Randomized, clinical trial of Ligasure vs conventional diathermy in hemorrhoidectomy. Clinical experience of sutureless closed hemorrhoidectomy with LigaSure. Ligasure Precise vs. conventional diathermy for Milligan-Morgan hemorrhoidectomy: a prospective, randomized, multicenter trial. One year follow up of a randomized trial comparing Ligasure with open haemorrhoidectomy. Randomised trial comparing LigaSure haemorrhoidectomy with the diathermy dissection operation. Randomized controlled trial of LigaSure with submucosal dissection versus Ferguson hemorrhoidectomy for prolapsed hemorrhoids. Ligasure vs. conventional diathermy in excisional hemorrhoidectomy: a prospective, randomized study. Ligasure trademark vs conventional diathermy haemorrhoidectomy: long-term follow-up of a randomised clinical trial. Randomized clinical trial of Ligasure versus open haemorrhoidectomy. Randomized clinical trial of stapled hemorrhoidectomy vs open with Ligasure for prolapsed piles. Randomized clinical trial of Ligasure versus conventional diathermy for day-case haemorrhoidectomy. Haemorrhoidectomy: randomised controlled clinical trial of Ligasure compared with Milligan-Morgan operation. Randomized clinical trial comparing LigaSure haemorrhoidectomy with open diathermy haemorrhoidectomy. Randomized clinical trial of LigaSure and conventional diathermy haemorrhoidectomy.
Hemorrhoidectomy is frequently associated with significant postoperative pain, and new techniques to reduce this pain are constantly under evaluation. The present study was conducted to determine the usefulness of the Ligasure system and compare it with conventional diathermy for hemorrhoidectomy.
                Thirty-four consecutive patients with Grade 3 or 4 hemorrhoids requiring surgery were recruited and randomized into two groups by preoperative assignment of sealed envelopes. Patients with coexisting perianal disease, previous perianal surgery, or thrombosed hemorrhoids were excluded. All patients were anesthetized and operated on by a single team. In one group, monopolar diathermy in the coagulation mode was used to dissect hemorrhoidal tissue from the internal sphincter. In the second group, tissue was coagulated by Ligasure and then divided with scissors. Operating time was documented by theater staff. Postoperatively, pain scores and Cleveland Clinic incontinence scores were documented.
                Seventeen patients were randomized into each group. There were no significant differences in age, gender, or clinical symptoms between the groups. The mean operating time in the Ligasure group was 6 (range, 4-10) minutes compared with 11 (range, 7-20) minutes in the other group, and this was statistically significant (P < 0.001). Patients in the Ligasure group reported significantly less pain with first defecation and at postoperative Days 1 and 14 (P < 0.001). The mean hospital stay in both groups was one (range, 1-5) day, and there was no difference in the incontinence scores.
                Ligasure diathermy provides a superior alternative to conventional diathermy in hemorrhoidectomy by reducing operating time and postoperative pain. The purpose of this study was to evaluate the LigaSure vessel sealing system as an alternative to closed hemorrhoidectomy.
                Sixty-one patients with Grade 3 or 4 symptomatic hemorrhoids were prospectively randomly assigned to undergo hemorrhoidectomy with the LigaSure vessel sealing system or hemorrhoidectomy using the conventional Ferguson procedure. We determined the operation time, postoperative pain, amount of time taken off from work, and complications associated with both techniques.
                Mean operative time for the LigaSure hemorrhoidectomy was 15 +/- 5.4 minutes and for the Ferguson operation, 21.2 +/- 8.2 minutes. The difference was significant (P < 0.01). There was also a significant decrease in pain measurements reported on postoperative Days 1 and 2 (P < 0.05) in the LigaSure group. The incidence of postoperative wound swelling and complications were similar between two groups. There was no difference in the period of time off from work between patient groups.
                This study confirms that LigaSure system can achieve a radical ablation of hemorrhoids, reduce operative time, and result in less postoperative pain on postoperative Days 1 and 2. Milligan-Morgan hemorrhoidectomy using radiofrequency dissection (Ligasure) has been proposed instead of conventional diathermy in view of its potential benefits in terms of postoperative anal pain and better hemostatic control, but the medical literature is still controversial. This multicenter, randomized, controlled trial was designed to compare the outcomes between Ligasure and conventional diathermy hemorrhoidectomy in the Milligan-Morgan procedures in a sufficient number of patients.
                Patients with Grades III and IV hemorrhoids were randomized to two groups: Ligasure hemorrhoidectomy and conventional diathermy. Postoperative anal pain was measured by the Visual Analog Scale (VAS) and the analgesia required. Postoperative complications, wound healing, and return to working activities also were evaluated as secondary outcomes.
                A total of 273 patients, well matched for age, gender, working activity and grade of hemorrhoids, were randomized to two groups: Ligasure 146, and diathermy 127. The severity of postoperative anal pain was significantly less in the Ligasure group when measured at least 12 hours after defecation (P < 0.01), whereas it was similar at the time of defecation. The Ligasure group had significantly lower requirements for painkiller pills. There were no significant differences in early and late complications. Return to work and normal activities was significantly faster in the Ligasure group.
                Ligasure hemorrhoidectomy is an effective procedure for Grades III and IV hemorrhoids and facilitates a faster return to work and normal activities by reducing postoperative pain. Ligasure haemorrhoidectomy is an effective treatment for prolapsing haemorrhoids, however, concerns exist regarding potential damage to the anal sphincters.
                Patients previously included into a randomized trial comparing open and Ligasure haemorrhoidectomy were contacted by postal questionnaire to evaluate their overall satisfaction and continence at 12 months post operatively.
                Thirteen patients who underwent open and 17 who underwent Ligasure haemorrhoidectomy were evaluated. Three patients from the open group and 2 from the Ligasure group were unhappy with the result (P = 0.37) and minor incontinence was reported in 5 Ligasure and 2 open patients (P = 0.42).
                Patient satisfaction and post operative continence scores at 1 year post operatively are comparable for open and Ligasure haemorrhoidectomy. The study was designed to compare LigaSure haemorrhoidectomy with open haemorrhoidectomy performed by means of diathermy excision. Fifty-sixty consecutive patients with third- and fourth-degree haemorrhoids were randomly allocated to undergo either LigaSure haemorrhoidectomy (29 patients) or diathermy haemorrhoidectomy (27 patients). All patients were evaluated for operative time, pain, post-operative analgesic requirements, time to first bowel movement, length of hospital stay, wound healing period, time to return to work, and occurrence of early postoperative complications (such as urinary dysfunction, bleeding, soiling, seepage, continence disorders) and late complications (such as stenosis). A statistically significant advantage was observed in the patients who received the LigaSure technique as far as concerns length of operative time (9.2 vs. 12.2 min, p<0.001), post-operative analgesic requirements (14.1 vs. 16.8 administrations, p<0.001), wound healing period (16.3 vs. 37.5 days, p< 0.0001), and time to return to work (8.3 vs. 18.3 days, p<0.01). No significant difference was seen in the postoperative pain score, complications rate, first bowel motion or hospital stay. No recurrence was observed at the 6-month follow-up. In conclusion, our experience shows that the LigaSure haemorrhoidectomy offers definite advantages over the classic diathermy technique. This procedure is easier, safer, and more rapid to perform and is followed by a faster wound healing time, a significantly shorter hospital stay, less postoperative pain and faster wound healing. The aim of this study was to compare the outcomes between the LigaSure vessel sealing system and the conventional closed Ferguson hemorrhoidectomy procedure performed by diathermy.
                A series of 84 patients with grades III and IV hemorrhoids were randomized into two groups: (1) LigaSure hemorrhoidectomy with submucosal dissection (42 patients) and (2) Ferguson hemorrhoidectomy (42 patients). The patient demographics, operative details, parenteral analgesic requirement, postoperative pain score (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, and 8 weeks after surgery.
                There were no statistically significant differences between the two groups in terms of age, gender, duration of symptoms, grade of the hemorrhoid(s), or number of hemorrhoids resected. The mean operating time for LigaSure hemorrhoidectomy with submucosal dissection was significantly shorter than that for the Ferguson hemorrhoidectomy (11.3 +/- 0.4 vs. 34.2 +/- 0.7 minutes; P < 0.0001). Patients treated with the LigaSure method had significantly less blood loss (P < 0.0001), a better pain score (P < 0.0001), less parenteral analgesic requirement (P < 0.0001), shorter hospital stay (P < 0.0001), and less time off from work or normal activity (P < 0.0001). There was no difference in the early and delayed postoperative complications between the two groups.
                LigaSure hemorrhoidectomy with submucosal dissection is a safe, effective procedure for grade III and IV hemorrhoids. Patients derive greater short-term benefits: reduced intraoperative blood loss, operating time, and postoperative pain as well as earlier resumption of work or normal activity. Long-term follow-up with a larger number of patients is required to confirm the long-term results of this procedure. This study was designed to compare the surgical outcomes of hemorrhoidectomy performed by the Ligasure with that performed by the conventional diathermy.
                A total of 110 patients were randomized to Ligasure (55 patients) or diathermy (55 patients) hemorrhoidectomy. The operative time, postoperative pain scores, parenteral analgesic requirements in the first 24 hours, postoperative complications, and wound healing rates at six weeks postoperatively were documented.
                The median operative time was 8 (range, 7-10) minutes for the Ligasure group and 18 (range, 15-21) minutes for the diathermy group (P < 0.001). Throughout the first postoperative week, the daily median pain score was lower in the Ligasure group than in the diathermy group (P < 0.001). The median number of analgesic ampoules during the first 24 hours postoperatively was lower in the Ligasure group (P < 0.001). There was no statistically significant difference in the incidence of postoperative complications. At six weeks postoperatively, more patients in the Ligasure group had complete healing of wounds (P = 0).
                Ligasure provides a superior alternative to conventional diathermy in hemorrhoidectomy by reducing the operative time, postoperative pain, parenteral analgesic requirements during the first 24 hours postoperatively, and the time to complete healing of wounds. Ligasure haemorrhoidectomy has short-term benefits over conventional diathermy haemorrhoidectomy. The current study aimed to determine the long-term efficacy of Ligasure haemorrhoidectomy.
                Forty patients, previously randomised to Ligasure or diathermy haemorrhoidectomy in 2002, were invited to participate in the study. Haemorrhoidal symptoms and patient satisfaction were recorded. Incontinence was quantified and sphincter anatomy and function assessed by endoanal ultrasound and anorectal manometry.
                Thirty (75%) patients participated in the study (14 Ligasure, 16 conventional). There was no difference in age, sex distribution, or length of follow-up (Ligasure : 37 months; conventional: 36 months) between the groups. Both techniques achieved good symptom control, but with a trend to less recurrent bleeding following Ligasure. Incontinence scores and patient satisfaction were similar. A significant difference was observed in internal sphincter thickness (Ligasure : 2.5 mm, 2.2-2.8 (mean, 95%CI) vs conventional: 1.88 mm, 1.7-2.1, P = 0.005) and rectal urge sensation (Ligasure : 284 mls, 211-378 vs conventional: 173 mls, 129-217, P = 0.08).
                Ligasure is as effective as conventional diathermy haemorrhoidectomy in achieving long-term symptom control. Less radical haemorrhoidal excision with the Ligasure could explain the differences in internal sphincter thickness and urge sensation, and might make it the preferred method for patients with compromised sphincter function. Postoperative pain associated with open haemorrhoidectomy remains problematic. Haemorrhoidectomy performed using bloodless bipolar diathermy--Ligasure--may have advantages over conventional open haemorrhoidectomy in terms of operating time and postoperative pain.
                Thirty-four patients were randomized to undergo Ligasure (18 patients) or diathermy (16) haemorrhoidectomy. The operating time, amount of pain and postoperative analgesic requirement, postoperative complications and overall patient satisfaction were documented.
                The median duration of operation was shorter in the Ligasure haemorrhoidectomy group (5.1 versus 9.2 min; P < 0.001). There was no statistically significant difference in the postoperative pain score, but the median analgesic requirement was lower in the Ligasure group (850 versus 1600 mg tramadol; P = 0.013). Patient satisfaction was similar in both groups.
                Ligasure haemorrhoidectomy is quick and bloodless and, although as painful as diathermy haemorrhoidectomy, is associated with a reduced analgesic requirement. The aim of the study was to compare the results in 95 patients randomly allocated to undergo either stapled or open hemorrhoidectomy using Ligasure.
                Ninety-five patients with grade III and IV hemorrhoids were randomly allocated to undergo either stapled (50 patients) or open using Ligasure (45 patients). Stapled hemorrhoidectomy was performed with the use of a circular stapling device. Open hemorrhoidectomy was accomplished according to the Milligan-Morgan technique by using Ligasure. Postoperative pain was assessed by means of a visual analog scale (VAS). Recovery evaluation included return to pain-free defecation and normal activities. A 6-month clinical follow-up and an 18 (12-24) month median telephone follow-up were obtained in all patients.
                Operation time for open hemorrhoidectomy using Ligasure was shorter [median 13 (range 9.2-16.1) min vs 15 (range 8-17) minutes, p < 0.05]. Median range of VAS score in the stapled group were significantly lower [VAS score after 8 h: 3 (2-6) vs 5 (3-8), p < 0.01; VAS score after first defecation: 5 (3-8) vs 7 (3-9), p < 0.001. The stapled hemorrhoidectomy was associated with an increased incidence of intraoperative bleeding in 18 cases (36%) vs four cases (8.8%) of the Ligasure group. There were three cases (6%) from the stapled group with recurrence of the hemorrhoids and none from the open technique.
                Hemorrhoidectomy with a circular stapler device is easy to perform, but one more line of clips must be added to the device to avoid intraoperative bleeding from the cut line. Hemorrhoidectomy performed using Ligasure is more painful postoperatively but is a more radical operation. Haemorrhoidectomy is frequently associated with postoperative pain and prolonged hospital stay. A new technique of haemorrhoidectomy using the Ligasure device suited to day-case surgery is described. This technique was compared with conventional open diathermy haemorrhoidectomy.
                Forty patients with grade III or IV haemorrhoids were randomized to Ligasure (group 1) or conventional diathermy (group 2) haemorrhoidectomy. Operative details were recorded and patients recorded daily pain scores on a linear analogue scale. Follow-up was at 1, 3, 6 and 12 weeks to evaluate complications, return to normal activity, ongoing symptoms and patient satisfaction.
                Reduced intraoperative blood loss (median (range) 0 (0-5) ml versus 20 (12-22) ml; P < 0.001) and a shorter operating time (10 (8-11) versus 20 (18-25) min; P < 0.001) was observed in group 1 compared with group 2. More patients in group 1 were discharged on the day of operation (18 of 20 versus 11 of 20; P < 0.05) and there was a trend towards lower postoperative pain scores on day 1 (group 1 median 5 (95 per cent confidence interval (c.i.) 2.6 to 6.8) versus group 2 7 (95 per cent c.i. 4.2 to 7.7); P = 0.36). There was no difference between the two groups in the degree of patient satisfaction or number of postoperative complications.
                Ligasure diathermy may be used safely in the treatment of patients with grade III or IV haemorrhoids. It reduces intraoperative blood loss and operating time, and facilitates same-day discharge. To evaluate the efficacy of the Ligasure system in the management of haemorrhoids.
                Unblinded randomised clinical trial.
                Teaching hospital, Spain.
                112 patients with third and fourth degree haemorrhoids.
                For 56 patients we used Ligasure system and a variant of Milligan and Morgan's technique. For the other 56, we used the traditional technique.
                Postoperative pain.
                Operating times varied from 100 seconds for each haemorrhoidal cushion with Ligasure system to the 313 seconds by the traditional technique. The blood loss was not quantifiable in patients operated on with Ligasure. Pain was scored on a visual analogue scale. In the Ligasure group, the mean scores were 4.9 (immediate postoperative period) and 2.3 (24 hours later). In the other group, the scores were 7.8 and 6.9. These differences were significant.
                Haemorrhoidectomy using Ligasure as a technical variant of Milligan and Morgan's technique has important advantages. Milligan-Morgan excision haem-orrhoidectomy remains a very popular treatment modality for third and fourth degree haemorrhoids due to its cost effectiveness and good long-term results. The LigaSure tissue-sealing device is an alternative technique used in haemorrhoidectomy that has been shown to produce favourable results. The aim of this study was to assess the effectiveness of the LigaSure tissue sealing device in comparison with conventional diathermy haemorrhoidectomy.
                A prospective clinical trial was conducted. Patients with newly diagnosed haemorrhoids requiring haemorrhoidectomy were randomized to either LigaSure haemorrhoidectomy or diathermy haemorrhoidectomy. Surgical technique and postoperative care was standardized. Outcome measures were operative time and bleeding, postoperative pain (measured on a visual analogue scale) and rate of wound healing.
                We randomized 44 patients, 22 to LigaSure and 22 to diathermy; 43 patients were evaluated. They were aged between 19 and 71 years. There were no differences in patient demographics or type of haemorrhoid being operated on. LigaSure haemorrhoidectomy had a significantly lower mean operative time and intraoperative bleeding. At 3 weeks after surgery, haemorrhoidectomy performed with LigaSure had an odds ratio for complete epithelialization of 3.1 over diathermy (95% CI 1.2-8.2). There was no difference in postoperative pain.
                LigaSure haemorrhoidectomy is superior to diathermy for open haemorrhoidectomy. The aim of this randomized prospective trial was to compare LigaSure and conventional diathermy haemorrhoidectomy.
                Two hundred and eighty-four patients with grade III or IV haemorrhoids were randomized to LigaSure or diathermy (Milligan-Morgan) haemorrhoidectomy as a day-case procedure. Operating time, postoperative pain score, hospital stay, postoperative complications, wound healing time and time to return to normal activities were assessed. Thirty-four patients were lost to follow-up.
                The mean operating time for LigaSure haemorrhoidectomy was significantly shorter than that for diathermy (P = 0.011). Patients treated with LigaSure had significantly less postoperative pain (measured on a visual analogue scale; P = 0.010), a shorter wound healing time (defined as time to absence of swelling; P = 0.012) and less time off work (P = 0.010) than patients who had diathermy. Neither postoperative complications nor mean hospital stay (day-case surgery) were significantly different.
                LigaSure haemorrhoidectomy demonstrates simplicity, reproducibility, a low complication rate, fast wound healing, a quick return to work and reduced postoperative pain.
                Copyright (c) 2007 British Journal of Surgery Society Ltd.
Since the usage of the Ligasure technique results in significantly less immediate postoperative pain after hemoroidectomy without any adverse effect on postoperative complications, convalescence and incontinence-rate, this technique is superior in terms of patient tolerance. Although there was a tendency for equal efficacy, more evaluation of the long-term risk of recurrent hemorrhoidal disease is required.