Single-port laparoscopically assisted-transumbilical ultraminilaparotomic myomectomy (SPLA-TUM) versus single port laparoscopic myomectomy: a randomized controlled trial

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Abstract

Objective

To evaluate whether single-port laparoscopically assisted-transumbilical ultraminilaparotomic myomectomy (SPLA-TUM) has a shorter operating time than single port laparoscopic myomectomy (SP-LM), without negatively affecting postoperative pain and cosmesis.

Study design

We performed a randomized controlled trial at a University teaching hospital. A total of 92 premenopausal women with symptomatic, superficial intramural or subserosal fibroids were randomized to receive either SPLA-TUM or SP-LM. The primary outcome measured was the operating time. The secondary outcome measures included postoperative pain, as measured by a visual analog scale (VAS) at 2, 6, 12, 24, and 48 h after the operation, and cosmetic outcomes, as measured by the Vancouver scar scale (VSS) and patient satisfaction with the scars, using a VAS at 3 postoperative months.

Results

There were no differences in the patient demographics or in the clinical characteristics of the resected fibroids between the two groups. The operation results showed no differences in the hemoglobin changes, return of bowel activity, hospital stay, and complication rate between the groups. The mean operating time in the SPLA-TUM group was shorter than that in the SP-LM group (87.0 ± 32.7 min compared with 102.3 ± 32.9 min, P = 0.026). The patients in each group demonstrated no differences in their postoperative pain levels, VSS scores, and satisfaction with the scars, but the SPLA-TUM group had a longer umbilical wound compared with the SP-LM group. Two (4.3%) patients in the SPLA-TUM group received SP-LM. One (2.2%) patient in the SP-LM group and two (4.3%) patients in the SPLA-TUM group were converted to two or three port laparoscopic myomectomy.

Conclusions

SPLA-TUM has a shorter operating time than SP-LM due to convenient suturing and knotting; the two procedures have comparable postoperative pain levels and cosmetic outcomes. However, further study is needed to evaluate the long-term outcomes of SPLA-TUM.

Introduction

Since single-port laparoscopic myomectomy (SP-LM) was first introduced [1], [2], various studies of this procedure have been published [3], [4], [5], [6], [7]. However, compared with the extensive research on single port laparoscopic surgeries in other gynecologic fields, studies of SP-LM are sparse. This discrepancy might be because of the distinct characteristics of myomectomy, which has excision and suturing unlike those in other (mainly destructive) surgeries. Furthermore, single-port laparoscopic surgery (SP-LS) is difficult to apply in myomectomy because it is inevitably accompanied by technical difficulties, particularly in laparoscopic suturing and knotting.

To overcome the technical disadvantages of SP-LM, the authors developed a new surgical technique called ‘Single-port Laparoscopically Assisted-transumbilical Ultraminilaparotomic Myomectomy (SPLA-TUM)’ by integrating the advantages of both single-port laparoscopy and minilaparotomy [8]. The authors hypothesized that SPLA-TUM might shorten the operating time while maintaining the feasibility, safety, and advantages of single-port laparoscopy. In this study, we evaluated whether SPLA-TUM has a shorter operating time than SP-LM.

Section snippets

Study design

This prospective, randomized, controlled trial was performed at a university teaching hospital from July 2012 to November 2013. The study protocol was approved by the institutional review board at our hospital.

Participants

All premenopausal women (older than 18 years old) scheduled for SP-LM were enrolled. The indications of SP-LM are women with symptomatic, superficial intramural or subserosal type of fibroid on ultrasonographic examination and with a uterus ≤16 weeks gestational size on pelvic examination

Results

During the study period, 116 women were assessed for eligibility; 92 of these women fulfilled both the inclusion and exclusion criteria and were randomly assigned to SPLA-TUM or SP-LM group (46 women in each group) (Fig. 1).

There were no statistically significant between-group differences in the demographics of the participants or in the clinical characteristics of the resected fibroids (Table 1, Table 2).

In terms of operative results, there were no significant differences in the hemoglobin

Comment

In our previous report on the surgical technique and initial experience of SPLA-TUM, we proposed that SPLA-TUM theoretically has several advantages provided by single-port laparoscopy and ultraminilaparotomy [8]. In aspect of single-port laparoscopy, the advantages are (1) favorable cosmetic outcomes and (2) greater applicability, as well as minimizing surgical injuries to the tubes or uterus by better understanding of the anatomical relationship compared with minilaparotomy. On the other hand,

Conflict of interest statement

This article was not supported by any financial funds and not affiliated with the instrumental company referred to in the text.

Condensation

Compared with single port laparoscopic myomectomy, single-port laparoscopically assisted-transumbilical ultraminilaparotomic myomectomy (SPLA-TUM) can shorten surgical times, with comparable postoperative pain and cosmetic outcomes.

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