PRECIS: Barbed sutures facilitate the suturing process and reduce the time required to suture the uterine wall defect, blood loss, and the need for postoperative blood transfusion.

Introduction

Myoma is the most common tumor in the uterus⁽¹⁾. Although it is usually asymptomatic, it can also present clinical problems such as abnormal levels of uterine bleeding, pelvic pressure/pain symptoms, or infertility⁽²⁾. Various medical and surgical methods have been used for treating myoma⁽³⁾. However, the most effective and curative treatment today is still surgery⁽⁴⁾.

Myomectomy can be performed abdominally, laparoscopically, or hysteroscopically. A comparison between laparoscopic and laparotomic surgery demonstrated that the former resulted in shorter hospital stays, faster recovery, less postoperative pain, and better cosmetic results⁽⁴⁾.

As with all myomectomy cases, excess bleeding is one of the most important complications of laparoscopic myomectomy^(5,6). Although many prophylactic methods have been used to reduce bleeding, no single method has had a 100% success rate, and research on new methods should be supported^(7,8,9).

In the case of myomectomy, suturing is the quickest and the most effective procedure to stop bleeding. Therefore, the use of a barbed suture in laparoscopic myomectomy was proposed to simplify suturing, which is the most challenging part of the operation⁽¹⁰⁾.

It is thought that a barbed suture will provide rapid and easy suturing due to its small spines, which hold onto the tissue well, do not loosen, and do not require intracorporeal suturing through the loop design at the other end of the suture⁽¹¹⁾. It is foreseen that intraoperative blood loss will be reduced due to this rapid and easy suturing technique^{(12,13,14,15)}.

Although some previous studies have investigated the efficiency of the barbed suture in laparoscopic myomectomy, these studies were primarily retrospective^{(10,11,12,13,14,15)}. The main aim of this study was to compare the frequently used Vicryl suture with the barbed suture in terms of intraoperative bleeding and suture time in laparoscopic myomectomy cases. Our secondary objectives are to compare the sutures in terms of the operation time, postoperative hemoglobin drop, and the need for postoperative blood transfusion. Thus, we objectively demonstrate the superiority of the conventional Vicryl suture, which is cheaper and more accessible, versus the newer and more expensive barbed suture.

Materials and Methods

This prospective, randomized clinical trial was conducted between May 2018 and May 2019 at the Antalya Training and Research Hospital. Approval was obtained from the hospital’s local ethics committee before any study-related procedures were conducted (approval number: 8-16). The participants provided written informed consent before participation.

Study Population, Patient Sampling, and Randomization

Non-pregnant, reproductive age patients with myoma symptoms and indications for laparoscopic myomectomy were included in the study. The diagnosis of the myoma uteri was classified according to the FIGO Leiomyoma Subclassification System⁽¹⁶⁾. Because H/S (Hysteroscopy) myomectomy was planned for type 0, 1, and 2 fibroids, these were excluded from the study. The study excluded types 7 and 8 fibroids because their suturation requirements were minimal. Type 3 fibroids were also excluded from the study due to the strong possibility of entering the endometrial cavity aggravating the suturation. Finally, multiple myomas were excluded from the study.

Patients with a single type 4, 5, or 6 fibroids and a uterine size reaching the maximum umbilicus level (20-W gestation size) were included in the study. Laparotomy was planned for larger uteruses.

Patients were randomized by 1:1 simple randomization using sealed envelopes. One day before the operation, the service nurse opened the envelope to determine the method to be used on the patient. During the procedure, the fibroids were repaired using Vicryl suture in the first group and barbed suture in the second group. Patients’ demographic data (age, gravida, parity, previous abdominal surgery, and chronic diseases), intraoperative findings (operation time, myomectomy time, suture time, number of suture layers, amount of intraoperative bleeding, and fibroid weight), preoperative and postoperative hemoglobin/hematocrit values, postoperative blood transfusion requirements, and hospital stay duration were recorded.

Operation Procedure

All operations were performed by the same surgeon (BM). The first entry into the abdomen was made by direct trocar entry from the umbilicus or Lee Huang point according to the size of the fibroid, and a 10-mm laparoscope was placed in this port. The 30-degree optic was used in all cases to provide a wide viewing angle. Then, 5-mm accessory trocars were placed in the right and left lower quadrant and suprapubic area. Rumi II was used as the uterine manipulator. A Harmonic scalpel (Ethicon Endo-Surgery, Cincinnati, OH, USA) was used to create the incision in the uterine serosa. A Vicryl (Ethicon, Somerville, NJ, USA) 0 USP 40-mm ½ taper needle suture was used for the Vicryl group patients. A V-Loc 180 (Covidien, Mansfield, MA, USA) 0 USP 37-mm ½ taper needle suture was used for the barbed suture group patients. One, two, or three layers were closed continuously depending on the depth of the fibroid inside the myometrium. All fibroids were morcellated with a Rotocut G1 electronic morcellator device (Karl Storz, Tuttlingen, Germany) and then removed from the abdomen.

Hemoglobin was measured the day before the operation and at the eighth postoperative hour. A cut-off value of <7 g/dL was determined for blood transfusion. Transfusion was performed in symptomatic patients with higher values.

Statistical Analysis

Data were recorded and analyzed using IBM SPSS Statistics for Windows (Armonk, NY: IBM Corp.). The Shapiro–Wilk test was used to determine the suitability of the data to the normal distribution curve. Normally, distributed data are shown as means ± standard deviations; non-normally distributed data are shown as medians and ranges. For categorical data, n (number/frequency) and percentages (%) are used. Parametric methods were used for the analysis of normally distributed variables, and non-parametric methods were used for the analysis of non-normally distributed variables. To compare two independent groups, the independent samples t-test, and Mann-Whitney U test were used. Categorical data were compared using the Chi-squared test. The data were analyzed at a 95% confidence level, and  p<0.05 was considered statistically significant.

Results

A total of 108 patients were included in the study; however, only 75 of them completed the study. The study flow diagram is presented in Figure 1. The two study groups were similar with respect to age, body mass index, previous abdominal surgeries, the weight of myoma, diameter of myoma, localization of myoma, and layers of suturation. Patients’ demographic and clinical characteristics are shown in Table 1.

The perioperative findings are presented in Table 2. The suture time was significantly lower in the V-Loc suture group compared with the Vicryl suture group (p=0.007). Similarly, blood loss and postoperative blood transfusion requirements were lower in the V-Loc group (p=0.018, and p=0.048 respectively). However, operative time, postoperative hemoglobin and hematocrit change, and hospital stay duration were similar between the two groups (p>0.05 for all) (Table 2).

No organ or vessel injury was observed during the procedures. In three cases, conversion to laparotomy was required because of the restriction of the mobilization of the uterus, and these patients were excluded from the study.

Discussion

Unlike other randomized studies in the literature, this study was carefully planned to investigate the effectiveness of suturing, focusing only on an intraoperative hemorrhage. Therefore, the exclusion criteria were kept wide, and no medical or surgical methods were used to reduce bleeding. Additionally, all operations were performed by the same surgeon for the objective of the study, as the suturation procedure is directly dependent on the hand skills of the surgeon.

In line with other studies in the literature, the present study results indicate that barbed sutures shorten the suturation time in laparoscopic myomectomy cases, thereby reducing intraoperative bleeding and postoperative blood transfusion needs. The use of barbed sutures in laparoscopic myomectomy was first introduced by Greenberg and Einarsson⁽¹⁰⁾ in 2008. There have since been a few studies have investigating the efficiency of the barbed suture in laparoscopic myomectomy cases. Of these, only three were randomized clinical trials, and the rest were retrospective studies⁽¹⁷⁾.

The randomized studies by Alessandri et al.⁽¹¹⁾ and Ardovino et al.⁽¹⁴⁾ had similar designs. The amount of intraoperative hemorrhage was not quantitatively measured in either study; instead, hemoglobin decline was calculated to determine the amount of bleeding. However, the hemoglobin concentration is affected by many factors and does not objectively reflect the amount of bleeding. In both trials, the surgeries were performed by two different surgeons. Since the rate of suturation of each surgeon may be different, this may have been a confounding factor that impacted the suturation times^(11,14).

In a randomized study by Giampaolino et al.⁽¹⁵⁾, all operations were performed by the same surgeon. Thus, that study was like the current research. However, for all three of these studies, fibroids were not classified by type^(11,14,15). In one study, only the size of the fibroids was recorded⁽¹⁵⁾. However, it is known that difficulty in suturing after myomectomy is related to the area of ​​the myoma in the myometrium, regardless of the size of the myoma.

In our study, the duration of the operations was the same in both groups because the surgeon was experienced in conventional intracorporeal suturation. If barbed suturing was performed by surgeons with less experience in intracorporeal suturing, the differences between the two types of sutures may be more evident.

Conclusion

This study revealed that the barbed suture facilitates suturing, shortens the suturing time and reduces the need for a postoperative blood transfusion by decreasing the amount of intraoperative bleeding during laparoscopic myomectomy. Additional studies involving less experienced surgeons with suturing could demonstrate its advantages more clearly.

Ethics

Ethics Committee Approval: Approval was obtained from the hospital’s local ethics committee before any study-related procedures were conducted (Antalya Training and Research Hospital - approval number: 8/16, date: 19.04.2018).

Informed Consent: The participants provided written informed consent before participation.

Peer-review: Internally peer-reviewed.

Surgical and Medical Practices: B.M., Concept: S.A.T., B.K., Design: S.A.T., B.K., Data Collection or Processing: C.K., G.D.T., S.K., Analysis or Interpretation: S.A.T., C.K., G.D.T., Literature Search: B.K., Writing: S.A.T., B.K.

Conflict of Interest: No conflict of interest was declared by the authors.

Financial Disclosure: The authors declared that this study received no financial support.