Robot-assisted surgery: A systematic review of effectiveness and safety in thoracic and visceral surgery

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Research area: High tech medicine

Project leaders: Claudia Wild

Project team: Lucia Gassner, Nicole Grössmann-Waniek

and Michaela Riegelnegg 
Duration: April 2023 – August 2023
Language: English (with German summary)

Publication: HTA Project Report No. 108: https://eprints.aihta.at/1461

Background: Robot-assisted or robotic surgery was developed during the past 25 years to support surgeons performing minimally invasive operations. The use of robots is intended to increase the precision of the intervention and reduce complications, resulting in shorter hospital stays combined with better treatment effects. However, the costs of robot-assisted surgery – for acquisition and maintenance - seem to be linked with higher costs compared to laparoscopic or open surgery. It is unclear whether a crucial benefit of robot-assisted surgery exists or not.

Aim of the project: The project aims to provide a systematic analysis of the literature on the effectiveness and safety of robot-assisted surgery in thoracic and visceral surgery.

Research question: Is robot-assisted surgery for treating patients with an indication for operations in the area of the thorax and abdomen effective and safe with regard to defined outcomes (see PICO scheme) compared to laparoscopic or open surgery?

Inclusion criteria (PICO):

Population

Patients with indication for thoracic surgery:

  • Pulmonary (sleeve) lobectomy (non-small cell lung cancer)
  • Lung segmentectomy / wedge resection (non-small cell lung cancer)
  • Pneumonectomy (non-small cell lung cancer)
  • Mediastinal surgery (mediastinal tumour, mediastinal bronchogenic cyst)
  • Pleurectomy (Malignant / recurrent pleural effusions; mesothelioma; recurrent pneumothorax)
  • Thymectomy (Myasthenia gravis (pseudoparalytica); thymoma)
  • Pleural/pulmonary decortication (pleural empyema)

Patients with indication for visceral (abdominal) surgery:

  • Anti-reflux surgery (gastroesophageal reflux disease (e.g. Nissen fundoplication))
  • Oesophagectomy (oesophageal cancer)
  • Oesophageal repair (oesophageal perforation)
  • Gastrectomy (subtotal for gastric cancer <stage IB, radical for IB-III)
  • Bariatric surgery (obesity (e.g. ROUX-en-Y gastric bypass,  gastric bypass, and sleeve gastrectomy))
  • Small bowel resection (bleeding, infection, ulcers, blockage, benign tumours, precancerous polyps, cancer, injuries, Meckel’s diverticulum)
  • Colectomy (bleeding, bowel obstruction, cancer, Crohn’s disease, ulcerative colitis, diverticulitis, cancer prevention (e.g. total colectomy, partial colectomy, hemicolectomy, and proctocolectomy))
  • Rectal resection (rectal cancer (e.g. polypectomy, and local excision))
  • Appendectomy (appendicitis)
  • Pancreatectomy (inflammation, trauma, neoplasms)
  • Hernia Repair (hernia)
  • Myotomy (achalasia)
  • Cholecystectomy (biliary colic, acute cholecystitis, cholangitis (e.g. caused by symptomatic gallstones), gallbladder cancer)

Intervention, Setting
  • Robot-assisted surgery (several products)

Control
  • Laparoscopic surgery
  • Open surgery

Outcomes

Effectiveness:

  • Mortality (disease-specific)
  • Rate of reoperations
  • Other disease-specific effectiveness-related outcomes
  • Quality of life
  • Duration of hospital stay
  • Time to resume work / daily activities
  • Patient satisfaction

Safety:

  • Intraoperative complications (bleeding, mortality, etc.)
  • Postoperative complications (pain, infections, etc.)

Types of studies

Randomised controlled studies (RCTs) with >20 patients (for effectiveness and safety)

Publication period

26.06.2018 – 04.2023

Language

German, English

Type of publication

published journal articles and research reports

Exclusion criteria:
Population:

  • Animals
  • Patients with indication for:
    • Cardiothoracic surgeries
    • Mediastinoscopy, Pleuroscopy and Thorascopy (e.g. for diagnosis)
    • Thoracotomy (without any further intervention, e.g. lung resection)
    • Relaparotomy (without any further intervention)

Outcomes:

  • Any outcomes that are not directly patient-relevant (such as blood loss, operation time or transfusions)

Types of studies

  • controlled studies with ?20 patients
  • prospective and retrospective non-randomised controlled studies
  • retrospective controlled studies
  • uncontrolled studies (like case reports, case series, single-arm studies, etc.)
  • HTA reports and systematic reviews (these documents will partly be considered as background literature)

Types of publications

  • unpublished documents
  • (conference) abstracts, posters, letters
  • books
  • editorials, letters to the editor, comments, other correspondence etc.

Methods:

Systematic review based on published documents:

  • Systematic literature search for RCTs:
    • Databases: Medline and Cochrane Library (time period: 26.06.2018 – 04.2023)
  • Two review authors include and exclude studies independently from each other. Data extraction and quality assessment: One author extracts the data and assesses the studies, while a second author controls it.
  • Quality assessment: assessing risk of bias (study level) and strength of evidence according to the Cochrane Risk of Bias tool Version 1 and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach
  • Clustering of evidence according to the indications
  • Synthesis

Time schedule/ milestones:

Period

task

April 2023

scoping, project protocol (German/English), systematic literature search in two databases, data extraction of pre-identified studies

Mai 2023

literature selection and acquisition, data extraction, risk of bias assessment and control

Juni – Juli 2023

risk of bias assessment and control, GRADE assessment and control, synthesis of evidence, drafting report

August 2023

drafting report, internal and external review, revision and layout, finalisation, publication

References:

Feng, Qingyang et al. “Robotic versus laparoscopic abdominoperineal resections for low rectal cancer: A single-center randomized controlled trial.” Journal of surgical oncology vol. 126,8 (2022): 1481-1493. doi:10.1002/jso.27076

Jin, Runsen et al. “Health-Related Quality of Life Following Robotic-Assisted or Video-Assisted Lobectomy in Patients With Non-Small Cell Lung Cancer: Results From the RVlob Randomized Clinical Trial.” Chest, S0012-3692(23)00015-6. 5 Jan. 2023, doi:10.1016/j.chest.2022.12.037

Patel, Yogita S et al. “RAVAL trial: Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer.” PloS one vol. 17,2 e0261767. 2 Feb. 2022, doi:10.1371/journal.pone.0261767

Petro, Clayton C et al. “Robotic vs Laparoscopic Ventral Hernia Repair with Intraperitoneal Mesh: 1-Year Exploratory Outcomes of the PROVE-IT Randomized Clinical Trial.” Journal of the American College of Surgeons vol. 234,6 (2022): 1160-1165. doi:10.1097/XCS.0000000000000171

Ribeiro, Ulysses Jr et al. “Short-Term Surgical Outcomes of Robotic Gastrectomy Compared to Open Gastrectomy for Patients with Gastric Cancer: a Randomized Trial.” Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract vol. 26,12 (2022): 2477-2485. doi:10.1007/s11605-022-05448-0

Terra, Ricardo Mingarini et al. “A Brazilian randomized study: Robotic-Assisted vs. Video-assisted lung lobectomy Outcomes (BRAVO trial).” Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia vol. 48,4 e20210464. 8 Jul. 2022, doi:10.36416/1806-3756/e20210464

Yang, Yang et al. “Robot-assisted Versus Conventional Minimally Invasive Esophagectomy for Resectable Esophageal Squamous Cell Carcinoma: Early Results of a Multicenter Randomized Controlled Trial: the RAMIE Trial.” Annals of surgery vol. 275,4 (2022): 646-653. doi:10.1097/SLA.0000000000005023