NCT06113796

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
Last Updated

November 2, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

October 4, 2023

Last Update Submit

November 1, 2023

Conditions

Rectal Cancer

Keywords

Robotic SurgeryRectal CancerLow anterior ResectionAbdominoperineal rectal extirpationEconomic analysis

Outcome Measures

Primary Outcomes (1)

  • Costs of treatment

    costs caused by the case

    1 year

Secondary Outcomes (3)

  • Major Complication

    30 days postoperatively

  • Length of Hospital Stay

    3 months

  • 30-days Readmission

    30 days

Study Arms (2)

Robotic sphincter-preserving rectal resection

Patients with robotic anterior or low anterior rectal resection and primary anastomosis for rectal cancer.

Other: Surgery

Robotic abdominoperineal rectal resection

Patients with robotic abdominoperineal rectal resection for rectal cancer.

Other: Surgery

Interventions

SurgeryOTHER

Robotic rectal resection, either sphincter preserving or extirpation

Robotic abdominoperineal rectal resectionRobotic sphincter-preserving rectal resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients operated robotically-assisted between 01/2018 and 12/2019 for rectal cancer are suitable for inclusion.

You may qualify if:

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

You may not qualify if:

  • no rectal cancer
  • primary open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hamburg Medical Institutions

Hamburg, Germany

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Daniel Perez, Prof.

    Department of General, Visceral and Thoracic Surgery, University Hospital Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2023

First Posted

November 2, 2023

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2021

Last Updated

November 2, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)