Rectal CancerNCT06113796
Economic Analysis of Robotic Rectal Resection in German Health Care System
An observational study of Rectal Cancer, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Analysis of cost effectiveness of robotic rectal resection, either sphincter preserving or abdominoperineal extirpation, in the German diagnosis related groups (DRG) system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Surgery
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2018to 31 Dec 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients operated robotically-assisted between 01/2018 and 12/2019 for rectal cancer are suitable for inclusion.
Who may be able to join
- 18y
- histologically proven rectal cancer with curative therapeutic approach
- suitable for minimally-invasive surgery
Who cannot join
- no rectal cancer
- primary open surgery
Trial locations and contacts
1 site in 1 country.
About this study
Analysis of cost effectiveness of robotic rectal resection, either sphincter preserving or abdominoperineal extirpation, in the German diagnosis related groups (DRG) system.
Read the detailed description
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.
- Conditions
- Rectal Cancer
- Being tested
- Surgery
- Keywords
- Robotic Surgery, Rectal Cancer, Low anterior Resection, Abdominoperineal rectal extirpation, Economic analysis
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
Robotic rectal resection, either sphincter preserving or extirpation
| Study group | Role | What they receive |
|---|---|---|
| Robotic sphincter-preserving rectal resection | Patients with robotic anterior or low anterior rectal resection and primary anastomosis for rectal cancer. Receives: Other: Surgery | |
| Robotic abdominoperineal rectal resection | Patients with robotic abdominoperineal rectal resection for rectal cancer. Receives: Other: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Costs of treatment
costs caused by the case
Measured: 1 year
Secondary outcomes (3)
Major Complication
Clavin Dindo Score ≥ 3
Measured: 30 days postoperatively
Length of Hospital Stay
Hospital Stay after Surgery
Measured: 3 months
30-days Readmission
Readmission within 30 days after Surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Perez, Prof., Principal investigator, Department of General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113796
- Sponsor's protocol ID
- UKE Hamburg 3
- Status last verified
- Nov 2023
- First submitted
- 4 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Analysis of Robotic Rectal Resection in German Health Care System
- ClinicalTrials.gov ID
- NCT06113796
- Acronym / sponsor ID
- UKE Hamburg 3
- Conditions
- Rectal Cancer
- Keywords
- Robotic Surgery, Rectal Cancer, Low anterior Resection, Abdominoperineal rectal extirpation, Economic analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Analysis of cost effectiveness of robotic rectal resection, either sphincter preserving or abdominoperineal extirpation, in the German diagnosis related groups (DRG) system.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic sphincter-preserving rectal resection | – | Other: SurgeryPatients with robotic anterior or low anterior rectal resection and primary anastomosis for rectal cancer. |
| Robotic abdominoperineal rectal resection | – | Other: SurgeryPatients with robotic abdominoperineal rectal resection for rectal cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients operated robotically-assisted between 01/2018 and 12/2019 for rectal cancer are suitable for inclusion.
Key inclusion criteria (3 listed)
- 18y
- histologically proven rectal cancer with curative therapeutic approach
- suitable for minimally-invasive surgery
Key exclusion criteria (2 listed)
- no rectal cancer
- primary open surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryRobotic rectal resection, either sphincter preserving or extirpation | Other | Robotic abdominoperineal rectal resection, Robotic sphincter-preserving rectal resection |
Primary outcome
Costs of treatment
Time frame: 1 year
costs caused by the case
3 secondary outcomes
Major Complication
Time frame: 30 days postoperatively
Length of Hospital Stay
Time frame: 3 months
30-days Readmission
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Perez, Prof. principal investigator
Department of General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Costs of treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.