Outcome of Gynecologic Laparoendoscopic Single-Site Surgery with a Homemade Device and Conventional Laparoscopic Instruments in a Chinese Teaching Hospital.

OBJECTIVE: To demonstrate various benign gynecologic diseases that can be performed by laparoendoscopic single-site surgery (LESS) with conventional laparoscopic instruments.
METHOD: Patients with benign gynecologic diseases that need ovarian cystectomy, fallopian tube resection, or myomectomy were divided into experimental group and control group, and perioperative outcomes of these patients were analyzed.
RESULTS: From November 2017 to May 2018, 65 LESS gynecological surgeries were performed, among which there were 25 ovarian cystectomies, 28 unilateral fallopian tube resections, and 12 myomectomies. All the surgeries were completed smoothly, and only one surgery needed one more additional port. No patients have severe complications. Operative time, intraoperative blood loss, and perioperative complications have no difference between the two groups. The LESS laparoscopy group had less postoperative pain scores and longer bowel recovering time, compared with the conventional laparoscopy group (<0.05).
CONCLUSION: Compared with traditional laparoscopy, LESS surgery with conventional laparoscopic instruments is feasible and safe, but postoperative exhaust time is longer than the control group.

1. Introduction

As one type of the laparoscopic surgery, the laparoendoscopic single-site (LESS) surgery has been developed in an attempt to further reduce the morbidity and scarring associated with surgical intervention [1, 2]. Single-site gynecologic Surgery is widely carried out all over the world during the recent years. More and more gynecological endoscopic surgeries use this single-site technology, especially transumbilical single-port. Many research studies have indicated advantages of it, such as less postoperative pain, quick recovery, and less skin scar. Some results are conflicting [3-10]. The advantages of LESS are still uncertain. In this study, we analyzed perioperative and postoperative data of single-site laparoscopic surgery and multihole laparoscopic surgery to explore the difference in clinical efficacy between the two groups.

2. Methods

This study was a retrospective study performed in GuangZhou women and children's Hospital, from November 2017 to May 2018. The study was approved by the hospital's ethics committee. All the patients signed the informed consent. The patients who have a history of previous abdominal surgery or BMI >30 were excluded. All the operations were performed by the same doctor who had completed more than 20 LESS surgeries before the research. Similar cases in the research period through conventional laparoscopy were involved into the control group.

2-3 cm longitudinal umbilical incision was measured by a sterile ruler and single-port access by sequence incision to the peritoneum through the periumbilical incision. We inserted the inner ring of the wound retractor and fixed a 6½ size surgical glove on the outer ring of the retractor. One 10 mm trocar and two 5 mm trocars were inserted into the glove fingers and fixed by silk thread. The 10 mm rigid 30° Karl Storz laparoscopy was inserted into the abdominal cavity through the 10 mm trocar, and the conventional laparoscopic instruments were inserted through the other two trocars (Figure 1).

Figure 1

Homemade single-port device made of one retractor and one glove.

We reviewed all the medical records including the operation time, blood loss, length of hospital stay, bowel recovering time, and postoperative Visual Analog Scale (VAS) score. The VAS was used to score incisional pain on a 10-point scale ranging from 0 (no pain) to 10 (worst possible pain). All the perioperative outcomes of LESS surgery group were compared with the traditional multiport laparoscopic surgery groups.

3. Statistical Analyses

The parametric variables were expressed as mean ± standard deviation (SD), minimum and maximum, and were compared with a t-test. Categorical variables were compared with a Chi-squared test. We used SPSS 22.0 for statistical analyses. The level of statistical significance was set at p < 0.05.

4. Results

25 ovarian cystectomies, 12 myomectomies, and 28 unilateral fallopian tube resections have been involved in the LESS group.

In our study, there was no significant difference from the general clinical data between the two groups of patients whether performing adnexal surgery, salpingectomy, or myomectomy. The differences of hospital stays and bowel recovering time between the two groups are significant for the ovarian cystectomies, and the LESS group needed longer time for bowel recovering (Table 1).

Table 1

Clinical characteristics and operative data of ovarian cystectomy (N = 50).

Variable	LESS	ConventionalLS	p value
Patient age	32.35 ± 5.32	33.29 ± 4.89	>0.05
BMI	21.43 ± 3.15	21.04 ± 1.70	>0.05
Operating time	114.64 ± 27.75	106.07 ± 33.43	>0.05
Blood loss	28.24 ± 15.78	32.35 ± 51.56	>0.05
Pain score 24 h	1.29 ± 0.54	2.88 ± 0.42	>0.05
Bowel recovering time	1.65 ± 0.54	1.41 ± 0.48	<0.05
Hospital stay in days	3.64 ± 1.26	3.24 ± 0.92	<0.05

For the myomectomies, there is a significant difference of bowel recovering time between the two groups, and the LESS group needs longer time for bowel recovering compared with the conventional laparoscopy group. The difference of 24 h pain between the two groups is significant, and the LESS group has less 24 h VAS compared with the conventional laparoscopy group (Table 2).

Table 2

Clinical Characteristics and Operative Data of myomectomy (N = 24).

Variable	LESS	Conventional LS	p-value
Patient age	38.82 ± 6.52	38.27 ± 4.36	>0.05
BMI	22.20 ± 3.42	23.20 ± 2.00	>0.05
Operating time	116.36 ± 59.12	128.64 ± 68.72	>0.05
Blood loss	79.09 ± 92.46	64.54 ± 85.60	>0.05
Pain score 24 h	1.36 ± 1.03	2.0 ± 0.97	<0.05
Bowel recovering time	1.71 ± 0.51	1.36 ± 0.50	<0.05
Hospital stay in days	4.81 ± 1.79	4.82 ± 1.17	>0.05

For the salpingectomy, there is a significant difference of VAS between the two groups. We did not find differences of other items between the two groups (Table 3).

Table 3

Clinical characteristics and operative data of salpingectomy (N = 56).

Variable	LESS	Conventional LS	p-value
Patient age	31.17 ± 3.13	31.52 ± 4.35	>0.05
BMI	20.85 ± 2.50	21.08 ± 2.18	>0.05
Operating time	61.26 ± 30.68	50.81 ± 14.19	>0.05
Blood loss	20.70 ± 56.27	18.18 ± 37.19	>0.05
Pain score 24 h	1.26 ± 0.71	2.44 ± 0.70	<0.05
Bowel recovering time	1.55 ± 0.50	1.07 ± 0.26	>0.05
Hospital stay in days	3.22 ± 2.43	3.14 ± 1.38	>0.05

5. Discussion

Laparoendoscopic single-site surgery (LESS) is a single-port technique through the umbilicus, in the past 10 years, and it has emerged as a potentially less-invasive alternative to multiport laparoscopy. It has enhanced the cosmetic benefit of minimally invasive surgery. At the beginning, a homemade single port is easier to get, low cost and has a good socioeconomic performance, especially for the countryside hospitals. YH Park was the first person who reported that he use a homemade single port device to perform laparoendoscopic single-site nephrectomy [11]. Several meta-analysis researches have been published on the safety and efficacy of LESS in recent years [9, 12–14]. However, it has been unclear whether LESS offers benefits over multiport LH. Sandberg et al. [15] reported that potential benefits were cosmetic satisfaction and less postoperative pain, but the small differences for these outcomes appear not to be of clinical relevance in their systematic review and meta-analysis report. In our study, most items we observed have no difference between two groups.

In the application of any new technique, the safety of the patients is always the most important. In our study, all the surgeries were successfully performed. After a median follow-up period of 3 months, there is no complaint of the LESS surgery. All the LESS group patients were fully satisfied with the appearance of the incisions.

Operating time is routinely considered as a parameter to estimate the surgical learning curve. In our study, there is no difference for adnexal surgery, salpingectomy, or myomectomy. We considered there are different possible reasons for it. (1) Regarding salpingectomy, it is relatively simple for a doctor who passed the learning curve of LESS. (2) For myomectomy, although the surgeon faced additional challenges such as crossing or collision of instruments, lack of triangulation and inline vision in the LESS group, it will take longer to get the myoma out from abdominal through uterine circumcisor in the conventional laparoscopy group. But when considering patients with peritoneal adhesions or previous abdominal surgery history, LESS surgery is supposed to be more difficult and longer OR time is needed.

We find VAS score was slightly lower in the LESS group at postoperative 24 hours for the salpingectomy, and this difference has statistical significance. Sangnier et al.'s [16] retrospective study involving 87 patients who underwent adnexal surgery indicated that there was no difference in pain scores at 2 or 24 hours after surgery. Jeong Eom's prospective case-control study which included 399 women indicated that the pain score was significantly lower in the LESS group compared with the conventional laparoscopic surgery group only at 2 hours after surgery, but no differences in VAS score at 48 and 72 hours after surgery [17]. They suspected that patient-controlled analgesia narrowed the difference in pain of the two groups. In our study, the result of postoperative pain is similar to Eom's research.

The homemade single-port has some advantages and disadvantages [18, 19]. Advantages are (1) because each trocar is not fixed on the single port, the space between the trocars is more flexible and (2) it is much cheaper than the made-up single port. The disadvantages are (1) the glove is easily broken and (2) it is not very convenient to assemble. According to our experience, after the learning curve, the conventional instruments are up to most of the surgeries.

The present study has several limitations. First, the number of patients was small, and follow-up was over the short term. Second, the differences between the preoperative and postoperative results were minimal and may have resulted from a type II error.

6. Conclusion

LESS surgery is less invasive, suitable and safe for gynecological surgery. The homemade single-port device is cheap and suitable to spread especially in the developing region.