age (years) mean ± SD Gender Male Female Duration (months) >12 12–24 >24 Grade III IV
Harmonic Scalpel group %
Number (n = 60)
33 ± 13
%
Test of significance
Diathermy group Number (n = 60)
33 ± 12
%
Total Number (n = 180)
32 ± 11
%
33 ± 12
F = 0.172, P = 0.842
39 21
65.0 35.0
37 23
61.7 38.3
42 18
70.0 30.0
118 62
65.6 34.4
χ2 = 0.935 P = 0.627
17 21 22
28.3 35.0 36.7
17 21 22
28.3 35.0 36.7
11 22 27
18.3 36.7 45.0
45 64 71
25.0 35.6 39.4
χ2 = 2.335 P = 0.674
24 36
40.0 60.0
24 36
40.0 60.0
21 39
35.0 65.0
69 111
38.3 61.7
χ2 = 0.423 P = 0.809
SD, standard deviation.
Table 2 Type of operation, operative and post-operative parameters Type of operation Ligasure group Number (n = 60)
Operative time Average weekly pain score Analgesic requirements (ampoules) Hospital stay Post-operative complications Urine retention Bleeding
%
(7–18), 8.0 (2.57–6.86), 4.5 (0–3), 2.0 (1–1), 1.0 2 0
© 2014 Royal Australasian College of Surgeons
3.33 0.00
Harmonic Scalpel group Number (n = 60)
%
(min–max), median (7–18), 8.0 (2.57–6.86), 4.43 (0–3), 2.0 (1–1), 1.0 2 0
3.33 0.00
Test of significance
Diathermy group Number (n = 60)
%
Total Number (n = 180)
Kruskal–Wallis test χ2 = 119.7, P = 0.0001 2 χ = 114.1, P = 0.0001 χ2 = 95.2, P = 0.0001 χ2 = 4.02, P = 0.134
(15–21), 18.0 (6–8.29), 7.14 (1–3), 3.0 (1–2 (2 cases)), 1.0 5 2
8.33 3.33
%
9 2
5.00 1.11
χ2 = 2.11, P = 0.349 χ2 = 4.04, P = 0.132
4
Talha et al.
Estimated marginal means of pain score 8
Pain score
7 6 5 4 3 Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
Fig. 2. Estimated mean pain score along 7 days post-operative by type of intervention. ( ) Ligasure group; ( ) Harmonic Scalpel group; ( ) diathermy group.
haemorrhage developed the night of the operation necessitating packing under anaesthesia. In the Ligasure group, the hospital stay was 1 day for all patients. In the diathermy group, it was 1 day in 58 patients (96.67%) and 2 days in the two patients (3.33%) who developed reactionary haemorrhage. At the end of the first postoperative week, it was observed that all wounds in the Ligasure and Harmonic Scalpel groups were open and were not closed as was the case at the end of the operation. At the end of the sixth post-operative week, complete healing of all wounds was observed in all patients in the Ligasure and Harmonic Scalpel groups (100%) compared with 46 patients (76.67%) in the diathermy group. This difference in the healing rate at 6 weeks post-operatively was statistically significant (P = 0.0001). At the end of the third month, all wounds were healed, all patients were free of symptoms, also faecal incontinence scores were as preoperative values in the three groups using a validated continence scoring system.19 At the end of the 6 and 12 post-operative months, neither recurrences nor anal stenosis were detected in any of the three groups.
Discussion The main finding of the present study was that the use of both the Harmonic Scalpel and the Ligasure system was associated with less post-operative pain compared with the use of diathermy. Harmonic Scalpel has been used in haemorrhoidectomy and is compared with the Ligasure in a randomized controlled trial done by Kwok et al.,21 which showed the post-operative pain score and postoperative oral analgesic requirement and the operative time were significantly less in the Ligasure group. The use of an ultrasonic device was associated with more post-operative pain. Such results are not in agreement with those of the present study. The results of the present study showed no significant difference between them in terms of post-operative pain, analgesic requirements and the operative time. This discrepancy could be explained by a relatively small number of patients included in their study to build up a more comprehensive conclusion. In the present study, we standardized many variables to avoid variation in the results of pain assessment by excluding patients with other ano-rectal pathology and patients with neurological defects or
chronic pain syndromes and those currently taking narcotic analgesics. Regarding the surgical technique, we used standard spinal anaesthesia and the open method to avoid the debate around the effect of using the closed technique on post-operative pain perception. This study clearly demonstrates the superior pain control profile of Harmonic Scalpel in comparison with diathermy haemorrhoidectomy and also the less need for analgesics. Similar results were obtained by Armstrong et al.,9 but they used both open and closed techniques, which is a potential flaw in their study, although it did not affect their final conclusion. Chung et al.22 reported that Harmonic Scalpel is superior to bipolar scissors haemorrhoidectomy because it is associated with less postoperative pain and hence better patient satisfaction. However, these observed benefits were small and the time off work to regain normal activity remained similar. But Tan et al.23 reported that Harmonic Scalpel is nearly comparable with diathermy haemorrhoidectomy in terms of post-operative pain and complications. In our study, this was not the case, as there was a significant reduction in post-operative pain and less analgesic consumption in Harmonic Scalpel compared with diathermy haemorrhoidectomy. Our results are comparable with those of Ivanov et al.,24 Ozer et al.25 and Abo-Hashem et al.26 who reported that Harmonic Scalpel haemorrhoidectomy has a significant reduction in post-operative pain scoring, induced better haemostasis and less analgesic consumption. In the present study, a significant wound healing difference was found at 6 weeks post-operatively between Harmonic Scalpel and diathermy where complete wound healing was noticed in all patients in the Harmonic Scalpel group (100%) compared with (76.67%) in the diathermy group. Similar results have been presented by AboHashem et al.26 who found a significant fast wound healing in Harmonic Scalpel haemorrhoidectomy. This higher rate of wound healing at 6 weeks post-operatively could be explained by minimal tissue trauma, minimal charring, no tissue necrosis and less local oedema in the surrounding tissues.26 Our study has revealed significant differences in the surgical outcomes of haemorrhoidectomy performed by the Ligasure and that performed by the conventional diathermy in terms of operative time, post-operative pain and analgesic requirements during the first 24 h after surgery, and the rate of complete wound healing at 6 weeks post-operatively. In accordance with all earlier studies comparing Ligasure with diathermy in haemorrhoidectomy, the median operative time for Ligasure was significantly shorter than diathermy haemorrhoidectomy.10,12–17,27 Similarly, earlier studies have confirmed the absolute bloodlessness of Ligasure haemorrhoidectomy and so did the present study.10,12–17,27 This characteristic was believed to be a significant advantage of this technique for two reasons: (i) the operative time was shortened because no time was required to secure haemostasis or to ligate the pedicles; and (ii) the perfect haemostasis produced by Ligasure has made the operative technique simpler, easier and quicker. Jayne et al.,12 Palazzo et al.14 and Milito et al.16 found that although Ligasure haemorrhoidectomy was not associated with a significant reduction in post-operative pain, it was associated with a © 2014 Royal Australasian College of Surgeons
Ligasure, harmonic & diathermy in haemorrhoidectomy
significant reduction in the median number of analgesic consumption in the post-operative course. Others10,17 found that Ligasure haemorrhoidectomy was associated with significant less postoperative pain and parenteral analgesic requirements compared with Ferguson haemorrhoidectomy. Franklin et al.15 and Thorbeck and Montes13 found that Ligasure haemorrhoidectomy was associated with a significant reduction in both post-operative pain and analgesic requirements in the immediate post-operative period and 24 h later. In the present study, Ligasure haemorrhoidectomy was found to be associated with a significant reduction in both post-operative pain in the first post-operative week and analgesic requirements during the first 24 h post-operatively. In the present study, complete healing of all wounds was found in all patients in the Ligasure group (100%) compared with (76.67%) in the diathermy group at 6 weeks post-operatively, which is statistically significant. Similar results have been obtained by Sayfan et al.,27 Milito et al.,16 and Thorbeck and Montes13 who found a significant faster wound healing in Ligasure haemorrhoidectomy. The minimal tissue trauma produced by the Ligasure, minimal charring, no tissue necrosis and less oedema in the surrounding tissue is proposed to be responsible for this higher rate of wound healing at 6 weeks post-operatively.13,16,27 Our results suggest that the use of Ligasure and Harmonic Scalpel in haemorrhoidectomy offers the surgeon significant advantages. The procedure is safe, fast, easy to perform and associated with less post-operative pain and less wound healing time in most of the patients.
Conclusion Ligasure and Harmonic Scalpel provide a superior alternative to conventional diathermy in haemorrhoidectomy by reducing the operative time, post-operative pain, analgesic requirements during the first 24 h post-operatively and time to complete healing of wounds.
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