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

Fotolia-76406533-l
Research area: High tech medicine

Project leaders: Claudia Wild

Project team: Louise Schmidt (Joanneum Research)
& Anna Cavazzana
Duration: May 2018 – February 2019
Suggested by: Representatives of federal states
Language: English (with German summary)
Publication: LBI-HTA Project report No. 108: https://eprints.aihta.at/1198/

 

Background:
Robot-assisted or robotic surgery was developed during the past 20 years to support surgeons in 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 a 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 aim of the project is to provide a systematic analysis of the literature on the effectiveness and safety of robot-assisted surgery in thoracic and visceral surgery.

Research question:

  1. Is robot-assisted surgery for the treatment of 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)
  • Batriatic 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, cholangitits (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 ? 10 patients (for effectiveness and safety), and non-randomised controlled trials in the event of missing RCTs

Publication period

1990-2018

Language

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 less than 10 patients
  • 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
  • abstracts, posters, letters
  • editorials, letters to the editor, comments, other correspondence etc.
  • books

Methods:

Systematic Review based on published documents:

  • Systematic literature search in:
    • Cochrane (CENTRAL), Centre for Research and Dissemination (CRD), Embase, Medline and NHS Economic Evaluation Database. Time period: 1990-2018.
    • Handsearch in references (as appropriate via Scopus), internet-search, contacting manufacturers.
  • Data extraction: Two review authors include and exclude studies, independently from each other. One author extracts the data and a second author controls the extracted data.
  • Assessing risk of bias and strength of evidence: according to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

Time schedule/ milestones:

Period

task

May 2018

scoping, precision of PICO-question

May - June 2018

systematic literature search, non-systematic hand search, literature selection

July - September 2018

data extraction, synthesis and assessing of evidence drafting of report

October - November 2018

internal and external review, publication