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ORIGINAL ARTICLE
Year : 2022  |  Volume : 35  |  Issue : 2  |  Page : 782-787

Sutureless versus conventional abdominal hysterectomy: a randomized controlled trial


1 Department of Obstetrics and Gynecology, Faculty of Medicine, Menoufia University, Menoufia, Egypt
2 Department of Obstetrics and Gynecology, Faculty of Medicine, Tanta University, Tanta, Egypt

Date of Submission18-Nov-2021
Date of Decision04-Dec-2021
Date of Acceptance06-Dec-2021
Date of Web Publication27-Jul-2022

Correspondence Address:
Asmaa M Khidre
Shebin Elkom, Menoufia
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/mmj.mmj_249_21

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  Abstract 


Objective
This study aimed to compare electrothermal bipolar-vessel sealing (EBVS) with the conventional suturing during the abdominal hysterectomy, as well as to compare the conventional bipolar-sealing system with the advanced one.
Background
Gynecologic surgery is frequently complicated by hemorrhage. Thus, it is mandatory to adopt adequate techniques of hemostasis during surgery.
Patients and methods
The study was conducted on 60 patients with indications for abdominal hysterectomy, they were divided equally into two groups: group I consisted of 30 patients who underwent abdominal hysterectomy with the use of the EBVS, either advanced; LigaSure (15 patients), or conventional; Seal, and group II consisted of 30 patients who underwent conventional abdominal hysterectomy. The primary outcome was the differences between the study and control group regarding the operative events and postoperative outcome, and the secondary outcome was the differences between the two subgroups of group I regarding the same parameters.
Results
The conventional hysterectomy group showed significantly higher operative time, blood loss, length of hospital stay, the days needed for returning to the usual activities, pain scores, and lower Ht (%). No significant differences were noted between both subgroups of group I, except in the day 3 pain score.
Conclusion
EBVS is an expensive but effective alternative to the conventional sutures in the abdominal hysterectomy for a benign condition. The advanced bipolar system (LigaSure) is comparable to the conventional one (Seal).

Keywords: advanced sealing device, conventional sealing device, electrothermal bipolar-vessel sealing, hemorrhage, hemostasis, hysterectomy Sutureless versus conventional abdominal hysterectomy


How to cite this article:
Eldamaty WG, Sanad ZF, Ellakwa HE, Khidre AM, El Masry YI. Sutureless versus conventional abdominal hysterectomy: a randomized controlled trial. Menoufia Med J 2022;35:782-7

How to cite this URL:
Eldamaty WG, Sanad ZF, Ellakwa HE, Khidre AM, El Masry YI. Sutureless versus conventional abdominal hysterectomy: a randomized controlled trial. Menoufia Med J [serial online] 2022 [cited 2024 Mar 29];35:782-7. Available from: http://www.mmj.eg.net/text.asp?2022/35/2/782/352173




  Introduction Top


Hysterectomy is a major gynecological operation for the removal of the uterus with or without adnexal structures for therapeutic purposes. The history of hysterectomy is long and varied. Although no significant advances have occurred in hysterectomy techniques until the 19th century, there have been earlier attempts to do so. Some hysterectomy references have been since the 5th century BC. In 1600, 26 vaginal hysterectomy cases were cataloged by Schenck of Grabenberg in Europe[1].

The electrothermal bipolar-vessel sealing (EBVS) system was investigated on animals in several studies. This system was found offering hemostasis in variable-sized arteries. Therefore, it has been increasingly used in variants' surgical procedures. The recent innovation of the EBVS systems has provided the surgeons an alternative feasible and reliable hemostatic method[2].

The EBVS system offers the ease of handling and rapid achieving of hemostasis that take away the foreign-body use that remains in the site of surgery. These advantages are achieved in open surgeries as well as in the laparoscopy[3].

This study aimed to compare the EBVS with the conventional suturing during the abdominal hysterectomy, as well as to compare the conventional bipolar-sealing system with the advanced one.


  Patients and methods Top


The study was conducted during the period from January 2019 to February 2020 after the approval of the Research Ethics Committee. Sample size was calculated through Epi-info software (version 7) based on the results of a previous pilot study to compare between the EBVS and the conventional suturing during the abdominal hysterectomy regarding surgery time, operative blood loss, hemoglobin reduction, complications, postoperative pain, the analgesics need, and the postoperative length of hospital stay. This study specified a sample size of 60 patients, with a level of statistical significance of 0.05 and power greater than 90% to detect a difference between group mean. This study included consecutive female patients aged more than 40 years old and undergoing abdominal hysterectomy as the indicated management procedure for various benign conditions, such as uterine myomas, uterine bleeding resistant to medical therapy, or endometriosis. Patients with previous abdominal surgeries that resulted in severe adhesion, those undergoing additional visceral procedures, incidentally diagnosed to have invasive cervical cancer, or those indicating hysterectomy for management of genital prolapse were excluded from the study. Informed written patient consents were obtained from each patient. The estimated sample size: 60 patients were divided equally into two groups (study and control), and the study was conducted according to the Declaration of Helsinki. Group I consisted of 30 patients who underwent abdominal hysterectomy with the use of EBVS, either advanced; LigaSure (15 patients) for vascular coagulation, sealing, and division (group IA), or conventional; Seal (15 patients) for coagulation and sealing only (group IB). Group II consisted of 30 patients who underwent conventional abdominal hysterectomy. One surgical team performed all operations. The EBVS generators used in the current work was the LigaSure vessel sealing generator with instant response technology, produced by Valleylab Irish company for vessel coagulation, sealing, and cutting, and the Seal vessel sealing generator, produced by Lamidey Noury French company for vessel coagulation and sealing only. Preoperative management: complete personal and obstetric history and comorbidy data were taken from each patient. Patients underwent dedicated clinical and pelvic examinations. Preoperative transvaginal ultrasonography was conducted to evaluate the uterine size and gross uterine pathology. The ultrasound machine used for imaging was Voluson E6 (manufactured by Medison-Kretz, Zipf, Korea-Austria). The routine preoperative laboratory investigations that included hemoglobin values and hematocrit percent were performed. The included female patients were administered perioperative thrombosis prophylaxis and a single dose of intravenous prophylactic antibiotic. Hysterectomies were conducted under general or spinal anesthesia after consultation with an anesthesiologist. Patients were located in the supine position. Vulva and perineum were disinfected with povidone–iodine solution. A Foley catheter was inserted. Surgical procedure: The abdomen had been prepared from the anterior thighs to the xiphoid process. Abdominal hysterectomy was performed through Pfannenstiel or midline incision in slight Trendelenberg position. After the abdomen was explored, a retractor had been placed, and the bowel had been packed superiorly to afford good exposure of the pelvis. The bowel was packed away and exposure to the pelvis was satisfactory, then uterine clamps were applied. In group I, the EBVS system was used for sealing coagulation and division of vessels (LigaSure in group IA) or for sealing of vessels only (Seal), while division was performed using the conventional scissors (group IB). The steps were as follows: clamping, relaxing tissue traction, and sealing were performed, and both round ligaments were divided, also, utero-ovarian, uterine vessels, and cardinal ligaments were divided. Incision of the vagina and excision of the uterus was performed. Closure of vault of the vagina. The vaginal mucosa was reapproximated with the use of continuous sutures in horizontal manner. Closure of the anterior abdominal wall was carried out in layers. Conventional clamping (group II): The same steps were carried out by the conventional clamping and suturing techniques. This was done using Kocher clamps and sterile synthetic absorbable sutures that are braided polyglactin 910 (vicryl 1), manufactured by ACE surgical supply company. All patients received intravenous diclofenac postoperatively for 1 or 2 days to manage postoperative pain. Patients started paracetamol, diclofenac, or both after the intravenous analgesics. When discharging patients from hospital, they were allowed to return to usual activities whenever they felt they can do so. Primary outcome: Differences between study and control groups regarding the operative events, including indication and duration of surgery (the time from skin incision to skin closure in minutes). Intraoperative hemorrhage, hemoglobin, and hematocrit reduction. Secondary outcome: postoperative hospital stay. Visual analog scale (VAS) pain scores. Days to resume usual activities.

Statistical analysis: data were tabulated and analyzed using Statistical Package for the Social Science (SPSS) version 22.0 (IBM, Armonk, New York, United States). Numerical data were presented as mean and SDs, while categorical data were presented as frequencies and percentages. Independent t-test and analysis of variance test were used to assess differences in numerical data, while χ2 test, Z-test for proportions, and Fisher's exact tests were used as appropriate to assess differences in categorical data. Pearson correlation test was used to correlate between numerical parameters. The result was considered statistically nonsignificant if P value greater than or equal to 0.05, statistically significant if P value less than 0.05, and statistically highly significant if P value less than 0.001.


  Results Top


In this study, the patient's mean age was 51.3 years. They had a mean BMI of 30.8 kg/m2 [Figure 1]. The patients' demographic and basal clinical data. There were no statistically significant differences among the three groups regarding the patient's age, BMI, parity, uterine longitudinal diameter, preoperative hemoglobin (g/dl), or preoperative hematocrit. Significant difference was found only in the medical comorbidities (P > 0.05) [Table 1].
Figure 1: The electrothermal bipolar-vessel sealing system was used in group IA for coagulation, sealing, and division of vessels.

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Table 1: Participants' demographic and clinical data

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Concerning the patients' surgical history, there were no statistically significant differences among the three groups regarding the number of Caesarean Section, previous abdominal surgery, the indications for hysterectomy, or the type of abdominal incision (P > 0.05). It was noted that the most common indication of hysterectomy was perimenopausal bleeding, either alone or accompanied by others (91.7% of causes) [Table 1].

The operative events and the outcome in the study patients. There was a statistically highly significant difference in the operative time among the study patients (P < 0.001), with the higher time, noted in group II (conventional hysterectomy), followed by the subgroup IB, and the least time was noted at the subgroup IA. The difference between both subgroups of group I was statistically nonsignificant (P > 0.05), the difference was about 3 min [Table 2].
Table 2: Operative events and patients' outcome

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Statistically high significant differences were noted also among the three groups in regard to the amount of blood loss, with no significant difference noted between group IA and group IB [Table 2].

The length of hospital stay and the days needed for returning to the usual activities, differed with statistically high significance among the three groups, with the highest values that were demonstrated in group II (P < 0.001). The two subgroups of group I showed statistically nonsignificant differences in the hospital stay length and the days to return to normal activity, despite higher values in the Seal group [Table 2].

The postoperative Ht (%) was significantly different among the three groups (P = 0.017), with the lowest mean value noted in group II. No significant difference was noted between group IA and group IB [Table 2].

The lowest mean value of postoperative Hb was seen in group II also. However, this difference did not reach the level of significance (P = 0.13) [Table 2].

No significant differences were noted concerning the frequency of drain insertion, or the frequency of blood transfusion (P > 0.05) [Table 2].

The patients' pain scores in 3 days postoperatively as graded by VAS are demonstrated. The worst pain scores in the 3 days were demonstrated in group II, with statistically highly significant difference (P < 0.001). Subsequently, the injection analgesics needs were higher in group II, with statistically highly significant difference (P < 0.001). The subgroups IA and IB showed statistically significant differences in pain scores of day 3 only, with less mean scores in the Ligasure group [Table 3].
Table 3: Postoperative pain score and injected analgesics need

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  Discussion Top


EBVS has become established as a vessel sealing procedure in both open and laparoscopic surgery. Several advantages for the EBVS during vaginal hysterectomy were documented. These were less hemorrhage, less postoperative pain, and reduced length of hospital stay. Only few studies have assessed the EBVS in patients undergoing abdominal hysterectomy for benign conditions[4]. In this study, the demographic data of the patients were comparable with no significant differences among groups.

Regarding the primary outcome in this study, which was the difference between the two major groups, conventional suturing and EBVS, there was statistically highly significant difference in the operative time, as it was significantly reduced in the EBVS group.

These results are in agreement with the recent Egyptian study of Mohamed et al.[5] who conducted a study to compare LigaSure use versus conventional suturing in total abdominal hysterectomy, they included seventy patients who were scheduled for elective hysterectomy and found that EBVS use was associated with reduced surgery time. The previous work of Suprasongsin and Boonyakitanon[4], who presented controlled trial comparing the effects of conventional suturing and EBVS in women undergoing abdominal hysterectomy for benign conditions, and included sixty patients undergoing abdominal hysterectomy for benign conditions, reported that the mean surgery time in conventional suturing group was 12 min higher than EBVS group. In another controlled trial that was driven by Aydin et al.[6], it was observed that the EBVS device significantly reduced the surgery time.

On the other side, Lakeman et al.[7] found that the surgery time was comparable in EBVS and conventional suturing groups, those were having abdominal hysterectomy for benign disorders. Likewise, in the controlled trial of Darwade et al.[8], which was performed in India, the authors reported no superiority of EVBS in regard to the surgery time in patients undergoing abdominal hysterectomy for benign disorders.

The present study revealed that the EBVS had statistically highly significant decrease in the amount of blood loss. The postoperative Ht (%) was significantly differing also between the two groups, with lower mean value noted in conventional hysterectomy group. Conventional hysterectomy group also showed lower mean value of postoperative Hb. However, this difference did not reach the level of significance. This difference in hemostatic parameters may be explained by the considerable time needed by suturing technique that increased blood loss in hysterectomy[9].

The authors reported less blood loss in the EBVS group compared with the conventional hysterectomy group. The same was revealed by Mohamed et al.[5], Aydin et al.[6], Darwade et al.[8], Levy and Emery[10], and Ding et al.[11].

Aydin et al.[6], as in the current study, showed that the difference in the postoperative Hb between the two groups was insignificant. The results of Lakeman et al.[7] study, however, did not find any significant reduction of blood loss. This was similar to what was found by Hefni et al.[12] and Hagen et al.[13]. This might be explained by that the EBVS was just introduced and the experiences of users were still limited.

In this study, the EBVS group showed significantly shorter hospital stay, this is consistent with the study of Levy and Emery[10] who found that EBVS resulted in less hospital stay. The results are, however, inconsistent with other studies that found comparable hospital stay length in both groups[2],[5],[6],[7],[8],[14].

In this study, the patients in EBVS group needed less days for returning to the usual activities, with high significant difference. It has been supposed that the rapid resuming of usual daily activities in the EBVS group is actually consequent to the decreased postoperative pain that offers more comfortable recovery of patients[15]. Suprasongsin and Boonyakitanon[4] study documented that patients who underwent EBVS sealing procedure require less recovery period than those in the conventional suture group.

The patients' pain scores in three days postoperatively as graded by VAS were analyzed in this study. The EBVS group demonstrated better pain scores in the 3 days, with statistically high significant differences. Subsequently, the injection analgesics needs were less, with also statistically highly significant difference.

This is the same as what was found by Mohamed et al.[5] as they reported a significant reduction in postoperative pain in the evening after surgery, day 1, day 2 among the vessel-sealing group, and these data were manifested by reduction of postoperative analgesics requirements and better outcome in the VAS scoring system. Suprasongsin and Boonyakitanon[4] also mentioned that one important parameter that indicated an indirect benefit of EBVS is less pain. These results also agree with the data mentioned in Nouri et al.[14], Cronje and de Coning[16], and Douay et al.[17] studies, which stated that pain was significantly reduced in the EBVS group. Reduced pain could be attributed to the effect of EBVS device, which does not press on tissues and coagulate nerves where they are cut. Moreover, additional clarification is that during vessel sealing, the tissue traction and the autonomic innervation surrounding the uterus are avoided. Therefore, the EBVS clamp does not yield any force on the tissues surrounding the uterus.[5] Suprasongsin and Boonyakitanon[4] stated that the possible mechanism is less healing reaction in the EVBS group due to less injury to the surrounding tissue during operating process.

In respect to the secondary outcome of this study, the present study further assessed the difference between the conventional bipolar-sealing system; Seal and the advanced one; LigaSure. The LigaSure showed less operative time when compared with the Seal system. However, the difference was nonsignificant.

No significant differences were noted between EBVS subgroups concerning the mean blood loss or the postoperative Ht (%), hospital stay, and days for return to normal activity. Less pain scores were shown in the LigaSure group. This is in agreement with the Lee et al.[18] study.

The strength points of the present study are that it is a prospective controlled study, and combining the comparison between conventional suturing and the EBVS system, together with head-to-head comparison of the conventional and advanced bipolar devices regarding the efficacy in abdominal hysterectomy for benign indications.


  Conclusion Top


EBVS is an expensive but an effective alternative to the conventional sutures in the abdominal hysterectomy for benign conditions. It exhibited significant reduction in surgery time, blood loss, hospital stay length, postoperative pain, and days for resuming normal activities, without increasing the rate of occurrence of complications.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Rabiu A, Habib R. Elective abdominal hysterectomy: appraisal of indications and complications at Aminu Kano Teaching Hospital – an 8-year review. Trop J Obstet Gynaecol 2017; 34:224–228.  Back to cited text no. 1
    
2.
Macario A, Dexter F, Sypal J, Cosgriff N, Heniford BT. Operative time and other outcomes of the electrothermal bipolar vessel sealing system (LigaSure) versus other methods for surgical hemostasis: a meta-analysis. Surg Innov 2008; 15:284–291.  Back to cited text no. 2
    
3.
Burkman RT. TeLinde's operative gynecology. JAMA 2012; 307:1088–1089.  Back to cited text no. 3
    
4.
Suprasongsin C, Boonyakitanon M. Comparison of conventional suture versus electrosurgical bipolar vessel sealing in abdominal hysterectomy: a randomized control trial. J Health Sci 2012; 21:3.  Back to cited text no. 4
    
5.
Mohamed MA, Eid SM, Ayad WA, Emam AA. Comparative study of electrosurgical bipolar vessel sealing using ligasure versus conventional suturing for total abdominal hysterectomy. IJMA 2020; 2:698–704.  Back to cited text no. 5
    
6.
Aydin C, Yildiz A, Kasap B, Yetimalar H, Kucuk I, Soylu F. Efficacy of electrosurgical bipolar vessel sealing for abdominal hysterectomy with uterine myomas more than 14 weeks in size: a randomized controlled trial. Gynecol Obstet Invest 2012; 73:326–329.  Back to cited text no. 6
    
7.
Lakeman M, Kruitwagen RF, Vos MC, Roovers JP. Electrosurgical bipolar vessel sealing versus conventional clamping and suturing for total abdominal hysterectomy: a randomized trial. J Minim Invasive Gynecol 2008; 15:547–553.  Back to cited text no. 7
    
8.
Darwade S, Hol K, Trivedi S, Shekhawat G. Randomized trial of suturing versus electrosurgical bipolar vessel sealing in abdominal hysterectomy. Int J Reprod Contracept Obstet Gynecol 2016; 5:1778–1783.  Back to cited text no. 8
    
9.
Kyo S, Mizumoto Y, Takakura M, Hashimoto M, Mori N, Ikoma T, et al. Experience and efficacy of a bipolar vessel sealing system for radical abdominal hysterectomy. Int J Gynecol Cancer 2009; 19:1658–1661.  Back to cited text no. 9
    
10.
Levy B, Emery L. Randomized trial of suture versus electrosurgical bipolar vessel sealing in vaginal hysterectomy. Obstet Gynecol 2003; 102:147–151.  Back to cited text no. 10
    
11.
Ding Z, Wable G, Rane A. Use of LigaSure bipolar diathermy system in vaginal hysterectomy. J Obstet Gynaecol 2005; 25:49–51.  Back to cited text no. 11
    
12.
Hefni MA, Bhaumik J, El-Toukhy T, Kho P, Wong I, Abdel-Razik T, et al. Safety and efficacy of using the LigaSure vessel sealing system for securing the pedicles in vaginal hysterectomy: randomized controlled trial. BJOG 2005; 112:329–333.  Back to cited text no. 12
    
13.
Hagen B, Eriksson N, Sundset M. Randomized controlled trial of LigaSure versus conventional suture ligature for abdominal hysterectomy. Br J Obstet Gynecol 2005; 112:968–970.  Back to cited text no. 13
    
14.
Nouri K, Ott J, Demmel M, Promberger R, Huber JC, Mayerhofer K. Bipolar vessel sealing increases operative safety in laparoscopic-assisted vaginal hysterectomy. Arch Gynecol Obstet 2011; 283:91–95.  Back to cited text no. 14
    
15.
Davidson ER, Kho R. Use of vessel-sealing devices during vaginal hysterectomy. J Minim Invasive Gynecol 2019; 26:362.  Back to cited text no. 15
    
16.
Cronje HS, de Coning EC. Electrosurgical bipolar vessel sealing during vaginal hysterectomy. Int J Gynaecol Obstet 2005; 91:243–245.  Back to cited text no. 16
    
17.
Douay N, Belot F, Bader G, Guyot B, Heitz D, Fauconnier A. Postoperative pain after hysterectomy through vaginal routes using electrosurgical bipolar vessel sealing versus conventional suture ligation. Gynecol Obstet Fertil 2007; 35:632–636.  Back to cited text no. 17
    
18.
Lee CL, Wu KY, Huang CY, Yen CF. Comparison of LigaSure™ tissue fusion system and a conventional bipolar device in hysterectomy via natural orifice transluminal endoscopic surgery (NOTES): a randomized controlled trial. Taiwanese J Obstet Gynecol 2019; 58:128–132.  Back to cited text no. 18
    


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