Università degli Studi di Roma
“Sapienza”
Dottorato
“Tecnologie avanzate in chirurgia”
Caiman® versus LigaSure™
Hemorrhoidectomy: postoperative pain, early
complications and long term follow-up. A
pilot study
Relatore Dottoranda
Prof. Domenico Mascagni Dott.ssa Chiara Eberspacher
Introduction
Hemorrhoids are one of the most common anal disease, with symptoms like bleeding, pain and a mass protrusion that can worsen the quality of life in a significant way. Despite the diffusion, the ideal treatment for hemorrhoids is still object of debate and studies (1,2), especially with the introduction of new devices for coagulation and sealing. Moreover there are different techniques and choosing of the right one depends on symptoms and classification of hemorrhoids. For Grades I or II hemorrhoids, according the Goligher’s classification, it is often adopted a conservative approach with diet, changes in life style, medical therapy and in some cases rubber band ligation or sclerotherapy. For Grades III or IV hemorrhoids it is totally different: there is the possibility to use many different techniques such as hemorrhoidectomy, (“open” Milligan Morgan technique - or “close” Ferguson’s), stapled
hemmorhoidopexy, Transanal Hemorrhoids
According literature Milligan Morgan hemorrhoidectomy is still the most common and effective technique (4) used for symptomatic Grades III or IV hemorrhoids. At the same time it presents many complications (such as postoperative pain, a great discomfort for the patients, soiling, in some cases bleeding, …) that deviate from the ideal technique and represent the reason why patients refuse this operation. There are also some late complications such as anal stenosis, anal fissures and recurrences that have to be evaluated in a long-term follow-up.
The most common problem, the postoperative pain, is due to the tissue damage and inflammatory response during excision of piles with the use of diathermic energy. The burn injury is not limited to the area of the wounds, but affects close areas where there are mucosal bridges. It influences also wound healing time.
To minimize this effect there was the diffusion, in the last years, of different devices that use new types of energy to coagulate and seal vessels, reducing operative time, the necessity of stiches and the dispersion of energy on the
surrounding tissue. LigaSure™ Vessel Sealing System and Caiman® are two of these tools based on radiofrequency, in a combination of pressure and energy, using the own body’s collagen and elastin to create a permanent fusion zone. Both can close the vascular structures up to 7 mm fully and permanently, with minimal surrounding thermal spread and limited tissue charring. They make easier a bloodless excision of hemorrhoids without legation or stiches, and minimizing the tissue trauma.
LigaSure™ - Small Jaw Open - has a working length of 18,8 cm, an average seal cycle of 2-4 seconds, a seal length of 16,5 mm, a cut length of 14,7 mm, a cutting independent from sealing. The compression of the tissue is not uniform. It is designed for operation with surgeon’s hand very close to operation’s field, with a narrow range.
Caiman® 5 born for abdominal surgery, it has a working length of 24 cm, a seal length of 26,5 mm, a cut length of 23,5 mm, an uniform tissue compression (differently form Ligasure™). It is less maneuverable in a narrow operation field, but it is articulable.
Several studies have compared the effectiveness of LigaSure™ with the diathermic hemorrhoidectomy in terms of operative time, postoperative pain, bleeding, time of recovery, also in order to justify the increased cost of the operation with these disposable devices. A clear trend suggests a minor postoperative pain and a faster healing time and recovery with the use of this tool. Despite its effectiveness, LigaSure™ has a high cost that make some surgeons reluctant in the use of this instrument.
Our question is “have we to use only this dedicated device, designed for proctology and that uses radiofrequency, or can we obtain same results with other radiofrequency devices, less expensive?”
We investigated differences in terms of operative time, bleeding, soling, outcomes and late complications between these two devices that uses radiofrequency for modified Milligan Morgan hemorrhoidectomy. At the end we made some considerations in term of costs, thinking about large amount of studies about use of LigaSure™ in the proctology, even with its high cost, differently from
Caiman®, whose used it is confined to abdominal surgery, even if cheaper.
Fig. 1
Radiofrequency hemorroidectomy: before and after excision of three piles (Milligan Morgan technique)
Fig. 2
Initial dissection with monopolar scissor and separation of the hemorrhoid from internal anal sphincter’s fibers
Fig. 3
Excision with LigaSure™: the tool is very maneuverable because of its lengh
Fig. 4
Preservation of mucosal bridge with minimum damage and the evidence of internal anal sphincter’s fiber
Fig. 5
Length of Caiman and distance between surgeon’s hand and operation field
Materials and Methods
Between January 2015 and December 2017 patients with symptomatic Grades III or IV hemorrhoids were selected, in our unit of Abdominal Surgery and Proctology. Informed consent has been obtained from all. The inclusion criteria were male or female patients, over the age of 18 years, with symptomatic Grades III or IV hemorrhoids and the necessity of a “full” hemorrhoidectomy with not only one pile removed. Exclusion criteria were: the association with other anorectal disease (anal fissure, fistula,…), obstructed defecation syndrome, inflammatory bowel disease, previous anorectal surgery, chronic therapy with anti-inflammatory drugs. All patients enrolled, received
Caiman® hemorrhoidectomy or LigaSure™
hemorrhoidectomy. The two Groups were homogenous for age, sex, average number of piles excised and for all the baseline characteristics (Table 1).
Patients included in the study underwent hemorrhoidectomy by the same surgical team, with the Milligan Morgan’s technique.
All the patients over 50 years were submitted colonoscopy to rule out colorectal polyps/cancer according our screening program. All were treated preoperatively with a cleansing enema and during the operation, performed in lithotomic position, was administrated Ciprofloxacin 200 mg. Anus was dilated with Eisenhammer retractor: all the piles were separared from skin with an initial incision with monopolar scapel. When the plane on the internal sphincter was revealed, hemorrhoidectomy was completed or with Ligasure™ or with Caiman®, without any pedicles ligature or stitches. A Tabotamp® was left in the anal canal and removed the same evening or the day after. All the operation were performed or with epidural or general anesthesia, and a local anesthesia with Mepivacain 2% was given to all.
In the postoperative time for the first five days patients were administrated 1000 mg Paracetamol three times a day,
with in addition in case of strong pain Metamizole 500mg/ml XV or XX drops according the weight and the pain. After the first five days they took only Paracetamol 1000mg, a tablet in case of pain. All the patients were discharged with stool softeners and diet prescriptions for 30 days after the operation.
They were checked at one week after operation, four weeks, and then after 2, 6, 12 months, always with a clinical control with rectal digital examination by two expert members of the equipe (DM and CE) and a questionnaire about pain, other symptoms, quality of defecation and overall satisfaction. The long-term follow-up was extended with phone calls for an average period of 18 months after the operation.
We took in considerations many factors: intraoperative (operative time, number of piles removed, necessity of stiches or ligation), immediate postoperative (pain, bleeding within 4 weeks , incontinence, soiling within 4 weeks, healing time of anal wounds, return to working activities), and a long term follow up (necessity to apply a dilator to
avoid or cure anal stenosis, fissures, recurrences, overall satisfaction).
Primary end point was postoperative pain evaluated with Visual Analog Score, ranged from 0 to 10, 10 being the most painful. Pain was investigated after one, after 2 and after 4 postoperative weeks. In the same time lapse we reported episodes of incontinence, flatus and the sensation of wetness with soiling, evaluated with the mean secretion time. Bleeding was reported both as an immediate complication during hospitalization or in the first postoperative weeks. Patients’ satisfaction also ranged from 0 to 10, 10 being the most satisfactory. The presences of recurrences was also objectified by clinical examination by the expert members of the team (DM and CE), also after the end of clinical follow-up of 1 year. We considered also the anal stenosis, but not strictly: according our internal protocol to avoid this complication in an early period, in the subjects with chronic pain and initial narrow healing, we teach them to practice a self-mechanical dilation with a Dilator. So we analyzed in how many patients after four
weeks we had to use dilation to minimize the risk of anal stenosis.
Data were analyzed using SPSS for Windows, version 21 (SPSS Inc., Chicago, IL, United States).
Means and standard deviations (SDs) were used to report continuous data, while numbers and percentages were calculated for all categorical data. Univariate analysis was performed by Student’s t test. A p value ≤0.05 was considered statistically significant for all analyses.
Results
A total of 35 patients were enrolled in this study in between January 2015 and December 2017: 35 in Group A (Caiman®) were matched with 35 control patients (Group B) from our historical cohort, treated with LigaSure™. Baseline data are shown in Table 1: groups were homogeneous for sex, age, number of piles excised, preoperative symptoms.
For the intraoperative data, most of patients (GA 28 vs GB 30) submitted epidural anesthesia, only a little group general anesthesia (GA7 vs GB 5). Overall mean duration of operation (GA 35 min vs GB 33 min) was similar, shorter in LigasSure™, but not for this statistically significant (p = 0,198). Also the number of patients that needed stiches to avoid intraoperative bleeding after the removal of piles with radiofrequency tools were not significantly different between the two groups (GA 20% vs GB 28,6%; p = 0,19). There were two episodes of bleeding than required a prolongation of hospital stay in Group A and four episodes in Group B (p = 0,2), one after the discharge with the necessity of a new recovery. Only one patient in Group B underwent an evaluation under anesthesia for bleeding, without the necessity of stiches or ligatures.
There were not differences between the two Groups related to postoperative pain (Table 2). LigaSure™ Group experienced less pain in the first week (I day VAS 5,4; I week VAS 2,7) compared to Caiman® Group (I day VAS
6,25; I week VAS 3,11) but without a statistic relevance (p= 0,178 and p= 0,22). After 4 weeks the VAS score was almost identical (GA1,8 vs GB 1,65).
There was neither a different significant in mean secretion time, with the sensation of wetness and the evidence of soiling (GA11,46 vs GB 10,77; p = 0,27)
Overall incidence of early and late complications (Table 3) was similar. Only one patient in Group A reported a persistent incontinence for flatus with the necessity of pelvic rehabilitation for full recovery. Heling time was comparable between Caiman® and LigaSure™ (GA15,86 vs GB16,65; p = 0,22) such as return to work (GA 11,14 vs GB11,31; p = 0,45).
During the follow-up (mean 18 months) we investigated the necessity to apply a dilation, according to our internal protocol to avoid chronic pain, and evolution in anal stenosis, presence of recurrences, and the overall satisfaction at the end of the visits. We taught to use self-mechanical anal dilation in 7 patients in Group A (20%) vs 5 Patients in Group B (14,7%), because after 4
postoperative weeks we identified a chronic pain and a stenotic healing, that could evolve in a anal stenosis in the long time. Only two patient s in the Caiman® Group within 6 postoperative months presented anal fissure, treated in efficient way with an ointment of hyaluronic acid plus silver sulfadizine.
After 15 months follow-up only a patients in Group B presented a single hemorrhoid that required excision.
Discussion
Milligan-Morgan hemorrhoidectomy is still the most performed operation for hemorrhoids, because its efficacy especially in consideration of the minimal possibility of recurrences. Despite its popularity, many patients refuse this operation for the large amount of complication, first of all postoperative pain, but also bleeding, soiling and the
common discomfort that delays the return to work or everyday activities.
From 2001, for this reason, new devices that change the type of energy used for dissection are described in literature, in order to create the ideal technique that should minimize postoperative pain and symptoms linked to bad quality of life with the maximum efficacy in term of recurrences. The use of radiofrequency instead of diathermy hemorrhoidectomy seemed to reach this goal: the fusion between collagen and elastin assures a good healing, decreasing risk of bleeding acting on medium tunic of vessels. In the same time surrounding tissues are not damaged, especially mucosal bridges that have to be preserved during the operation in order to obtain a good healing without stenosis.
Many studies have compared the conventional diathermy hemorrhoidectomy with LigaSure™ excision, several randomized, analyzing especially the different postoperative pain (9). In 2007 Altomare et Al. (5) in a prospective, randomized, multicenter trial demonstrated the
less postoperative pain associated with an early return to work in the LigaSure™ Group versus diathermy including in the study 273 patients from 15 different colorectal units. In 2008 a quantitative metanalysis (5) reported a faster wound healing in LigaSure™ hemorrhoidectomy, defined in other works as as time to absence to swelling (8). In 2011 (7) it was observed that despite less operative pain and early wound healing, there were no differences between diathermy and LigaSure™ in time of return to work, but they also put in evidence the trend of an early return to work according the different profession, in particular in the self-employed patients. They also noticed a higher rate of anal stenosis in the radiofrequency group, associated with an excessive removal of anoderma.
Many studies compared also the economic convenience of using a device with a medium price in the list of about 500 €. Metanalysis (3) justifies this cost with the overall reduction on VAS and the minor use of drugs for pain and the early return to work for patients.
If there are so many studies that affirm the superiority of radiofrequency, in particular LigaSure™ device, in terms of postoperative pain, healing time, return to work, there is nothing about other tools, especially about Caiman®, which are not expressively designed for proctology, but are less expensive. Our aim is so to verify is the first one has a true justification or the results with different devices can be stackable.
Kim et Al. (6) operated a similar comparison between Starion and Harmonic Scapel, used for grade III and IV hemorrhoids. They focalized on another type of energy and not on radiofrequency, but with our same goal: to evaluate if a device “dedicated to hemorrhoidectomy” and so more expensive is better than another not designed for this, but cheaper.
Ligasure Small Jaw Open is a device especially studied for microsurgery and seems to have found his supremacy in the proctology, in particular in hemorrhoidectomy. Its lengh of 18,8 cm makes easier to handle it and the cut length of 14,7 mm allows to divide precisely vessel structures from
anoderm. The cost of the single-use tool is about 500 €. Differently Caiman® was not studied for this region or fine dissection and the dimension of the tool is 24 cm, with the risk to increase the distance between surgeon and operation field, decreasing precision. Also the seal length of 26,5 mm is more than a centimeter plus than LigaSure™’s. It could translate in more difficulties in the operation or less precision, with not a precise dissection of the piles from the plan of internal sphincter. But the distribution of radiofrequency in the seal length is more uniform, not linked to the pressure, and it is also articulable. The cost of the single-use instrument is about 350 €.
According to our pilot study there is not a significant difference in maneuverability between the two tools: even if the mean operation time is higher in the Caiman® Group (35 min vs 33 min) there is not a difference statistically relevant (p = 0,198) and also the medium number of piles excised was the same. The necessity of stiches or pedicles’ ligatures was less frequent in Caiman® Group, maybe for
the greater length of seal arm, but always not significant (p = 0.19).
Our first conclusion is that despite the different “design” of the two model, there are not so many differences in the easiness of the operation for the surgeon, who can reach same results with efficacy.
Analyzing early postoperative complications it is different to find a device better than other. Postoperative pain that is the primary end-point is similar both in the immediate than in the late period. Surely the mean VAS is minor in Group B with LigaSure™ (Group A 6,25 vs Group B 5,4 first day; Group A 3,11 vs Group B 2,7 after 1 week) but there is not a statistical significance (p = 0,178 and p = 0,22). This difference between two mean VAS also decreases after four PO weeks. Episodes of bleeding are stackable too.
There is no difference in time to return to work (GB 11,14 days vs GB 11,31 days p = 0,45) or time for wound healing, so it is indifferent in term of social cost to use one device or another.
Among the long time follow-up in both Groups we had to tech self-anal dilation for an initial stenosis in order to avoid a future narrow healing. According the literature and our experience this element is due to the number of piles excised, that tends to be higher with the use of radiofrequency in general.
Overall satisfaction at the end of follow-up is also almost identical (Group A 8,34 vs Group B 8,42; p = 0,5).
In all the end-points that we took in consideration, there are not significant differences between these two devices. We had the same efficacy both in operation and in postoperative course. Every proctologist tends to use LigaSure™ for radiofrequency hemorrhoidectomy, but with some other tools like Caiman® everyone can perform a successful hemorrhoidectomy with a lower cost.
Conclusion
LigaSure™ is one of the most evaluable devices that works with radiofrequency and it is used in proctology, especially in hemorrhoidectomy. It is safe, accessible and its superiority compared to conventional diathermic
hemorrhoidectomy is matter of fact. The prevalence in the use of this tool is not justified thinking to all other instruments that apply this type of energy and that are less expensive. In particular in our pilot study we used Caiman®, a radiofrequency device too, not designed for proctology, but that can achieve same results in term of easiness in use, postoperative pain efficacy and postoperative complications. In consideration of the cost challenge in hospital nowadays it can be a cheaper solution, which conserves same efficacy.
The objective is increase the use not of the specific device of one pharmaceutical brand, but a type of energy such radiofrequency, to reach the goal to actually combine the most effective technique for hemorrhoids, Milligan-Morgan hemorrhoidectomy, with a percentage of postoperative complication acceptable.
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Table 1
Demographic and clinical characteristics at baseline
Group A (Caiman®) 35 pts Group B (LigaSure™) 35 pts Age
Mean (SD) Range 50,8 (15) (22 -76) 48,4 (14,1) (23-83) M F 20 15 17 18 Goligher’s grade III: IV 20:15 17:18 Table 2
Comparison of early outcomes Group A (Caiman®) 35 pts Group B (LigaSure™) 35 pts p value N° piles removed Mean (SD) 3,06 (0,66) 2,94 (0,59) p= 0,12
Operative time (min) Mean (SD) Range 35 (8,2) 20 – 55 33 (7,1) 20 – 50 p = 0,198 Pts needed stiches 20% 28,5% p = 0,19 Bleeding 2 4 p = 0,2
Pain Score at 1 PO day (VAS)
Mean (SD) 6,25(2,7)
5,4 (2,75) p = 0,178
Pain Score at 1 PO week (VAS)
Mean (SD) 3,11 (2,55) 2,7 (2,12) p = 0,22
Pain score at 4 PO weeks (VAS)
Mean (SD)
1,82 (1,72) 1,65 (1,61) p = 0,33
Secretion time
Mean (SD) 11,46 (4,54) 10,77 (5,4) p = 0,27
Wound healing (days)
Mean (SD) 15,86 (6,84) 16,65 (5,99) p = 0,22
Incontinence 1 (to flatus) 0
Return to work
Mean (SD) 11,14 (5,2) 11,31 (6,04) p = 0,45
Long term follow-up Group A (Caiman®) 35 pts Group B (LigaSure™) 35 pts p value
Necessity to apply dilation 7 (20%) 5 (14,3 %) p = 0,37
Stenosis 0 0 NS Anal fissures 2 0 NS Recurrences 0 1 NS Overall satisfaction Mean (SD) 8,34 (1,5) 8,42 (1,4) p = 0,5
