To test the effects of the implementation of 3D laparoscopic technology for the execution of nerve-sparing radical hysterectomy.
Thirty patients undergoing nerve-sparing radical hysterectomy via 3D laparoscopic (3D-LNSRH, n = 10) or open surgery (NSRH, n = 20) were studied prospectively.
No significant differences were observed in baseline patient characteristics. Operative times were similar between groups. We compared the first 10 patients undergoing 3D-LNSRH with the last 20 patients undergoing NSRH. Baseline characteristics were similar between groups (p>0.2). Patients undergoing 3D-LNSRH had longer operative time (264.4 ± 21.5 vs 217.2 ± 41.0 minutes; p = 0.005), lower blood loss (53.4 ± 26.1 vs 177.7 ± 96.0 mL; p<0.001), and shorter length of hospital stay (4.3 ± 1.2 vs 5.4 ± 0.7 days; p = 0.03) in comparison to patients undergoing open abdominal procedures. No intraoperative complication occurred. One (10%) patient had conversion to open surgery due to technical difficulties and the inability to insert the uterine manipulator. A trend towards higher complication (grade 2 or worse) rate was observed for patients undergoing NSRH in comparison to 3D-LNSRH (p = 0.06). Considering only severe complications (grade 3 or worse), no difference was observed (0/10 vs 2/20; p = 0.54).
3D-laparoscopic nerve-sparing radical hysterectomy is a safe and effective procedure. The implementation of 3D laparoscopic technology allows the execution of challenging operations via minimally invasive surgery, thus reducing open abdominal procedure rates. Further large prospective studies are warranted.
Tumori 2016; 102(4): 393 - 397
Article Type: ORIGINAL RESEARCH ARTICLE
AuthorsFrancesco Raspagliesi, Giorgio Bogani, Fabio Martinelli, Mauro Signorelli, Valentina Chiappa, Cono Scaffa, Ilaria Sabatucci, Marco Adorni, Domenica Lorusso, Antonino Ditto
- • Accepted on 11/05/2016
- • Available online on 27/06/2016
- • Published in print on 03/08/2016
This article is available as full text PDF.
During recent decades, laparoscopy has emerged as the gold standard for the treatment of several gynecologic conditions, in the setting of both benign and malignant diseases (1-2-3). Although several investigations suggested that laparoscopy allows the execution of complex procedures (including the execution of retroperitoneal lymph node dissections and radical hysterectomy), surgical difficulties related to challenging operations limit the widespread diffusion of laparoscopy. Hence, in the last decade, robotic-assisted surgery has been developed in order to overcome limitations of laparoscopic surgery. The robotic platform is related to several advantages, including improved dexterity of the surgeon (with the 7 degrees of freedom of the instruments), physiologic tremor filtering, and 3D visualization. In particular, this latter point represents one of most important aspects for surgeons. Improved visualization results in improved surgery-related outcomes. However, accumulating data suggested that robotic-assisted surgery is related to longer operative time, greater surgical trauma, and higher costs in comparison to conventional laparoscopic surgery (4, 5). Therefore, attempts have been made to merge advantages of robotic-assisted with conventional laparoscopy. The introduction of 3D visualization in the setting of laparoscopy is aimed to improve laparoscopic skills without other disadvantages of the robotic platform (e.g., high acquisition and maintenance costs).
Recently, growing data in different surgical specialties underlined that 3D laparoscopy overcomes outcomes of standard laparoscopy (6-7-8). However, in the setting of gynecologic surgery, few data regarding the use of 3D laparoscopy are available (9). Therefore, we designed the present study in order to show possible benefit and/or limitation related to the implementation of 3D laparoscopy for the management of cervical cancer. We aimed to evaluate how the implementation of 3D laparoscopy surgery has modified our surgical practice. In particular, we sought to describe our experience, reporting perioperative outcomes of consecutive patients undergoing nerve-sparing radical hysterectomy (type C1), thus allowing analysis of the impact of the introduction of 3D laparoscopy into a clinical setting.
This is a prospective study involving a series of consecutive cervical cancer patients undergoing surgery between January 2015 and November 2015. Institutional review board approval was obtained. Preoperatively, all the patients give written informed consent for data collection for research purposes.
Inclusion criteria were as follows: (1) age ≥18 years; (2) diagnosis of locally advanced cervical cancer submitted to neoadjuvant chemotherapy; (3) execution of type C1 (nerve-sparing) radical hysterectomy; (4) at least 30 days of follow-up. Exclusion criteria were (1) consent withdrawal; (2) synchronous malignancies (<5 years). Staging system and architectural grade were reported in accordance with the International Federation of Obstetrics and Gynecologists (FIGO) statements. The WHO taxonomy was used in order to classify histologic subtypes (10).
Patients with locally advanced cervical cancer were informed that neoadjuvant platinum-based chemotherapy followed by surgery represents an experimental option and the standard treatment for locally advanced cervical cancer consists of radiation plus platinum-based chemotherapy (11, 12). Preoperative workup included physical and gynecologic examinations, chest and abdominal computed tomography, and pelvic nuclear magnetic resonance imaging.
Neoadjuvant chemotherapy consisted of 3 cycles of platinum-based chemotherapy. Clinical responses were defined according to the Response Evaluation Criteria in Solid Tumors guidelines (13). Clinical response was defined as complete (disappearance of tumor), partial (at least 30% tumor diameter reduction), no change (<30% in tumor diameter modification), or progression of disease (13). Pathologic responses were classified into optimal response (no residual disease or residual disease: <3 mm) and suboptimal response (residual disease: >3 mm) (11).
Historically, in our department, type C1 radical hysterectomies were performed via open surgery; from August 2015, after the acquisition of 3D laparoscopic technology, all type C1 radical hysterectomies were performed laparoscopically (3D-LNSRH). In fact, in August 2015, we started a systematic implementation of 3D-LNSRH and no open abdominal procedures were performed. A detailed description of surgical technique and treatment algorithm is presented elsewhere (14-15-16). A 3D laparoscopic column (Karl Storz Endoskope, Tuttlingen, Germany) was used for all procedures. Over the study period, no significant differences in the facilities available for patient care were observed. Other aspects of patient management unrelated to surgery remained consistent during the study period. Patients were catheterized with indwelling Foley catheter for 3 days. Moderate or severe de novo urinary incontinence and urinary retention (requiring re-catheterization) were defined as voiding dysfunctions. Operative times were recorded from the first skin incision to the last skin suture. Blood loss was estimated from the contents of suction devices. Hospital stay was counted from the first postoperative day. Surgery-related complications were classified as intraoperative or postoperative complications. Postoperative complications were graded per the Accordion severity system (16). For the purpose of this study, we focused on moderate (grade 2) and severe (grade 3 or worse) complications. Only complications ≤30 days after surgery were analyzed.
Pelvic dysfunctions were classified as changes in voiding, anorectal function, or sexual function that were not recovered at 30 days of follow-up. For the purpose of this study, pelvic dysfunctions recovering/resolving before 30 days were not recorded.
After the execution of neoadjuvant chemotherapy and radical hysterectomy, adjuvant treatments were on the basis of pathologic results (17). Follow-up evaluations were scheduled as previously described (14-15-16).
Basic descriptive statistics as well as univariate and multivariate models were used. Fisher exact test or chi-square were used, appropriately. Odds ratio (OR), hazard ratio (HR), and 95% confidence intervals (CI) were calculated. Normality testing (D’Agostino and Pearson test) was performed to determine whether data were sampled from a Gaussian distribution. The t test and Mann-Whitney U test were used to compare variables with and without Gaussian distribution, respectively. All p values were 2-sided. p Values <0.05 were considered statistically significant. Statistical analyses were performed using GraphPad Prism version 6.0 for Macintosh (GraphPad Software, San Diego, CA, USA) and IBM Microsoft SPSS (Chicago, IL, USA) version 20.0 for Macintosh.
Over the study period, 38 patients with cervical cancer had locally advanced disease. All patients had platinum-based neoadjuvant chemotherapy. Three patients had no surgery due to absence of response or disease progression occurring under neoadjuvant chemotherapy, while 35 patients had type C1 radical hysterectomy (with or without ovarian preservation) plus systematic pelvic lymphadenectomy. Overall, 12 and 23 patients had 3D-LNSRH and NSRH, respectively. We compared the first 10 patients undergoing 3D-LNSRH with the last 20 patients undergoing NSRH.
Baseline and disease characteristics of patients undergoing neoadjuvant chemotherapy plus nerve-sparing radical hysterectomy via 3D laparoscopic (3D-LNSRH) and open surgery (NSRH)
|3D-LNSRH (n = 10)||NSRH (n = 20)||p Value|
|a Chi-square test.|
|BMI = body mass index; CR = complete response; FIGO = international federation of obstetricians and gynecologists; PR = partial response (PR1 with major histologic changes).|
|Age, y, mean ± SD||41.8 ± 7.5||43.3 ± 12.0||0.41|
|BMI, kg/m2, mean ± SD||25.3 ± 3.6||25.9 ± 4.7||0.86|
|Charlson Comorbidity Index ≥1, n (%)||1 (10)||2 (10)||1.00|
|Previous abdominal surgery, n (%)||4 (40)||7 (35)||1.00|
|Histotype, n (%)|
|Squamous cell||8 (80)||15 (75)||0.68|
|Other||2 (20)||6 (25)|
|FIGO grade at preoperative cervical sampling, n (%)|
|Grade 1 and 2||5 (40)||9 (45)||0.80a|
|Grade 3||4 (50)||10 (50)|
|Unknown||1 (10)||1 (5)|
|Stage of disease, n (%)|
|IB2||5 (50)||10 (50)||0.08a|
|IIB-III||3 (30)||10 (50)|
|Clinical response, n (%)|
|Partial response||80 (80)||14 (70)||0.68|
|Complete response||2 (20)||6 (30)|
|Pathologic response, n (%)||1.00|
|CR + PR1||5 (50)||9 (45)|
|30-day of follow-up||10 (100)||20 (100)||1.00|
Operative results of patients undergoing neoadjuvant chemotherapy plus nerve-sparing radical hysterectomy via 3D laparoscopic (3D-LNSRH) and open surgery (NSRH)
|3D-LNSRH (n = 10)||NSRH (n = 20)||p Value|
|No. of nodes yielded, mean ± SD||33.2 ± 11.4||39.1 ± 11.8||0.14|
|Positive nodes, n (%)||1 (10)||2 (10)||1.00|
|Conversion to open surgery, n (%)||1 (10)||—||—|
|Operative time, min, mean ± SD||264.4 ± 21.5||223.0 ± 40.0||0.001|
|Estimated blood loss, mL, mean ± SD||53.4 ± 26.1||177.7 ± 96.0||<0.001|
|Hemoglobin drop, mg/dL, n (%)||1.98 (0.79)||2.73 (1.0)||0.05|
|Blood transfusions, n (%)||0||5 (25)||0.14|
|Hospital stay, d, mean ± SD||4.3 ± 1.2||5.4 ± 0.7||0.03|
|Intraoperative complications, n||0||0||1.00|
|Postoperative complications, grade 2 or worse, n (%)||0||7 (35)||0.06|
|Postoperative complications, grade 3 or worse, n (%)||0||2 (10)||0.54|
|Adjuvant treatment, n (%)||3 (30)||6 (30)||1.00|
No intraoperative complication occurred. One (10%) patient had conversion to open surgery due to technical issues and the inability to insert the uterine manipulator. Patients undergoing NSRH experienced a slightly higher complication rate in comparison to patients undergoing 3D-LNSRH; 7 (35%) patients undergoing NSRH experienced grade 2 or worse postoperative complications (p = 0.06). They included anemia requiring blood transfusions (n = 5), ureteral stenosis requiring stenting (n = 1), and infectious complications (n = 2), requiring percutaneous drainage in one case. Considering only severe complications (grade 3 or worse), no statistical difference was observed comparing the 2 groups (0/10 vs 2/20; p = 0.54). No patients undergoing 3D-LNSRH had pelvic dysfunctions not recovered/resolved at 30 days of follow-up. Three patients undergoing NSRH had persistent pelvic dysfunctions, including voiding dysfunction (n = 1), sexual dysfunction (n = 1), and voiding plus anorectal dysfunctions (n = 1).
Pelvic dysfunction rate for patients undergoing neoadjuvant chemotherapy plus nerve-sparing radical hysterectomy via 3D laparoscopic (3D-LNSRH) and open surgery (NSRH)
|3D-LNSRH (n = 10), n||NSRH (n = 20), n (%)||p Value|
|Pelvic dysfunction (not recovered at 30 days)||0||3 (15)||0.27|
|Bladder dysfunction at 30 days||0||2 (10)||0.53|
|Anorectal dysfunction at 30 days||0||1 (5)||1.00|
|Sexual dysfunction at 30 days||0||1 (5)||1.00|
The present investigation evaluated the impact of the implementation of 3D technology for the management of patients with locally advanced cervical cancer. First, we reported outcomes of 3D-LNSRH. Second, we observed that 3D laparoscopic technology allows a safe and effective execution of challenging gynecologic procedures like type C1 radical hysterectomy. Third, as expected, patients undergoing 3D-LNSRH experienced longer operative time, but lower estimated blood loss and shorter hospitalization than patients undergoing NSRH. Fourth, 3D-LNSRH correlates with a stable risk of developing severe postoperative events and voiding dysfunctions when compared with NSRH. However, we observed that, considering both moderate and severe events, patients undergoing surgery via laparoscopy had a trend towards lower complications rate than patients undergoing open surgery.
A growing number of investigations suggested the safety and long-term effectiveness of minimally invasive treatment of cervical cancer (18-19-20). In fact, although no level A evidence comparing minimally invasive with open surgery exists, accumulating evidence suggests the safety of laparoscopic and robotic-assisted approaches, even in the setting of locally advanced cervical cancer undergoing neoadjuvant chemotherapy (21, 22). However, for cervical cancer patients, the diffusion of minimally invasive approach occurred more slowly than expected.
During the present technological era of medicine, constant technical attempts are aimed to improve patient outcomes using new technologies. Similarly, laparoscopy is in a constant ongoing evolution. In particular, robotic-assisted surgery was developed to implement the widespread diffusion of less invasive surgical approaches, thus improving patient recovery and their standard of care (1-2-3-4). Owing to its relative intuitiveness and ease of use, the robotic platform allows surgeons to reduce the rate of unnecessary open surgeries. In fact, despite growing data supporting that laparoscopic overcomes robotic surgery, the former is characterized by a steep learning curve, especially for the execution of challenging procedures. The development of 3D laparoscopic technology will change procedures dramatically. This technology will allow surgeons to improve structure visualization and translate general surgical skills into laparoscopic ones.
Three points need comment. First, we evaluated the implementation of 3D laparoscopy for the surgical management of cervical cancer in patients with locally advanced disease. This represents the most appropriate population to show the beneficial effects of this new approach. Type C1 radical hysterectomy is a challenging operation. The correct visualization of the structures (i.e., nerves and vessels) surrounding the uterus is paramount to perform a safe dissection. This is the reason why in our department we started to perform this procedure only after the acquisition of 3D laparoscopic technology. Second, our results show that patients undergoing 3D-LNSRH experienced a trend towards lower urinary tract dysfunction than patients undergoing NRSH. The absence of standardized questionnaires and urodynamic testing may influence our results. However, we can speculate that the reduced surgical trauma and improved visualization of the nerves (due to the magnification of the images) might have a role in improving our surgical outcomes. Third, although our study is not aimed to assess surgery-related costs, we observed that after the implementation of 3D technology, there was a marked reduction of length of hospital stay (mean −2 days). Shorter hospitalization time improves patient turnover, thus potentially reducing costs and improving hospital workload.
The inherent biases of the prospective single-center study design and the small sample size represent the main weaknesses of the present investigation. However, this represents the first study on 3D-LNSRH and one of the larger studies reporting outcomes of laparoscopic nerve-sparing radical hysterectomy in patients with locally advanced cervical cancer undergoing neoadjuvant chemotherapy.
In conclusion, our study evaluated the safety and effectiveness of 3D-LNSRH. Our data show that the implementation of 3D laparoscopic technology allows the execution of challenging procedures, thus reducing open abdominal procedures rates. The introduction of 3D laparoscopic view into a preexisting clinical setting may improve patient outcomes and expand indications for laparoscopic utilization. Further large prospective studies are warranted in order to evaluate clinical effects of 3D laparoscopic technology.
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- Raspagliesi, Francesco [PubMed] [Google Scholar]
- Bogani, Giorgio [PubMed] [Google Scholar] , * Corresponding Author (email@example.com)
- Martinelli, Fabio [PubMed] [Google Scholar]
- Signorelli, Mauro [PubMed] [Google Scholar]
- Chiappa, Valentina [PubMed] [Google Scholar]
- Scaffa, Cono [PubMed] [Google Scholar]
- Sabatucci, Ilaria [PubMed] [Google Scholar]
- Adorni, Marco [PubMed] [Google Scholar]
- Lorusso, Domenica [PubMed] [Google Scholar]
- Ditto, Antonino [PubMed] [Google Scholar]
Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan - Italy