Robotic-assisted surgery: A systematic review of effectiveness and safety for elected indications and accumulating costs

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Research areas: High tech medicine, Health economics

Duration: May 2015 – November 2015
Publication: LBI-HTA Projektbericht No. 84: https://eprints.aihta.at/1077/

Language: German (with English summary)

Background:

Robotic-assisted 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 robotic-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 robotic-assisted surgery exist or not and if this benefit is proportional to the associated higher costs.

Aim of the project:

The first aim of the project is to provide a systematic analysis of the literature on the effectiveness and safety of robotic-assisted surgery for elected indications (e.g., nephrectomy or prostatectomy).

Furthermore, costs that occur from the perspective of hospital providers for robotic-assisted surgery will be compared with laparoscopic and open surgery.

Moreover, the future role of robotic-assisted surgery, especially for urological and gynaecological surgery, shall be evaluated.

Research questions:

  1. Is robotic-assisted surgery for the treatment of patients with an indication for operations in the area of the true pelvis (bladder, prostate, uterus, ovaries and kidneys) effective and safe with regard to defined outcomes (see PICO scheme) compared to laparoscopic or open surgery?
  2. What are the costs (acquisition, maintenance, etc.) of robotic-assisted surgery (considering the various products) from the perspective of hospital providers compared to laparoscopic and open surgery?
  3. What is the future of robotic-assisted surgery?

Inclusion criteria (PICO):

Population

Patients with indication for (with):

  • Nephrectomy (kidney cancer)
  • Adrenalectomy (adrenal cancer)
  • Prostatectomy (prostate cancer)
  • Cystectomy (bladder cancer)
  • Hysterectomy (benign or malign tumors of uterus)
  • Ovariectomy (ovarian cancer)

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

Control
  • Laparoscopic surgery
  • Open surgery

Outcomes

Effectiveness:

  • Mortality (disease-specific)
  • Rate of reoperations
  • Preservation continence (for prostatectomy and cystectomy)
  • Preservation erectile function (for prostatectomy)
  • 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.)

Costs:

  • For acquisition (acquisition, training, etc.)
  • For maintaining (maintaining, electricity, updating software, etc.)
  • duration of intervention / surgery

Types of studies

systematic reviews, meta-analyses, HTA reports, prospective (randomised) controlled studies with ? 10 patients (for effectiveness and safety), economic analyses

Publication period

1990-2015

Language

German/ English

Type of publication

published journal articles and research reports

 

Exclusion criteria:

Population:

  • animals

Types of studies

  • controlled studies with less than 10 patients
  • retrospective controlled studies
  • uncontrolled studies (like case reports, case series, single-arm studies, etc.)
  • editorials, letters to the editor, comments, other correspondence etc.

Types of publications

  • unpublished documents
  • abstracts, posters, comments, letters
  • 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: 1990-2015.
    • 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.
  • After effectiveness and safety of robotic-assisted surgery is proved, the costs will be estimated.
  • Assessment of the future role of robotic-assisted surgery by interviewing of physicians and by reviewing the literature.

Time schedule/ milestones:
 

Period

task

May 2015

scoping, precision of PICO-question

May - June 2015

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

July - September 2015

data extraction, synthesis and assessing of evidence, interview of physicians, drafting of report

September - November 2015

internal and external review, publication