Edited by: Roberto Berretta, University Hospital of Parma, Italy
Reviewed by: Diana Butera, University Hospital of Parma, Italy; Yu Tian, ShengJing Hospital of China Medical University, China
This article was submitted to Obstetrics and Gynecology, a section of the journal Frontiers in Medicine
This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
The aim of this study is to evaluate the initial feasibility, safety, and outcomes of hysterectomy performed by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) at three institutions in Italy.
All women who underwent vNOTES hysterectomy ± salpingo-oophorectomy for benign indications at three tertiary referral medical centers between July 2019 and April 2021 were included in a retrospective analysis. All vNOTESs were performed with the use of Alexis® and Vpath Gel paths® (Applied Medical). Perioperative data were extracted from patient records. Patient satisfaction and dyspareunia were prospectively inquired about at 60 days and 6 months.
Forty-six patients underwent vNOTES in the study period. Indications for surgery included myomas ± metrorrhagia (52.2%), H-Sil/
Our initial experience suggests that introducing vNOTES as an alternative to conventional surgery is feasible and may offer some advantages in selected women.
Laparoscopic procedures have been used in minimally invasive gynecological surgery since the late 1980s. Nowadays, laparoscopic surgery has become the gold-standard approach for most benign and malignant gynecological diseases (
A very attractive feature in gynecological surgery is the possibility to use the vagina to perform natural orifice transluminal endoscopic surgery (NOTES) to avoid entering through the abdomen to gain access to pelvic structures. Surgical procedures through natural orifices (NOTES) such as the mouth, vagina, urethra, and rectum were first described by Kalloo et al. (
Compared to other natural orifices, the transvaginal route for NOTE appears to be preferable, permitting a safe entry and simple closure. The vaginal route has quickly surpassed other transluminal access routes and is currently adopted in various surgical procedures, such as cholecystectomy, appendectomy, sigmoidectomy, nephrectomy, splenectomy, and more recently liver resection and sleeve gastrectomy in bariatric surgery (
Transvaginal NOTES (vNOTES) applied to gynecological conditions is a combination of conventional vaginal surgery and laparoscopic single-port surgery. In the last decade, the use of the vNOTES approach to perform gynecological surgery has been increasingly reported (
In this article, we would like to report our experience with the first introduction of vNOTES in three gynecological centers in Italy, with a focus on feasibility, perioperative outcomes, safety, and patient satisfaction with this technique.
We conducted a multicentric retrospective analysis of the first 46 cases of vNOTES procedures performed at three different institutions: Grande Ospedale Metroplitano Niguarda of Milan, Ospedale Santa Chiara of Pisa, and Ospedale Cannizzaro of Catania. vNOTES were performed for benign gynecological indications between July 2019 and May 2021. All surgeries were performed by five surgeons at the three centers (MM, MI, TS, PM, and PS). vNOTES surgery was not offered to women with suspected pelvic adhesions and/or endometriosis upon pelvic examination, the previous history of pelvic inflammatory disease, virginity, and contraindication to general anesthesia, pneumoperitoneum, or Trendelenburg position. Perioperative data were collected retrospectively from hospital electronic databases and patient files. The following data were collected: age, body mass index (BMI, kg/m2), number of vaginal deliveries and C-sections, previous pelvic and abdominal surgery, indication for operation, type of surgery, total operation time (defined as the time between the incision of the vagina and the closure of the vaginal cuff), intraoperative and post-operative complications, estimated blood loss, serum hemoglobin (Hb) drop (24-h difference between preoperative and post-operative hemoglobin), post-operative pain using the visual analog scale (VAS) score at 6 and 24 h, and length of post-operative hospital stay. All post-operative complications were recorded: any surgical procedure failure, pelvic visceral injury, blood transfusion, vaginal vault bleeding or infection, urinary tract infection, or post-operative fever. Patients were advised to avoid vaginal intercourse for at least 6 weeks after surgery and were scheduled for a post-operative follow-up at 60 days and 6 months. Patient satisfaction and dyspareunia were inquired prospectively at 60 days and 6 months.
Each surgeon started to perform vaginally assisted NOTES hysterectomy with or without salpingectomy/salpingo-oophorectomy. Hysterectomy procedures through vNOTES have been standardized by Baekelandt et al. (
Surgery was performed with the patient in a lithotomy position associated with a slight Trendelemburg. An 18F bladder catheter was inserted to empty the bladder. The perineum and vagina were disinfected using a 10% povidone-iodine solution. General anesthesia or combined general plus spinal anesthesia was used. Preemptive analgesia with paracervical blocks was performed in all women: a saline solution with 0.9% adrenaline and ropivacaine was injected into the vaginal mucosa and uterosacral ligaments. vNOTES hysterectomy involves three surgical steps:
A standard circular incision around the uterine cervix and dissection of the vaginal mucosa were performed. The posterior vaginal fornix was visualized and dissected, and the pouch of Douglas was opened. The uterosacral ligaments were identified, clamped, incised, and sutured. Then, the vescicouterine space was dissected to expose the vescicouterine pouch and the peritoneum was opened. A vaginal port (Gelpoint®, Applied Medical, Rancho Santa Margarita, CA, USA) with Alexis®, (Applied Medical) was installed, and CO2 was insufflated to create a low-pressure pneumoperitoneum (8–10 mm Hg).
Three 10-mm trocars were used in all cases. A standard rigid 0- or 30-degree camera, bipolar forceps, and a sealing device were used. After achieving a sufficient pneumoperitoneum, the broad ligaments and transverse cervical fascia were exposed bilaterally and dissected with the vessel sealer device. The ligaments were sealed and cut near the cervix and uterus to prevent ureteral injury. The uterine and ovarian vessels were sealed and cut stepwise with the sealing device when salpingo-oophorectomy was performed. In the case of bilateral salpingectomy, the utero-ovarian ligaments and the mesosalpinges were sealed. After ensuring hemostasis, the pneumoperitoneum was deflated and the port device was removed to extract the uterus through the vagina, under the protection of the vaginal retractor. We performed cold knife morcellation when the size of the uterus hinders transvaginal specimen extraction.
The vaginal cuff was closed using two coated vicryl sutures (90 cm, polyglactin 910; Ethicon Endo-Surgery, Norderstedt, Germany).
Pre- and intraoperative care were guided as per the ERAS protocol for gynecological procedures, which was implemented at the three centers before this study. With regards to post-operative analgesia, we used paracetamol 1 g i.v. q.i.d. on day 1, with Ketorolac 30 mg i.v. as a rescue. In the three centers involved, different antibiotic prophylaxis schemes had been used, to follow the different hospitals’ protocols. We gave all patients in Milan an antibiotic prophylaxis cefazolin 2 g i.v. and Metronidazole 500 mg 30 min before surgery, plus cefazolin 2 g i.v. and Metronidazole 500 mg as a single dose 8 h after surgery. Cefazolin 2 g iv 30 min before surgery was given in Pisa, while amoxicilline + clavulanic acid 2 g i.v. 30 min before surgery were given in Catania.
GraphPad Prism 7 (GraphPad Software Inc., San Diego, California, USA) program was used for data analysis. The parameters assessed in women have been included in the tables. Category variables have been represented as frequencies and percentages, while continuous variables were represented as averages and standard deviations (SDs).
We compared data observed in our experience to other previous published retrospective data: ordinary or repeated measures (RM) one-way ANOVA, followed by paired sample Tukey’s multiple comparisons test was performed when comparing operative time, Hb drop, VAS, and length of stay, meanwhile Chi-square test was performed when comparing post-operative complication rate and conversion rate.
For all comparisons, the values of
Forty-six patients underwent vNOTES surgery in the study period. In all cases, a vNOTES hysterectomy was performed. The patient’s characteristics and indications for surgery are summarized in
Population features analysis and description (
Population ( |
|
Age (mean ± SD) | 51 ± 7.2 |
BMI kg/m2 (mean ± SD) | 24.4 ± 3.5 |
Hb level (g/dl) (mean ± SD) | 12.6 ± 1.6 |
Parity (mean ± SD) | 1.3 ± 1.0 |
C-section (mean ± SD) | 0.1 ± 0.4 |
Previous abdominal surgery (mean ± SD) | 0.8 ± 0.7 |
Myomas ± metrorrhagia | 24 (52.2%) |
H-Sil/ |
5 (10.7%) |
Adenomyosis ± metrorrhagia | 4 (8.7%) |
BRCA 1/2 mutation | 3 (6.5%) |
Endometrial hyperplasia | 3 (6.5%) |
Ovarian cyst + history of breast cancer | 3 (6.5%) |
Metrorrhagia | 3 (6.5%) |
Hydatiform mole | 1 (2.2%) |
SD, standard deviation.
Perioperative and post-operative outcome of vNOTES in our case series, and comparison with previous studies by Beakelant et al. (
Italian group |
Baecklendant et al. ( |
Su et al. ( |
Lee et al. ( |
Wang et al. ( |
|
Operative time (mean ± SD) | 91.1 (32.6) | 97 (23.8) |
122.7 (17.6) |
88.2 (4.1) |
86.3 (23.7) |
Uterine weight (mean ± SD) | 250.39 (209.1) | 51 (358) |
538.8 (102.9) |
450.0 (24.1) |
352 (159) |
Hb drop 24 h (mean ± SD) | 1.2 (0.8) | 1.5 (0.6) |
1.9 (1.8) |
1.2 (0.1) |
– |
VAS score 24 h (mean ± SD) | 3.3 (1.8) | 1.7 (0.5) |
– | – | – |
Leigh of stay (mean ± SD) | 2.0 (1.4) | 3 (0) |
2.8 (0.2) |
2.8 (0.1) |
2.2 (0.5) |
Post-operative complication ( |
2 (4.3%) | 2 (20%) |
0 |
5 (3.6%) |
0 |
Conversion rate ( |
2 (4.3%) | 0 |
0 |
7 (5.1%) |
1 (5%) |
The data were analyzed statistically by RM-one-way-ANOVA, followed by Tukey’s multiple comparisons and Chi-square test (
All women had very low post-operative pain scores, with a mean post-operative VAS pain score of 3.3 at 24 h. In six (13%) patients, the VAS score was not recorded.
The mean post-operative length of stay was 2 days. Of the 46 patients, 13 (28.2%) were discharged the first day after surgery; meanwhile, 17 (36.9%) were discharged 2 days after surgery. Of these patients, 12 (26.1%) declared to be able to go home the same day. Subsequently, five patients (10.9%) were treated in day surgery. Ten patients (21.7%) were hospitalized for 3–5 days.
Overall, we reported two post-operative complications (4.3%). In one case, the patient developed left ureteral kinking and was readmitted 3 days after surgery for left renal colic. At the same day, she went to a second surgery for removing vaginal vault sutures, left ureteral stent positioning, and colporrhaphy. In the second case, the complication was not related to the surgical procedure. The patient developed post-operative pneumonia, and she was discharged in good clinical condition after 7 days of parental antibiotic therapy.
The pathological examinations confirmed benign conditions in all specimens. At the 60-day follow-up visits, we did not notice any sign of vaginal infection or other problems related to vaginal scar healing. At 6-month follow-up in all patients, we observe the complete healing of the vaginal scar, and no patient reported pelvic pain or dyspareunia.
To the best of our knowledge, this is the first report about the introduction of vNOTES from gynecological centers based in Italy. In the last few years, surgeons have been trying to find the right place for vNOTES in gynecological surgery, with several experiences with this technique being increasingly reported from all over the world (
A potential issue about vNOTES regard the prolongation of operative time. Although, a previous review reported a statistically significant reduction of operative time for vNOTES hysterectomy compared to TLH, laparoscopic-assisted vaginal hysterectomy (LAVH), and single-port laparoscopic-assisted vaginal hysterectomy (
From our initial experience, we observe short mean operative (
Another important feature of vNOTES is that it provides safe entry, easy access, and direct vision of the peritoneal cavity (
However, the first vaginal step of vNOTES surgery, as in conventional vaginal hysterectomy, has been described as the most challenging gone, secondary to the risk of bladder or rectal lesion (
From a technical point of view, in our initial experience, one case of conversion to transabdominal laparoscopy was secondary to the failed attempt to perform colpotomy for a severe pouch of Douglas obliteration caused by unknown endometriosis. Also, Lee et al. (
This confirms that the feasibility of vNOTES is limited in case of severe pelvic adhesions, or in those cases in which entrance to the Douglas pouch is not possible, such as in the presence of rectovaginal endometriosis and scars (
In our experience, the overall conversion rate to laparoscopy was 4.3% and it results in line with the conversion rate to laparotomy describe in the literature for TLH (
Some concerns have been raised about the risk of post-operative wound infection when using a non-sterile entry (
Moreover, avoiding abdominal port insertion may reduce post-operative pain, and other insertion site complications such as post-operative hernia, hematoma, subcutaneous emphysema, and vascular injuries. All these advantages should contribute to reducing the post-operative hospital stay (
The potential impairment of sexual life due to the adoption of the transvaginal route had raised major concerns both in patients and surgeons. In a previous study on the female perception of transvaginal cholecystectomy, 68% and 43% of patients had worries regarding dyspareunia and decreased sensibility during intercourse, respectively (
In vNOTES hysterectomy, the vaginal cuff is incised and closed as in vaginal hysterectomy and TLH, and we did not expect any difference in the incidence of dyspareunia. Anyway, our patients did not report chronic pelvic pain, dyspareunia, or impaired sexual satisfaction at 6-months follow-up. Our data are in line with the one provided by Lee et al. (
In conclusion, vNOTES has proven to be a feasible and safe approach, and we believe that it could help to overcome some limitations of both conventional laparoscopic and vaginal surgery in selected women. We acknowledge that our study has some limitations as the population number and a non-comparative design. Moreover, we must acknowledge that all our centers are referral centers for gynecological surgery, and all the procedures were performed by experienced surgeons, proficient in both vaginal and laparoscopic surgeries. In future studies, we think it would be interesting to assess vNOTES learning curves for surgeons with different levels of experience.
However, we think that our initial experience could help clarify some issues with the adoption of vNOTES for the first time.
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
This study was carried out in agreement with the recommendations of the Good Clinical Practice (ICH/GCP), Ministerial Decree of 1997. All subjects gave written informed consent in accordance with the Declaration of Helsinki (clinical trial number 14354). The studies involving human participants were reviewed and approved by the Università degli Studi di Enna “Kore”. The patients/participants provided their written informed consent to participate in this study.
TS, MLI, PS, and MM conceived and coordinated the project. TS, PS, MLI, MM, PM, BP, TB, and MC performed the surgical procedures. MLI, FM, MF, and GD collected the data and responsible for the data curation. FM and MLI prepared the first draft of the manuscript and responsible for the analysis and visualization of results. MLI, FM, TS, PS, and MM were involved in the interpretation of the data. TS revised it critically. All authors have given their approval for this version to be published.
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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