Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05853302 |
| Other study ID # |
4853 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2022 |
| Est. completion date |
September 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
Francesco Pennestrì, Dr |
| Phone |
+393280244528 |
| Email |
francesco.pennestri[@]policlinicogemelli.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This retrospective study evaluates the security and the effectiveness of robotic
adrenalectomy when compared to laparoscopic approach in patients who underwent
minimally-invasive lateral transperitoneal unilateral adrenalectomy.
Description:
During the last twenty years, minimally-invasive surgery became the first choice for the
surgical treatment of most of adrenal diseases. Such minimally-invasive techniques success in
mainly related to the significative post-operative morbidity reduction. Adrenalectomy is a
technical demanding procedure, requiring a cautious and precise dissection in the
retroperitoneal space, so that endoscopic magnification may represent an essential tool.
Several minimally-invasive approaches to adrenalectomy have been described, including
anterior and lateral laparoscopic or lateral and posterior retroperitoneal techniques.
Lateral transabdominal approach is the most frequently used for robotic adrenalectomy.
However, routinary use of robotic platforms is limitated by their high costs.
Laparoscopic adrenalectomy was described by Gagner at al. in 1992, by means of a lateral
transperitoneal approach. Several retrospective studies showed the advantages of laparoscopic
approach compared to laparotomic procedure, such as lower post-operative pain, morbidity and
hospital stay. Lateral transabdominal laparoscopic adrenalectomy is nowadays the most
frequently used technique. One of the main advantages is related to the possibility of using
the gravity effect during surgical dissection. Indeed, after the mobilization of the anatomic
structures next to the adrenal gland (liver on the right side and splenopancreatic block on
the left side), no more manipulations are necessary during the procedure. Moreover, this
approach guarantees a wide working space, with the exposure of conventional anatomic
landmarks, allowing an adequate vascular control. A further advantage consists of the
possibility of exploring the whole abdominal cavity, therefore permitting the treatment of
other surgical clinical conditions. Technically speaking, the main condition for the
procedure success is a complete knowledge of surgical anatomy and an adequate surgical
expertise, so that different approaches may be chosen basing on both patient's and lesion's
features.
In 1999 Piazza et al. and Hubens et al. described robotic approach to adrenalectomy by means
of AESOP 2000 platform. Then, "Da Vinci" platform (Intuitive Surgical, Sunnyvale, CA, USA)
was introduced in clinical practice. After that, robotic adrenalectomies have been performed
in several centers, proving the safety and feasibility of such procedure. "Da Vinci" platform
allowed to maintain the same advantages of minimally-invasive approaches, with a reduction of
the difficulties due to their technical limitations. Indeed, ergonomic superiority,
tridimensional vision, tremors reduction and major freedom degrees related to the robotic
instruments allow an easier surgical dissection.
Minimally-invasive adrenalectomy is the gold standard for the treatment of <6 cm adrenal
lesions. Feasibility of endoscopic adrenalectomy for the treatment of wider or suspected for
malignancy adrenal lesions still remains debated. National Institute of Health (NIH) Position
Statement showed that adrenal cortical carcinoma prevalence is directly related to the lesion
diameter, representing 2% of <4 cm lesions, 6% of 4,1-6 cm lesions and 25% of >6 cm lesions.
However, lesion diameter alone is a too aspecific factor to be considered the parameter of
choice of the surgical approach. Indeed, about 75% of >6 cm adrenal lesions result benign
after definitive histological examination. Furthermore, several works in literature showed
that the oncologic radicality of minimally-invasive approaches to localized malignant lesions
is not inferior comparing to conventional laparotomic procedures. However, European Society
of Endocrine Surgeon (ESES) and European Network for the Study of Adrenal Tumors (ENSAT) for
the treatment of adrenal lesions suggest that transperitoneal approach should be the
procedure of choice to guarantee optimal intraoperative stadiation, complete oncologic
resection, capsular effraction risk and verify loco-regional structures infiltration.
Most studies demonstrated that TLA is a safe and effective procedure with low morbidity and
mortality rates. Post-operative complications rates are not easy to interpretate due to the
lack of standardization among the studies, though their range could be assessed between 2.9
and 15.5%. Complications and conversions risk factors, such as surgeon's expertice and
center's volume, patient's anatomical characteristics and lesion's features, have been
evaluated in monocentric and multicentric studies. More precisely, volume center and surgical
expertise impact on clinical outcome have been demonstrated in several studies. Park et al.
published a retrospective analysis of 344 adrenalectomies and documented a major
complications rate (18.3 vs 11.3%) and a longer hospital stay (5.5 vs 3.9 days) in those
procedures performed in center with low volume. Also, Palazzo et al. showed a significative
increase in hospital stay and readmission within 30 days in low volume centers. Bergamini et
al. identified age, BMI, lesion diameter and catecholaminergic secretion as risk factors for
complications, with low complications rates in referral centers.
Among patients' characteristics, the major risk factors for complications and conversions
were obesity, history of abdominal surgery, lesion side, patients comorbidity and
catecholaminergic secretion. Obesity (BMI≥30 Kg/m2) has been reported as a risk factor for
post-operative complications. However, more recently such conditions turned to be associated
only to an operative time increasing. History of abdominal surgery has been also reported as
a risk factor for intra- and post-operative complications. However, recent case series proved
that TLA performed after previous abdominal surgery did not lead to major conversion and
complications rates. Lesion diameter has been evaluated in several experiences as
complications risk factor, with different dimensional cut-off. An higher post-operative
complications rate have been reported in patients with lesions >60 mm. However, other studies
with different cut-off (60-80 mm) did not confirm such results.
To date, conversion rate to laparotomic surgery set to a median of 2%, with a range of 0-13%.
Vascular and organs' lesions, as well as the technical difficulties, are the most frequent
causes of conversion.
The TLA-related reported mortality is 0-0.8%. The most frequent causes of death are massive
bleeding, pancreatitis, pulmonary embolism and sepsis.
Systematic reviews and meta-analysis showed the safety and effectiveness of the robotic
approach to adrenalectomy. The reported operative times are different among the published
works in literature, with median values of 98-234 minutes. Brunaud et al. identified some
criteria that might influence the operative times, such as surgeon's expertise, the assistant
training level, lesion diameter (with lower times in case of lesion<45 mm). Longer operative
times are tipically associated with the beginning of the surgical experience and may be
related to the docking. However, in referral centers with high experience in endoscopic
adrenal surgery, docking times are significantly reduced after the learning curve is
completed. In our experience, docking time requires about 10 minutes to be completed. Blood
loss and hospital stay length are generally considered comparable to TLA. However, several
authors report less blood loss and shorter hospital stay in case of robotic adrenalectomy.
Robotic surgery conversion rates to the laparoscopic and laparotomic approach vary between 0%
- 40% and 0% - 10%, respectively. Conversion-related conditions are adhesions, bleeding and
technical difficulties. Retrospective series and meta-analysis confirmed that laparoscopic
and robotic morbidity and mortality rates are comparable. High costs still represent a
limitation of robotic procedures. Brunaud et al. evidenced 2.3 times higher costs for robotic
approach. Total costs are proportional to total procedures per year and to instruments costs,
while operative time has a marginal role. Similar results have been published by Morino et
al. Some authors achieved different results, as costs analysis was influenced by the specific
health system reimbursement. In De Crea et al. cost-analysis 131 patients who underwent
adrenalectomy between January 2017 and September 2019 (39 PRA, 80 TLA and 12 RA) have been
compared. Cost-analysis considered Italian Health system reimbursement basing on Diagnosis
Related Group (DRG). All the procedures, including RA, presented positive marginality, with
comparable values between PRA and TLA, superior to RA in both cases. Thoughout a subgroups
analysius, marginality difference between RA and the other approaches was reduced of 20% in
case of lesion >4 cm. The results confirmed that RA may present advantages in case of
challenging cases, such as obese patients or large lesions.
