Robotic-Assisted Laparoscopic Sacrocolpopexy for Pelvic Organ Prolapse: A Single Center Experience in China.

OBJECTIVE: The aim is to investigate the efficiency and outcome of robotic-assisted sacrocolpopexy (RASC) in a cohort of patients with pelvic organ prolapse (POP) in our Gynecology Department.
METHODS: We performed a retrospective study of female patients who underwent RASC in Chinese PLA General Hospital from January 2013 to December 2020. Their clinical features included age, degree of prolapse, menopause time, body mass index, pregnancy, delivery, operation time, and bleeding volume. All patients were followed up for more than 6 months. POP-Q was recorded to evaluate the position of prolapsed organs. PFDI-20, PFIQ-7, and PGI-I were used to evaluate the life quality after surgery.
RESULTS: Twenty-four patients with POP received RASC in our center. The intraoperative bleeding was 86.9 ± 98.3 ml (20-300 ml). The operation time was 143.5 ± 47.3 min (60-240 minutes). The hospitalization time was 10.4 ± 2.1 days (8-16 days). And the follow-up time was 40.8 ± 22.0 months (6-72 months). In the POP-Q follow-up, postoperative Aa, Ba, Ap, Bp, and C were significantly improved than those before surgery (P < 0.05). The objective and subjective cure rate was 100%. PGI-I score was very good in 9 (9/24), very good in 10 (10/24), and good in 3 (3/24). Postoperative PFDI-20 and PFIQ-7 were 2.78 ± 3.82 and 1.57 ± 3.86, which decreased dramatically after surgery (P < 0.05). Mesh exposure occurred in 4 cases (16.7%) at 2-12 months. The exposed diameters were less than 1 cm in 3 cases (2 A/T3/S1) and 1-2 cm in 1 case (3 B/T3/S1). These mesh exposures healed after conservative observation or mesh excision.
CONCLUSION: RASC for POP has the advantage of less bleeding and hospitalization time. It is a minimally invasive option for pelvic organ prolapse.

1. Introduction

Pelvic organ prolapse (POP) is a common disease which occurs in about 40–60% of parous women [1, 2]. It causes a variety of symptoms and decreased the life quality of old women [3]. Because the aging population in China increased gradually, the rates of POP surgery are predicted to grow [4]. Traditional vaginal surgery for POP has been plagued with high failure rates and complications after mesh-transplantation. Sacrocolpopexy has been the gold standard for the treatment of vaginal vault prolapse for decades [5]. It offers better postoperative results than vaginal surgical techniques [6].

With the application of robotic-assisted surgery in gynecologic surgery from 2005, researchers began to introduce this technology into POP surgery. Robotic technology can provide enhanced visualization and wristed instrumentation, enabling surgeons to perform minimally invasive operations [7]. Robotic-assisted sacrocolpopexy (RASC) has been developed as minimally invasive adaptations of sacrocolpopexy [7]. Chinese PLA General Hospital is the first hospital to use robotic-assisted technology in gynecologic surgery in China. RASC has been performed since June 2013. The primary objective of the present study was to report the surgical and patient-centered outcomes as well as adverse events in RASC surgery.

2. Material and Method

We performed a retrospective analysis of patients undergoing RASC for symptomatic apical POP from January 2013 to December 2020 at Chinese PLA General Hospital. Inclusion criteria for RASC were symptomatic apical and anterior prolapse stage ≥ III, negative cervical cytology, and no abnormal uterine bleeding. The concomitant presence of urinary incontinence was not considered an exclusion criterion. RASC was performed using the Da Vinci Robot (Intuitive, Sunnyvale, CA, USA). The clinical data of the patients were collected, including age, body mass index, menopause, pregnancy and delivery times, previous pelvic floor surgery history, internal medicine complications, operation time, bleeding, postoperative complication, and quality of life.

POP was defined according to the pelvic organ prolapse quantification (POP-Q) system. A POP-Q with nine points (points Aa, Ba, Ap, Bp, C, D, Gh, Pb, and TVL) was used. The patients were followed up for more than 6 months by the chief physician by gynecological physical examination and postoperative prolapse evaluation in outpatient. Scores from the Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Floor Impact Questionnaire (PFIQ-7) surveys were used to evaluate preoperative and postoperative life quality outcomes.

The basic data of patients were collected by Microsoft Excel (Microsoft Corporation, Redmond, WA, USA) and statistically analyzed by using SPSS 26.0 software.

3. Results

Twenty-four patients were involved in our study, with a mean age of 63.3. They were all menopausal. Preoperative demographic characteristics are listed in Table 1.

Table 1

Preoperative demographic characteristics.

	Range (n)	Mean ± sd	95%CI
Age (years)	46–77	63.3 ± 11.7
Pregnancy (times)
<3	7 (29.2%)
≥3	17 (70.8%)
Delivery (times)
<3	18 (75.0%)
≥3	6 (25.0%)
BMI	19–29	24.29 ± 2.87	23.2–25.4
Prior hysterectomy	2
Prior POP surgery	0
Prior stress urinary incontinence surgery	0
POP-Q at baseline
Point Ba ≥ − 1	16
Point C ≥ −1	18
Point Bp ≥ −1	6
Occult stress urinary incontinence	0
Urinary urgency	0
Fecal incontinence	0
Vaginal bulge	24

3.1. Intraoperation Information

The mesh materials used for robot-assisted vaginal vault fixation are all Johnson and Johnson mesh. There were no conversions to laparotomy or intraoperative complications.

3.2. Postoperative Follow-Up

24 patients received robotic-assisted operation, including 15 patients who received laparoscopic-assisted hysterectomy (LAH) and bilateral salpingo-oophorectomy (BSO). Mean operation time was 149 min and bleeding was 62.9 ml. Urinary catheter was placed before operation and was removed at 2–4 days after operation. Mean follow-up time was 58.9 months (as shown in Table 2).

Table 2

Postoperative demographic characteristics.

	Range(n)	Mean ± sd	95% CI
Robotic-assisted operation
RASC	9 (37.5%)
LAH + BSO + RASC	15 (62.5%)
Operation time (min)	60–240	149.0 ± 43.7	114.9–172.1
Bleeding (ml)	20–300	62.9 ± 77.5	27.5–146.3
Hospital stay (d)	8–16	8.5 ± 2.9	9.1–11.7
Postoperative catheter placement (d)	2–4	3.0 ± 0.7	2.8–3.3
Follow-up (month)	6–72	58.9 ± 22.5	27.6–54.1

LAH : laparoscopic-assisted hysterectomy; BSO: bilateral salpingo-oophorectomy.

All the patients were followed up for more than 6 months (40.8 ± 22.0 months (6–72 months)). Anatomic outcomes are listed in Table 3. The standard of postoperative objective cure was POP-Q stage I. In outpatient follow-up, stage I was found in all cases. The objective cure rate was 100%. No prolapse recurrence occurred. PGI-I score was very good in 9 (9/24), very good in 10 (10/24), and good in 3 (3/24). Postoperative PFDI-12 and PFIQ-7 decreased dramatically. The subjective cure rate was 100% (as shown in Table 4).

Table 3

POP-Q characteristics of patients underwent RASC.

	Aa	Ba	Ap	Bp	C	Gh	Pb	TVL
Preoperative	0.90 ± 2.43	1.48 ± 2.54	−1.21 ± 2.08	−0.92 ± 2.39	1.52 ± 2.54	4.73 ± 0.44	2.94 ± 0.37	7.88 ± 0.30
Postoperative	−3.00 ± 0.00	−3.00 ± 0.00	−3.00 ± 0.00	−3.00 ± 0.00	−6.06 ± 0.52	4.39 ± 0.24	3.33 ± 0.24	7.67 ± 0.24
F	130.884	86.197	27.492	40.891	28.866	0.249	1.282	0.551
P	0.000	0.000	0.000	0.000	0.000	0.620	0.263	0.462

Table 4

Postoperative QOL of patients underwent RASC.

	PFDI-20	PFIQ-7	PGI-1
Preoperation	76.93 ± 25.31	65.17 ± 31.86
Postoperation	2.78 ± 3.82	1.57 ± 3.86	1.71 ± 0.69
F	44.076	28.265
P	0.000	0.000

However, mesh exposure occurred in 4 cases (16.7%) at 2–12 month after surgery. The exposure diameter was less than 1 cm in 3 cases (2 A/T3/S1) and 1-2 cm in 1 case (3 B/T3/S1) (IUGA/ICS Prosthesis/Graft Complication Classification System). The adverse symptoms were increased vaginal secretions and bloody vaginal secretions. According to the guidelines proposed by the American Society of Obstetricians and Gynecologists (ACOG) and the Gynecological Urology Association (AUGS) in 2017, estrogen ointment and metronidazole suppository were used locally in 3 cases (2 A/T3/S1), and the exposed mesh was partially excised in 1 case (3 B/T3/S1). All patients healed in 3 months.

4. Discussion

Our prospective review shows that RASC is safe and highly effective in treating advanced apical and anterior prolapse at a midterm follow-up. It has obvious advantages in intraoperative bleeding (86.9 ml in average), operation time (149.0 min), and hospitalization time (8.5 days). Also, the urinary catheter can be removed in 3 days after operation. In our follow-up, a significant improvement in POP-Q score and QOL was found in all patients with an overall objective cure rate of 100%. These results indicated that it is a minimal invasive technique for POP.

In 2005, U.S. Food and Drug Administration (FDA) approved Da Vinci surgical system for gynecological surgery. In 2006, the Chinese PLA General Hospital introduced China's first Da Vinci robot operation system. Elliott reported the first series of robot-assisted laparoscopic sacrocolpopexy for high-grade vaginal vault prolapse [8]. The first robot-assisted gynecological operation in China was completed in our hospital in 2009. In 2013, we began to perform RASC for patients with POP. In our series, mean intraoperative bleeding was 86.9 ml and operation time was 149.0 min. Postoperative PFDI-20, PFIQ-7, and PGI-I were significantly improved than before surgery (P < 0.05). The objective and subjective success rate was 100% at more than 6-month follow-up. In previous research studies, Di Marco et al. reported that the average operation time was 210 minutes, and there was no recurrence after 4 months of follow-up [9]. Salamon et al. reported a series of 120 patients who underwent RASC [10]. The average operation time was 161 minutes, and the bleeding volume was the lowest (<100 ml). The cure rate was 89%. Serati et al. systematically reported that the objective cure rate was 84–100% in patients of all prolapses after RASC with an overall recurrence rate of 6.4% [7]. Culligan reported that 97% of the patients were satisfied, 95% of the patients were cured, and there was no prolapse symptom in the PDFI-20 questionnaire [11]. These data show that the RASC is a reliable and mature technique for POP.

The robot-assisted surgery is a dedicated technique, so the learning curve is also important for surgeons, especially for the beginners. In 2018, Carter-Brooks CM et al. found that the dedicated robotic team decreased operative time significantly by 26 minutes during robotic-assisted sacrocolpopexy with a 17.7% reduction [12]. Geller et al. believed that after 20 surgeries, the total time required for RASC surgery was significantly reduced [13]. Mourik et al. described a reduction in operative time after 12 sacral vaginal surgeries and 12 consecutive surgeries [14]. Germain et al. reported an 18% reduction in surgical time after 10 surgeries in 52 patients treated with the RSC over a seven-year period [15]. Similarly, Akl et al. also reported that the operation time was reduced by 25.4% based on the experience of the first 10 cases [16]. We divided 24 patients into two groups by the admission time (Group 1 : 2013.06–2016.06, n = 12; Group 2 : 2016.06–2020.12, n = 12). The mean bleeding and operation time were 92.5 ml and 164.0 min in Group 1 and 29.2 ml and 133.3 min in Group 2, suggesting a 68.0% and 18.7% reduction. The hospitalization decreased from 9.4 days to 7.7 days. These results confirmed that RASC is a feasible procedure with short learning curve. Yet, when we started adopting RASC in 2013, we had performed more than 1000 robot-assisted gynecological operations. For surgeons without any robot-assisted gynecological operation experience, more than 20 cases may be needed to gain enough experience for RASC.

The cost of robotic surgery is an important issue in choosing individual strategies. It includes the purchase and the maintenance of robot platform [17]. In addition, the robotic surgical instruments and the need for professional and special engineering assistance are key factors to be considered [17]. In 2011 Judd reported that the cost of robotic surgery was $8,508, 47% more than commitment ASC ($5,792) and 15.7% more than laparoscopic surgery ($7,353) [18]. In China, the average cost of robotic surgery is $8,400, about 8 times of ASC ($1,000) and about 7 times of laparoscopic surgery ($1,200). Meanwhile the robot-assisted surgery has not been covered by social insurance. The high cost hindered the wide application in China. Therefore, the cost-efficiency analysis is needed to confirm which patients benefit more from robotic surgery.

Our study has some limitations. First, it was a single-center prospective study that did not allow comparing the possible efficacy of RASC with ASC or LASC. Furthermore, the sample size is small due to the high costs. Lastly, we lack the assessment of storage and voiding urinary symptoms before and after surgery.

5. Conclusions

The introduction of robotic technology has significantly improved the efficacy and safety of ASC by converting open surgical procedures to a minimally invasive approach. We think RASC can be recommended to patients with old age or with financial support. Due to the complex manipulation, the operators should have enough practice of laparoscopic surgery. Long-term follow-up is also necessary to help inform surgeons to build a shared decision-making model. The cost-efficiency evaluation is also needed due to the expensive cost of the surgery.