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Completed

NCT Number: NCT06113796

Economic Analysis of Robotic Rectal Resection in German Health Care System

Analysis of cost effectiveness of robotic rectal resection, either sphincter preserving or abdominoperineal extirpation, in the German diagnosis related groups (DRG) system.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Hamburg Medical Institutions

Hamburg, Germany

About this study

Robotic surgery has many well-known benefits for patients and surgeons, while it comes with higher acquisition and maintenance costs. On the other hand, a higher proportion of minimally invasive procedures can save costs by reducing complications, decreasing hospital stays due to lower morbidity, and saving personnel.

To what extent can robotic surgery be cost-covering or even profitable, depending on the postoperative course? This question is investigated under the conditions of the German DRG system.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18y
  • histologically proven rectal cancer with curative therapeutic approach
  • suitable for minimally-invasive surgery

Exclusion criteria

  • no rectal cancer
  • primary open surgery

Treatment and study plan

SURGERY

Other

Robotic rectal resection, either sphincter preserving or extirpation

Primary outcomes

  1. Costs of treatment

    Time frame: 1 year

    costs caused by the case

Secondary outcomes

  1. Major Complication

    Time frame: 30 days postoperatively

    Clavin Dindo Score ≥ 3

  2. Length of Hospital Stay

    Time frame: 3 months

    Hospital Stay after Surgery

  3. 30-days Readmission

    Time frame: 30 days

    Readmission within 30 days after Surgery

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Nov 2, 2023
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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