Open versus robot-assisted radical cystectomy: pentafecta and trifecta achievement comparison from a randomised controlled trial

Objectives

To compare University of Southern California (USC) Institute of Urology pentafecta and trifecta achievement comparing open radical cystectomy (ORC) vs robot-assisted RC (RARC) with totally intracorporeal urinary diversion (iUD) from a randomised controlled trial (RCT).

Patients and Methods

Patients were eligible for randomisation if they had a diagnostic transurethral resection of bladder tumour with clinical T stage (cT)2–4, cN0, cM0, or recurrent high-grade non-muscle-invasive bladder cancer and no anaesthesia contraindications to robotic surgery. Patients were enrolled with a covariate adaptive randomisation process based on the following variables: body mass index, American Society of Anesthesiologists score, preoperative haemoglobin, planned UD, neoadjuvant chemotherapy, and cT stage. USC pentafecta was defined as the combination at 1 year after surgery of: negative soft tissue surgical margins, ≥16 lymph node (LN) yield, absence of major (Clavien–Dindo Grade ≥III) complications at 90 days, absence of UD-related long-term sequalae, and absence of clinical recurrence. Trifecta was defined as the coexistence of daytime urinary continence, absence of major complications and recurrence-free status, all assessed at 1 year. Continuous and categorical variables were compared using Student's t-test and chi-square test, respectively. Univariable logistic regression analysis was performed to assess the role of USC pentafecta and trifecta achievement on health-related quality of life (HRQoL).

Results

There was no statistically significant difference in USC pentafecta and trifecta achievement between groups. Among secondary outcomes, univariable logistic regression analysis was performed and both 1-year USC pentafecta and trifecta achievement were predictors of 2-year unmodified global HRQoL.

Conclusions

This study supports equivalence of RARC-iUD and ORC with regard to surgical quality as described by the USC pentafecta and trifecta. We described a significant impact of USC pentafecta and trifecta achievement on global health status/HRQoL, providing a strict correlation between objective evaluation of surgical outcomes and self-reported HRQoL.     

多模式镇痛在达芬奇机器人辅助根治性膀胱全切除联合原位回肠新膀胱术中的应用

目的探讨多模式镇痛在达芬奇机器人辅助根治性膀胱全切除联合原位回肠新膀胱术中的应用价值。方法择期行达芬奇机器人辅助根治性膀胱全切除联合原位回肠新膀胱术中的患者60例,根据前后顺序分为2组(n=30),多模式镇痛组和对照组。多模式镇痛组的镇痛方案具体为:(1)帕瑞昔布钠的静脉使用;(2)腹横肌平面阻滞;(3)无阿片类药物的静脉镇痛泵。对照组只使用传统静脉镇痛泵。观察两组患者术后疼痛评分、镇痛相关不良反应发生率以及术后康复情况。结果 M组术后2 h、6 h、12 h、24 h、48 h疼痛评分明显低于对照组。多模式镇痛组术后恶心、呕吐、嗜睡、低血压发生率、追加止痛药及追加止呕药发生率均低于对照组。多模式镇痛组术后下床活动时间、排气时间、排便时间、住院时间明显早于对照组。结论多模式镇痛能有效减轻行达芬奇机器人辅助根治性膀胱全切除联合原位回肠新膀胱术患者的术后疼痛,促进早期下床活动,有利于患者术后康复,缩短住院时间。     

Haemodynamic and respiratory perioperative outcomes for open versus robot-assisted radical cystectomy: A double-blinded,randomised trial

Background

The clinical impact of prolonged steep Trendelenburg position and CO₂ pneumoperitoneum during robot-assisted radical cystectomy (RC) on intraoperative conditions and immediate postoperative recovery remains to be assessed. The current study investigates intraoperative and immediate postoperative outcomes for open RC (ORC) versus robot-assisted RC with intracorporal urinary diversion (iRARC) in a blinded randomised trial. We hypothesised that ORC would result in a faster haemodynamic and respiratory post-anaesthesia care unit (PACU) recovery compared to iRARC.

Methods

This study is a predefined sub-analysis of a single-centre, double-blinded, randomised feasibility study. Fifty bladder cancer patients were randomly assigned to ORC (n = 25) or iRARC (n = 25). Patients, PACU staff, and ward personnel were blinded to the surgical technique. Both randomisation arms followed the same anaesthesiologic procedure, fluid treatment plan, and PACU care. The primary outcome was immediate postoperative recovery using a standardised PACU Discharge Criteria (PACU-DC) score. Secondary outcomes included respiration- and arterial O₂ saturation scores as well as perioperative interventions and recordings.

Results

All patients underwent the allocated treatment. The total PACU-DC score was highest 6 h postoperatively with no difference in the total score between randomisation arms (p = 0.80). Both the ORC and iRARC groups maintained a mean respiration- and arterial O₂ saturation score below 1 (out of 3) throughout PACU stay. The iRARC patients had significantly, but clinically acceptable, higher maximum airway pressure and arterial blood pressure, as well as lower minimum pH levels. The ORC group received significantly more opioids after extubation but marginally less analgesics in the PACU, compared to the iRARC group.

Conclusions

A prolonged Trendelenburg position and CO₂ pneumoperitoneum was well-tolerated during iRARC, and immediate postoperative recovery was similar for ORC and iRARC patients.     

Robotic vs open radical cystectomy: prospective comparison of perioperative outcomes and pathological measures of early oncological efficacy

OBJECTIVE

To prospectively compare perioperative and pathological outcomes in a consecutive series of patients undergoing radical cystectomy (RC) and urinary diversion by the open or the robotic approach.

PATIENTS AND METHODS

From February 2006 to April 2007, 54 consecutive patients underwent RC by one surgeon at our institution. Twenty‐one were open, while 33 utilized the da Vinci robotic system (Intuitive Surgical, Sunnyvale, CA, USA). Data was collected prospectively, including patient demographics, operative and postoperative variables, and pathological outcomes.

RESULTS

The robotic cohort had decreased blood loss (400 vs 750 mL, P = 0.002) and transfusion requirement (2.0 vs 0.5 units, P = 0.007), but increased operative duration (390 vs 300 min, P = 0.03). The time to resumption of a regular diet (4 vs 5 days, P = 0.002) and the hospital stay (5 vs 8 days, P = 0.007) were decreased in the robotic group. Overall the complication rates were similar (24% open, 21% robotic, P = 0.3). The open cohort had more patients with extravesical disease (57 vs 28%, P = 0.03) and nodal metastasis (34 vs 19%, P = 0.04). There were three patients in the open group and two in the robotic with positive margins (P = 0.2). The median number of lymph nodes removed was similar in the open and robotic cohorts (20 vs 17, P = 0.6).

CONCLUSION

Robotic‐assisted RC appears to offer some operative and perioperative benefits compared with the open approach without compromising pathological measures of early oncological efficacy, such as lymph node yield and margin status. Larger, randomized studies with long‐term follow‐up are required to confirm these findings and establish oncological equivalence.