A prospective phase II clinical trial/IDEAL Stage 2a series of single‐port robotic colorectal surgery for abdominal and transanal cases

Author:

Marks John H.1,Yang Jane2,Spitz Elizabeth M.3,Salem Jean4,Agarwal Samir5,de Paula Thais Reif3,Schoonyoung Henry P.1,Keller Deborah S.1ORCID

Affiliation:

1. Lankenau Institute for Medical Research and Division of Colon and Rectal Surgery, Department of Surgery Lankenau Medical Center Wynnewood Pennsylvania USA

2. Division of Colon and Rectal Surgery, Department of Surgery Lankenau Medical Center Wynnewood Pennsylvania USA

3. Lankenau Institute for Medical Research Lankenau Medical Center Wynnewood Pennsylvania USA

4. Department of Surgery Saline Health System Benton Arkansas USA

5. Department of Surgery, Physician First Group Sarasota Memorial Health Care System Sarasota Florida USA

Abstract

AbstractAimSlow laparoscopy adoption accelerated the uptake of robotic surgery. However, the current robotic platforms have limitations in transanal applications and multiple port sites. The da Vinci single‐port (SP) robot is currently used on trial for colorectal surgery, and broad assessment of outcomes is needed. We aimed to report findings of a phase II clinical trial of SP robotic colorectal surgery.MethodsA sequentially reported prospective case series was performed on patients using SP robotics at a tertiary referral centre from 1 October 2018 to 31 August 2021. Cases were stratified into abdominal and transanal cohorts. Demographics, intra‐operative variables and 30‐day postoperative outcomes were evaluated. Univariate analysis was performed, with statistical process control for the docking process. Main outcomes were conversion rates, morbidity, mortality and point of standardization of docking.ResultsIn all, 133 patients were included: 93 (69.92%) abdominal and 40 (30.08%) transanal. The main diagnosis was rectal cancer (n = 59) and the procedure performed a robotic transanal abdominal transanal radical proctosigmoidectomy (n = 30). There were no conversions to open surgery. Two abdominal (2.15%) and three transanal cases (7.50%) were converted to laparoscopy. All colorectal adenocarcinomas had negative margins, proper lymph node harvest and complete mesorectal excision, as appropriate. Docking became a standardized process at cases 34 (abdominal) and 23 (anorectal). After surgery, bowel function returned on mean day 2 (abdominal) and 1 (transanal). The morbidity rate was 15.05% (abdominal) and 27.50% (transanal). There were two major morbidities in each cohort. Overall, there were three (2.65%) readmissions, one reoperation and no mortality.ConclusionsSingle‐port robotics is feasible for all types of colorectal procedures, with good clinical and oncological outcomes. With this development in colorectal surgery, further studies can develop best practices with this novel technology.

Publisher

Wiley

Subject

Gastroenterology

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