|Year : 2015 | Volume
| Issue : 1 | Page : 27-33
Randomized comparative study of Ligasure versus conventional (Milligan-Morgan) hemorrhoidectomy
Olfat Issa El Sebaei, Alaa Abd El Azeem El Sisi, Mohamed Sabry Amar, Mohamed Ezzat El Sayed MBBCh
Department of General Surgery, Faculty of Medicine, Menoufia University, Menoufia, Egypt
|Date of Submission||27-Nov-2013|
|Date of Acceptance||02-Mar-2013|
|Date of Web Publication||29-Apr-2015|
Mohamed Ezzat El Sayed
24 Masqid Belal st. Gamaa, Mansoura
Source of Support: None, Conflict of Interest: None
The objective of this study was to evaluate the two approaches for hemorrhoid surgery - Ligasure hemorrhoidectomy and conventional (Milligan-Morgan) hemorrhoidectomy - in terms of operative time and blood loss, as well as postoperative pain, bleeding, analgesic requirement, urinary retention, discharge, stenosis, fecal incontinence, wound healing, and patient satisfaction.
To compare the surgical outcome of hemorrhoidectomy performed using Ligasure bipolar diathermy with conventional hemorrhoidectomy.
Patients and methods
Twenty patients with grade III or IV hemorrhoids were randomized equally to conventional hemorrhoidectomy (group 1) and Ligasure (group 2) hemorrhoidectomy. Operative details were recorded, and patients recorded daily pain scores on a linear analogue scale. Follow-up was weekly for 2 months and then monthly for 6 months to evaluate complications, return to normal activity, ongoing symptoms, and patient satisfaction.
The mean reduced intraoperative blood loss (±SD) was 1.2 ± 1.6 ml (ranging from 0 to 5 ml) in the Ligasure group (group 2) versus 22.2 ± 6.58 ml (ranging from 15 to 35 ml) in the conventional group (group 1) (P = 0.0001). The mean operative time in minutes in the Ligasure group was 6.6 ± 4.3 (ranging from 5 to 10 min) versus 21.7 ± 4.3 in the conventional group (ranging from 15 to 26 min) (P < 0.001). There was significant difference in postoperative pain scores and analgesic requirement especially in the first week. Wound healing was excellent in the Ligasure group. There was no difference between the two groups in terms of degree of patient satisfaction and number of postoperative complications.
Ligasure is an effective instrument for hemorrhoidectomy, which results in lower volume of blood loss, less postoperative pain, quicker wound healing, and earlier return to work.
Keywords: Hemorrhoidectomy, hemorrhoids, Ligasure, Milligan-Morgan
|How to cite this article:|
El Sebaei OI, El Sisi AA, Amar MS, El Sayed ME. Randomized comparative study of Ligasure versus conventional (Milligan-Morgan) hemorrhoidectomy. Menoufia Med J 2015;28:27-33
|How to cite this URL:|
El Sebaei OI, El Sisi AA, Amar MS, El Sayed ME. Randomized comparative study of Ligasure versus conventional (Milligan-Morgan) hemorrhoidectomy. Menoufia Med J [serial online] 2015 [cited 2020 Feb 28];28:27-33. Available from: http://www.mmj.eg.net/text.asp?2015/28/1/27/155930
| Introduction|| |
Hemorrhoidal disease is one of the most common anorectal disorders, affecting, in various forms, almost 50% of people over the age of 50 years, and is one of the surgical problems to which there is still no unanimity of opinion as to the best form of surgery .
The most important aspect in the diagnosis of hemorrhoids is to exclude other more life-threatening conditions and bleeding from the rectum .
Symptomatic hemorrhoids are no longer as agonizing as before because of the new modalities of operation that require shorter hospital stay and allowing patients to return to work earlier .
Throughout the years, several modifications have been made to the original operation of excision of hemorrhoids using scissors to improve outcomes, especially postoperative pain. The Milligan-Morgan open hemorrhoidectomy is the most widely practiced technique and is considered by many to be the current standard for surgical management of hemorrhoids . This traditional approach is effective; however, it is often accompanied by a high incidence of complications, such as urinary retention, hemorrhage, and significant pain .
Recent advances in instrumental technology, including the use of a bipolar electrothermal device, ultrasound scalpel, and circular stapler, are gaining popularity as effective alternatives in hemorrhoidectomy ,.
On another front, Wang et al. (2007) recently demonstrated that Ligasure hemorrhoidectomy with submucosal dissection is a fast, safe, and excellent surgical modality for achieving bloodless dissection of the hemorrhoidal cushions with a smaller complication rate. Compared with conventional hemorrhoidectomy, the Ligasure 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 Ligasure system would facilitate earlier hospital discharge and earlier return to normal work or activities .
| Patients and methods|| |
This study was carried out on 20 patients admitted to the Department of Surgery, Faculty of Medicine, Menoufia University, and Prof. Dr Ahmed Shafik's Hospital, with the diagnosis of third-degree and fourth-degree hemorrhoids.
The 20 patients were divided into two groups:
- Ten patients underwent conventional (Milligan-Morgan) hemorrhoidectomy.
- Ten patients underwent Ligasure hemorrhoidectomy.
All patients were subjected to preoperative, operative, and postoperative assessment:
- Preoperative assessment: the preoperative assessment included full history taking, clinical examination, which included general examination of the chest, heart, and abdomen, and local examination (per rectal examination) for detection of hemorrhoids, its grading, complications, and presence of other associated anorectal diseases. The patients were prepared with evacuation enema the night before surgery.
- Operative: the operations were performed on the patients under spinal anesthesia and in lithotomy position as follows: group 1: conventional hemorrhoidectomy; and group 2: Ligasure hemorrhoidectomy. Operative time and blood loss were recorded in each case.
- Postoperative: patients were followed up weekly for 2 months and then monthly for 6 months. Early postoperative follow-up (1 week) included evaluation of postoperative pain - pain score was evaluated by means of the visual analogue scale from 0 to 10, 24 h postoperatively - analgesic requirement, bleeding, and urine retention. Late follow-up of the patient for 6 months included studying complete healing time, discharge, anal stenosis, incontinence, recurrence, and patient satisfaction.
| Results|| |
Operative time: the operative time was significantly shorter in the Ligasure group; the mean (±SD) operative time was 6.6 ± 4.3 min (ranging from 5 to 10 min), compared with 21.7 ± 4.3 min (ranging from 15 to 26 min) for the conventional group (P < 0.001) [Table 1].
Operative blood loss: intraoperative blood loss was estimated by the number and degree of soaking of the gauze and by comparing the weight of the gauze before and after the operation. The Ligasure group showed significantly lower intraoperative blood loss; the mean (±SD) was 1.2 ± 1.6 ml (ranging from 0 to 5 ml) compared with 22.2 ± 6.58 ml (ranging from 15 to 35 ml) for the conventional group (P = 0.001) [Table 2].
|Table 2: Distribution of the studied groups regarding amount of blood loss|
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Pain : patients in the Ligasure group achieved a significantly lower pain score on the first day, seventh day, and second postoperative week compared with the conventional group.
The mean (±SD) pain score in the Ligasure group on the first day was 5.4 ± 1.73 (ranging from 2 to 9) versus 7.0 ± 1.72 (ranging from 4 to 10) in the conventional group (P = 0.006). On the seventh day the mean (±SD) pain score in the Ligasure group was 1.7 ± 0.86 (ranging from 0 to 3) versus 2.5 ± 1.05 (ranging from 1 to 4) in the conventional group (P = 0.012), and on the second postoperative week the mean (±SD) pain score in the Ligasure group was 0.3 ± 0.47 (ranging from 0 to 1) versus 1.0 ± 0.64 (ranging from 0 to 2) in the conventional group (P = 0.001) [Table 3].
Analgesic requirement: with respect to the type of analgesics required during the first postoperative day, all patients in the Ligasure group required NSAIDs in the form of diclofenac sodium (75 mg intramuscularly). Six patients received a single dose and four patients received two doses; no further doses were required to relieve the pain except in one patient (10%) who required a more potent analgesic in the form of pethidine (1 mg/kg single dose).
In the conventional group, all patients required NSAIDs in the same form and at the same dose as mentioned above. Three patients received a single dose and seven received two doses; however, five patients required more potent analgesic in the form of pethidine at the same dose as mentioned above.
Conclusively, there was significant difference between the Ligasure and conventional groups with respect to analgesic requirements; the Ligasure group required less amount of analgesics compared with the conventional group (P = 0.006) [Table 4].
|Table 4: Comparison between the studied groups regarding analgesic requirements|
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The amount of analgesics required was less after the first 24 h, but the Ligasure group showed less analgesic requirement than the conventional group at all late time intervals [Table 4].
Postoperative bleeding: there was one case (10%) of postoperative bleeding in the conventional group that occurred on the seventh postoperative day; the bleeding was minimal and was controlled with hemostatics and antibiotics. However, postoperative bleeding did not occur in the Ligasure group (P = 0.15) [Table 5].
|Table 5: Comparison between the studied groups regarding postoperative complications|
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Urinary retention: in the Ligasure group there was one case (10%) of postoperative urinary retention, whereas in the conventional group there were three cases (30%) (P = 0.15) [Table 5].
Discharge: the Ligasure group had five patients (50%) with postoperative discharge, in contrast to the conventional group, which had nine patients (90%) (P = 0.001) [Table 5].
The discharge in both groups was bloody at first and then mucoid, except for one patient in each group in whom the discharge turned purulent because of infection, which was controlled with antibiotics.
Stenosis: the Ligasure group had no patients (0%) with stenosis, whereas in the conventional group there was one patient (10%) with stenosis (P = 0.15) [Table 5].
The case of stenosis in the conventional group occurred in the sixth postoperative week and was managed with anoplasty.
Incontinence: the Ligasure group had no patients (0%) with incontinence, whereas in the conventional group there was one patient (10%) with incontinence (P = 0.15) [Table 7]. The patient with incontinence in the conventional group complained of incontinence due to flatus, which resolved within 4 weeks and did not require treatment.
Wound swelling on the second postoperative day: the Ligasure group had one patient (10%) with postoperative wound swelling, compared with the conventional group, which had five patients (50%) (P = 0.001) [Table 5].
Time of wound healing: wound healing was faster in the Ligasure group: mean (±SD) was 4.4 ± 0.68 weeks (ranging from 4 to 6 weeks), versus 6.4 ± 0.99 weeks (ranging from 5 to 8 weeks) in the conventional group (P = 0.0001) [Table 6].
|Table 6: Comparison of the studied groups regarding time of wound healing|
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Patient satisfaction analysis
There was significantly higher patient satisfaction at 3 months postoperatively in the Ligasure group. The mean (±SD) satisfaction score in the Ligasure group in the third postoperative month was 8.7 ± 1.67 (ranging from 7 to 10), versus 7.12 ± 1.31 (ranging from 4 to 10) in the conventional group (P = 0.036).
Although there were no significant differences between the two groups in the sixth postoperative month, the mean (±SD) satisfaction score in the Ligasure group was 9.2 ± 1.26 (ranging from 9 to 10), versus 8.91 ± 1.14 (ranging from 8 to 10) in the conventional group (P = 0.11) [Table 7].
| Discussion|| |
Hemorrhoids are part of a normal human anatomy. It is a common disease affecting 5% of the general population, and it has been estimated that 50% of people over 50 years of age have complaints related to hemorrhoids .
Hemorrhoidectomy remains the most effective and definitive treatment of choice for prolapsed hemorrhoids. However, postoperative pain is the most dreaded aftermath for patients undergoing the procedure. Therefore, various new treatment modalities have been developed recently with the aim of overcoming postoperative pain. None is clearly superior to the other, and the primary concern remains reduction of postoperative pain and operative time .
Various techniques and modifications have been introduced with the aim of overcoming postoperative pain, including modification to procedures, introduction of various surgical instruments, use of preoperative lactulose and metronidazole, and the addition of lateral sphencterotomy. None, however, seems to influence postoperative pain .
The Ligasure vessel-sealing system seems to be ideal for hemorrhoidectomy as it offers a combination of excellent localized coagulation and minimal collateral thermal spread of only 2 mm, thus allowing fast bloodless dissection with minimal collateral damage. The present study confirmed this and showed, as other studies have, that the superiority of Ligasure hemorrhoidectomy over Milligan-Morgan's hemorrhoidectomy consists in significantly reduced operative time, reduced postoperative pain, and reduced amount of parenteral analgesics required .
This study was conducted to compare the results of Ligasure hemorrhoidectomy with conventional (Milligan-Morgan) hemorrhoidectomy.
In our study there was no significant difference between the two groups with respect to preoperative data. Therefore, correlation between the two groups could reflect the actual difference between the two groups.
As regards operative time, this study found a highly significant shorter operative time in the Ligasure group compared with the conventional group: mean (±SD) was 6.6. ± 2.1 min (ranging from 4 to 10 min) versus 21.7 ± 4.3 min (ranging from 15 to 27 min) (P = 0.0001) ,,,.
The shorter operative time in Ligasure hemorrhoidectomy could be related to the better hemostatic control and lack of any need to ligate the pedicles, and the almost absolute bloodlessness in the operative field as a result of which no time is required to secure hemostasis .
Strikingly, this study found significant difference between intraoperative blood loss in the two groups. The Ligasure group showed mean (±SD) intraoperative blood loss of 1.2 ± 1.6 ml (ranging from 1 to 5 ml) compared with 22.2 ± 6.5 ml (ranging from 15 to 35 ml) in the conventional group ,, in contrast with the study by Johnson , who reported no measurable blood loss in Ligasure hemorrhoidectomy.
The significantly lower intraoperative blood loss in Ligasure hemorrhoidectomy may be explained by the effective hemostatic control achieved by the use of Ligasure device.
Significantly in the Ligasure group, patients achieved lower pain score on the first day, seventh day, and second postoperative week (P < 0.01) compared with the conventional group ,,.
Meanwhile, Chung and Wu reported significant reduction in postoperative pain in the Ligasure group on the first and second day and no significant difference on the seventh and 14th day postoperatively .
Jayne et al.  found that there was lower pain score on the first day in the Ligasure group, although this was not statistically significant; also Palazzo et al.  reported that their study failed to demonstrate any reduction in postoperative pain between the Ligasure and conventional groups.
The significant lower postoperative pain score encountered with Ligasure hemorrhoidectomy compared with conventional hemorrhoidectomy could be attributed to the fact that the Ligasure system seals tissue bundles without dissection, which causes minimal lateral thermal injury and reduces sticking and tissue charring .
The absence of sutures transfixing vascular pedicles could be another additional advantage in reducing pain: it avoids the development of local ischemia and necrosis that might cause acute postoperative pain and secondary bleeding .
Complementary to the postoperative pain status, the analgesic requirement in the Ligasure group was lower than that of the conventional group [11,16], in contrast with the results of Jayne et al. , who declared that there was no difference in analgesic requirement between the two groups. This difference is logical because of the difference in the severity of pain score between the two groups .
It is noteworthy that a single case (10%) in the conventional group developed secondary hemorrhage on the seventh postoperative day, which was managed conservatively (hemostatics and antibiotics) ,,.
Mostly related to the severity of postoperative pain, three cases (30%) in the conventional group and one case (10%) in the Ligasure group developed acute postoperative urinary retention but the difference was not statistically significant; all cases were managed by bladder catheterization ,,,,.
Postoperative wound discharge was found to be significantly lower in the Ligasure group (five cases = 50%) compared with the conventional group (nine cases = 90%) ,.
The lower degree of discharge in the Ligasure group could be attributed to limited tissue injury, which reduced wound sepsis and facilitated healing .
In our study there were no cases of anal stenosis in the Ligasure group, as reported by Wang and colleagues ,,,,. The incidence of stenosis after Ligasure hemorrhoidectomy was 2 and 2.4%, respectively.
However, there was one case (10%) in the conventional group that occurred 6 weeks postoperatively and was managed with anoplasty ,,.
Anal spasm after hemorrhoidectomy has been implicated in postoperative pain and poor wound healing. It has been postulated that Ligasure hemorrhoidectomy is associated with reduced anal spasm because the collateral damage with Ligasure is less compared with diathermy in conventional hemorrhoidectomy .
Postoperative fecal incontinence occurred in one case (10%) in the conventional group (to flatus only and resolved within 4 weeks) , in contrast to other studies, which found no cases of fecal incontinence after conventional hemorrhoidectomy ,,,.
There were no cases of fecal incontinence in the Ligasure group and this was in line with the results of Gearhart and colleagues ,,, who found that there were no cases of fecal incontinence after Ligasure hemorrhoidectomy. In contrast, others reported that the incidence of fecal incontinence after Ligasure hemorrhoidectomy was 15%  and 4.5% .
This could be attributed to the sphincter stretching during conventional hemorrhoidectomy. This component of sphincter injury is minimized by the Ligasure technique . Moreover, in conventional hemorrhoidectomy the incorporation of underlying sphincter muscle in the hemorrhoidal excision and the postoperative inflammatory healing process play a role in postoperative incontinence. In addition, there is transient reduction in anal sensation up to 6 weeks after conventional hemorrhoidectomy because of removal of the sensory bearing anal canal mucosa .
Significantly, postoperative follow-up revealed wound swelling on the seventh postoperative day in a single patient (10%) in the Ligasure group compared with five patients (50%) in the conventional group. In contrast  found no significant difference between the two groups.
Similarly, the Ligasure group achieved faster wound healing (4.4 ± 0.68 weeks), compared with the conventional group (6.4 ± 0.994 weeks), as observed by Basdanis et al.  after Ligasure hemorrhoidectomy and by Peters et al.  after conventional hemorrhoidectomy, but Wang and colleagues , reported that there was insignificant difference between the two groups.
Reduced anal spasm and the smaller size of surgical wounds associated with Ligasure hemorrhoidectomy may have contributed to the significantly earlier wound healing observed after Ligasure hemorrhoidectomy compared with conventional hemorrhoidectomy. Complete wound healing was achieved in 80% of patients by 4 weeks and reached 100% by 6 weeks, whereas after conventional hemorrhoidectomy 60% of patients achieved healing by 4 weeks and it was only after 8 weeks that the wounds of all patients were completely healed. In accordance with our findings, Tan et al.  reported that by 4 weeks after surgery 95% of Ligasure hemorrhoidectomy wounds had healed completely compared with 76% of conventional hemorrhoidectomy wounds.
Combining Ligasure hemorrhoidectomy with topical glyceryl trinitrate may further improve the wound healing rates .
In our study there was no significant difference between the two groups in terms of recurrence as there were no cases of recurrence in either group, as reported by . In addition, Wang and colleagues , also reported that there were no cases of recurrence after conventional hemorrhoidectomy.
In our study there was significantly higher patient satisfaction 3 months postoperatively in the Ligasure group, in line with Jayne et al. , but they also reported that the difference was statistically insignificant.
The present study showed that return to work and normal activities was significantly faster after Ligasure hemorrhoidectomy than after conventional hemorrhoidectomy owing to reduced postoperative pain and faster wound healing. This, in addition to reduced operative time, may compensate for the higher cost of the Ligasure electrodes .
The minimal complications reported here, after a follow-up period of 6 months, suggest that Ligasure hemorrhoidectomy is a safe procedure. There were no significant differences in the incidence of complications between Ligasure hemorrhoidectomy and conventional hemorrhoidectomy except for delayed wound healing, which was significantly higher after conventional hemorrhoidectomy. Similar findings were reported by Peters and colleagues ,.
The better satisfaction after Ligasure hemorrhoidectomy may be attributed to lower postoperative pain and complications compared with conventional hemorrhoidectomy.
| Conclusion|| |
Ligasure hemorrhoidectomy is safe, effective, associated with lower pain, and fewer postoperative complications than is conventional hemorrhoidectomy; moreover, it preserves the internal anal sphincter thickness and anal canal pressures; this feature makes it the preferred modality in patients with prolapsing piles in whom sphincter function has been compromised by previous anal surgery or obstetric trauma.
Cost is the most important drawback of Ligasure hemorrhoidectomy, but we believe that this is balanced by the shorter operative time, smooth postoperative period, and lower incidence of complications.
Long-term results and recurrence rates should be further evaluated in a study with a large number of patients by comparing Ligasure hemorrhoidectomy with conventional hemorrhoidectomy.
| Acknowledgements|| |
Conflicts of interest
There are no conflicts of interests.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]