Introduction
Hysterectomy is considered the most common gynecological operation worldwide as it is done for 30% of women during their lifetime. (1-5) The operative site for hysterectomy can be abdominal, vaginal or laparoscopic.
Abdominal hysterectomy has the
advantage of good intra-operative field, but the disadvantages are an abdominal wall scar and the long time for recovery.(6,7) Vaginal hysterectomy was first operated by Lagenbeck in 1813, since that time it had gained some popularity for both benign gynecological
conditions and for uterovaginal prolapse.(8)
The advantages of vaginal hysterectomy include less perioperative morbidity,
shorter hospitalization, and early return to normal activity.(6) Despite these advantages of vaginal hysterectomy, only
one third of hysterectomies are done vaginally because of the limited surgical planes for securing the vascular pedicles(3,4,6) and the risk for bladder injury.(9)
Vascular pedicles during hysterectomy can be secured using usual mechanical ways (sutures, clips or staples), or by vessel coagulation (high frequency
electocautery, ultrasound or laser).(10,11) To replace the usual methods of hemostasis, the ligasure vessel sealing
apparatus was launched by Valleylab (Boulder, CO, USA).(2,12)
It is operated by recognizing the type of tissue to pass the
right dose of pressure and energy. This dose alters the collagen and elastin in the vessels to be sealed with minimal lateral thermal injury. (2,6,11,12)
Ligasure is becoming more popular in many operative procedures as thyroidectomy, splenectomy, and urology procedures.(12)
It is more suitable for difficult operative cases because it can abandon the need for vessel traction and the shorter time needed for hemostasis. (1,6,10) The efficacy of ligasure in gynecological procedures was found to be comparable to clips and ultrasound vessel
sealing.(10)
The Ligasure Vessel Sealing System (LVSS) was developed for sealing vessels and tissue bundles up to 7mm in diameter by using a controlled high power
current at low voltage to melt the tissue’s collagen and elastin. This technique is associated with reduced thermal spread in comparison with unipolar
cautery.(1-13,14)
Previous studies found that employing the LVSS in thyroid surgery is easy that a surgeon is able to acquire it
within the first operation. It is also safe as complications are minimal.(15) LVSS is relatively faster compared with suture ligation
as the current delivered to achieve haemostasis takes between 2 and 7 seconds.(6)
The purpose of the current study is to compare the efficiency of ligasure vessel sealing system with conventional sutures ligation method in vaginal
hysterectomy using different parameters: the operating time, operative blood loss, hemoglobin level, the hospitalization, and the intra-operative and
immediate postoperative complications.
Method
This randomized clinical trial (RCT) was conducted between March 2010 and May 2012 in King Hussein Medical Centre. It was approved by the Ethical Committee of Jordanian Royal Medical Services after providing a proposal which included the
title of the study, literature review, the objectives, the significance, the methodology, the procedures of maintaining confidentiality, and the
risks/benefits. A total of 100 patients participated in this study. Ligasure method was used for 52 patients and conventional suture method was used
for 48 patients.
Simple randomization was the procedure of randomizing the participants of the study. Patients awaiting hysterectomy were prospectively randomized.
Approximately 25 appointments for hysterectomy were available every six months during the time of the study. The patients were indicated for vaginal
hysterectomy due to benign gynecological problem (dysfunctional uterine bleeding, and myoma) and uterovaginal prolapse.
The patients who had previous
pelvic surgery, pelvic inflammatory disease, endometriosis, uterine size more than twelve weeks, and genital malignancy were excluded from the study.
The investigator called each eligible patient to inquire if she was willing to participate in the project after giving her full information about the
study orally on the phone. Such information included details about the purpose of the study, the procedures, and the significance. Out of 103 eligible
patients who were called, 100 patients gave verbal approval to participate (Fig.1).
The patients were assigned identification numbers to ensure confidentiality. These numbers were entered into International Business Machines
Corporation Statistical Product and Service Solutions (IBM SPSS) software. Ligasure procedure was coded as number 1 and conventional suture ligation
was coded as number 2. Random number generator was run for simple randomization to either using the Ligasure
procedure or conventional suture ligation during vaginal hysterectomy.
This method of randomization prevented the selection bias in allocating
the patients to two different procedures of treatment. Before the
surgery, the participants signed the consent form and they had the right
to withdraw from participating in the study at any time. The same
surgeon operated all surgeries. The surgeon and the patients were
blinded to the method of surger.
The mean of follow-up was four months. The basic characteristics of the patients in ligasure and conventional groups were
similar, including mean of age 47 and 49 respectively as presented in Table I. There was no significant statistical difference regarding parity,
height, weight, and BMI in both groups.
Independent sample t-tests were run to compare ligasure group and conventional suture group using different parameters. In the ligasure group, the
operative time for vaginal hysterectomy was significantly shorter than the conventional suture group. The operative blood loss and drop of hemoglobin
were significantly lower in the ligasure group than the conventional group.
Regarding hospitalization, the number of days for staying in the hospital
for ligasure group was significantly less than the conventional suture group. These results are shown in Table II.No significant difference was found
between the two groups in major intra-operative complications.
For example, there were no cases of blood vessels injury, ureteric injury, rectal
injury, vulvar burns, or the need for laparotomy for operative difficulties or uncontrolled bleeding in both groups. There was only one case of bladder
injury and two cases of soft tissue hematomas in the conventional sutures group.
The immediate post-operative period was assessed for complications including the pain scores using a visual analogue score from 0-10. Pried sample
t-test results indicated a statistically significant lower score in ligasure group compared with conventional sutures group, the p value, and t value
were equal 0.03, and 5.5, respectively.
The mean of pain score in the conventional suture group was 6 in the comparison with the mean of 4 for the
ligasure group. No cases were reported for wound infection and blood transfusion in both groups. There was only one case with fever and one case of
urinary tract infection (UTI) in the conventional suture group.
Discussion
Hysterectomy is a major gynaecological procedure, which is indicated in cases of abnormal uterine bleeding, uterine fibroid or genital prolapse. (3,16) Vaginal hysterectomy is preferred over abdominal hysterectomy because of less perioperative morbidity and quicker
recovery and return to normal activities.(4,16)
Also, nowadays combining oophorectomy with vaginal hysterectomy by
experienced surgeons makes it a good alternative surgical procedure with lower risk of morbidity especially in the absence of uterine prolapse. (6,10) Ligasure sealing system makes the surgical field more accessible which may be reflected on increasing the
indications of vaginal hysterectomy.(21)
Gynecologists are looking for less invasive and more effective operative techniques using the vaginal route.(10,17)
Ligasure vessel sealing system has the advantage of reducing the blood loss and achieving safe method of vessel sealing with lower rate of morbidity
compared to conventional sutures in vaginal hysterectomy.(10,18) It is also important to have shorter operation time and to reduce
the use of conventional sutures as these will lower the morbidity and the cost of the operation.(19)
Performing vaginal hysterectomy needs experience and training especially in the absence of prolapse and for the ligation of the main vessels.(10) In some studies vaginal hysterectomy was the main procedure in around 95% of benign gynaecological conditions.(1)
With this wide spread use of vaginal route for hysterectomy, it is necessary to have the suitable instruments to
encourage more surgeons to practice vaginal hysterectomy.(1) Ligasure unit is a blood vessel sealing system that can handle blood
vessel up to 7 mm in diameter and decrease the loss of blood as safe alternative to other methods.(10,20) It has been
found that the operation time, operative blood loss and hospital stay are significantly lower when operating with the ligasure vessel sealing system
and more effective compared to the conventional suturing method.(12)
It is well known that bleeding is one of the important drawbacks of hysterectomy. Using ligasure will give the surgeon a better and easier surgical
field which will be reflected on the outcome including the bleeding, duration of surgery, and thrombotic complications.(12)
The strength of vessel seal obtained by ligasure is comparable to conventional methods and better than other energy dependent modes. (21) Some studies did not show any statistical significance in reducing blood loss using ligasure method.(10,19)
The results of this study are in agreement with several previous studies(1,12,18,21,22) that showed a significantly lower
blood loss and less drop in hemoglobin in ligature group compared with conventional group.
Improving the accessibility of the surgical plane in a limited space using the ligasure is reflected on shorter operative time and no need for space for the use of needles, in addition to reducing the
risk of stings.(4,21) The results of this study also showed a significant shorter operating time for vaginal hysterectomy of the
ligasure group compared with conventional sutures group. This result is comparable to other studies that showed similar finding. (6,12)
Some previous studies(1,19,21) found that the period of hospitalization is shorter in the ligasure group compared with the
conventional sutures group. The findings of these studies support the result of the current study about hospitalization. On the other hand, some other
studies(4,16) did not show any significant difference in the hospital stay between the two groups.
Several studies showed that the complication rate of using ligasure varies from 8.0% to 16.0%.(6) There was no significant
complication regarding intra-operative and immediate post-operative period with regard to major blood vessels injury, ureteric injury, and bladder
injury. There was also no soft tissue hematoma, or a need for laparotomy for significant bleeding or vulvar burn. These results were found previously
in the literature.(6,23,24,25)
The post-operative pain is reduced after using ligasure because there is no foreign body in the form of ligature as ligasure system is giving certain
current of energy which is confined to 1.5mm from the sealed vessel, this will cause less inflammation and less chance of fibrosis in the pelvis. (12,21) Moreover, reducing the pain score enhances the possibility of early hospital discharge and reduce the operation
cost.(10)
Furthermore, ligasure will cause less tissue pressure compared with the conventional methods.(19) Significant lower post-operative pain score was found previously in the ligature group than the conventional group.(3,22) This finding matches the result of this study about pain score in ligature group compared with conventional group.
Limitations of the study
The main limitation of the study was the relatively small sample size. In order to give more valuable results, further research is needed with larger
sample size.
Conclusion
Ligasure vessel sealing system is a preferred and safe alternative method when compared with conventional sutures ligation method in vaginal
hysterectomy. It has the advantages of shorter operating time, reduced blood loss, less reduction level of hemoglobin, shorter time of hospitalization,
and lower pain score.
References
1. Levy B, Emery L.
Randomized trial of suture versus electrosurgical bipolar vessel sealing in vaginal hysterectomy.
Obstet Gynecol
2003 Jul; 102(1):147-151.
2. Hagen B, Eriksson N, Sundset M.
Randomised controlled trial of LigaSure versus conventional suture ligature for abdominal hysterectomy
. BJOG 2005 112: 968-970.
3. Kriplani A, Garg P, Sharma M, et al.
A review of total laparoscopic hysterectomy using LigaSure uterine artery-sealing device: AIIMS experience.
Adv Surg Tech A
2008; 8: 825-829.
4. Nouri K, Ott J, Demmel M, Promberger R, et al.
Bipolar vessel sealing increases operative safety in laparoscopic-assisted vaginal hysterectomy.
Arch Gynecol Obstet
2011 Jan; 283(1): 91-95.
5. Malinowski A, Pawłowska N, Wojciechowski M.The use of Thermo Stapler-bipolar vessel sealing system in vaginal hysterectomy. Ginekol Pol 2008 Dec; 79(12):850-855.
6. Hefni MA, Bhaumik J, El-Toukhy T, et al.
Safety and efficacy of using the LigaSure vessel sealing system for securing the pedicles in vaginal hysterectomy: randomised controlled trial.
BJOG
2005 Mar; 112(3):329-333.
7. Zubke W, Hornung R, Wässerer S, et al.
Bipolar coagulation with the BiClamp forceps versus conventional suture ligation: a multicenter randomized controlled trial in 175 vaginal
hysterectomy patients.
Arch Gynecol Obstet
2009 Nov; 280(5):753-756.
8. Persad PS, Narayansingh G, Roopnarinesingh S. Operative outcome following vaginal hysterectomy. West Indian Med J 1990
Jun;39(2):67-70
9. Horng SG, Huang KG, Lo TS, et al.
Bladder injury after LAVH: a prospective, randomized comparison of vaginal and laparoscopic approaches to colpotomy during LAVH.
J Am Assoc Gynecol Laparosc
2004 Feb; 11(1):42-46.
10. Gizzo S, Burul G, Di Gangia S, et al.
LigaSure vessel sealing system in vaginal hysterectomy: safety, efficacy and limitations.
Arch Gynecol Obstet
2013; Apr 27.
11. Janssen PF, Brölmann HA, van Kesteren PJ, et al.
Perioperative outcomes using LigaSure™ compared to conventional bipolar instruments in laparoscopic salpingo-oophorectomy: a randomized controlled
trial.
Surg Endosc
2012; Apr 27.
12. Ding Z, Wable M, Rane AJ. Use of Ligasure bipolar diathermy system in vaginal hysterectomy. Obstet Gynaecol 2005
Jan; 25(1):49-51.
13. Lee WJ, Chen TC, Lai IR, et al. Randomized clinical trial of Ligasure trademark versus conventional surgery for extended gastric
cancer resection. Br J Surg 2003; 90:1493-1496.
14. Jayne DG, Botterill I, Ambrose NS, et al. randomized clinical trial of LigasureTM versus conventional diathermy for
day-care haemorrhoidectomy. Br J Surg 2002; 89:428-432.
15. Lepner U, Vaasna T. Ligasure vessel sealing system versus conventional vessel ligation in thyroidectomy. Scand. J Surg 2007;
96:31-34.
16. Samulak D, Wilczak M, Michalska MM, et al.
Vaginal hysterectomy with bipolar coagulation forceps (BiClamp) as an alternative to the conventional technique.
Arch Gynecol Obstet
2011 Jul; 284(1):145-149.
17. Mistrangelo E, Febo G, Ferrero B, et al.
Safety and efficacy of vaginal hysterectomy in the large uterus with the LigaSure bipolar diathermy system.
Am J Obstet Gynecol
2008 Nov; 199(5): 475.e1-5.
18. Tamussino K, Afschar P, Reuss J, et al.Electrosurgical bipolar vessel sealing for radical abdominal hysterectomy. Gynecol Oncol 2005 Feb; 96(2):320-322.
19. Cronjé HS, de Coning EC. Electrosurgical bipolar vessel sealing during vaginal hysterectomy. Int J Gynaecol Obstet.
2005 Dec; 91(3):243-5. Epub 2005 Oct 21.
20. Elhao M, Abdallah K, El-Laithy M, et al. Efficacy of using eclectrosurgical bipolar vessel sealing during vaginal hysterectomy in
patients with different degrees of operative difficulty: A randomized controlled trial. Eur J Obstet Gynecol Reprod Boil 2009; 147(1):86-89.
21. Agnaldo L, Silva-Filho AL, Rodrigues AM, et al.
Randomized study of bipolar vessel sealing system versus conventional suture ligature for vaginal hysterectomy.
Eur J Obstet Gynecol Reprod Biol
2009 Oct; 146(2): 200-203.
22. Aytan H, Nazik H, Narin R, et al. Comparison of the Use of LigaSure, Halo PKS cutting forceps and EnSeal tissue sealer in total
laparoscopic hysterectomy: A randomized tria. JMIG 2014; 21(4): 650-655.
23. Garry R, Fountain J, Mason SU, et al. The eVALuate study: two parallel randomized trials, one comparing laparoscopic with abdominal
hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. BMJ 2004: 328(7432):129.
24. Makinen J, Johansson J, Tomas C, et al. Morbidity of 10110 hysterectomies by type of approach. Hum Reprod 2001:16(7):1473-1478
25. Marresh MJA, Metcalfe MA, Mc Pherson K, et al. The Value national hysterectomy study: Description of the patients and their surgery. Br J Obstet Gynecol 2002:109:302-312.