Role functioning in Robotic assisted versus laparoscopic liver resection
Organizational Data
- DRKS-ID:
- DRKS00027531
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2022-02-04
- Last update in DRKS:
- 2024-01-05
- Registration type:
- Prospective
Acronym/abbreviation of the study
Roc'n'Roll
URL of the study
No Entry
Brief summary in lay language
In minimally invasive liver surgery (MILS), robotic-assisted surgery is an emerging speciality which allows surgeons to perform more precise movements with enhanced dexterity and delicate dissection compared to conventional laparoscopic techniques. However, there is currently no randomized controlled trial existing to compare the health-related quality of life (HRQoL) as primary outcome in patients treated by MILS for primary and secondary liver malignancies. The Roc’n’Roll trial aims to compare the postoperative HRQoL during 90 days after surgery after laparoscopic and robotic-assisted liver resections.
Brief summary in scientific language
The current evidence comparing laparoscopic versus robotic liver resections is limited on cohort studies and there is no data extending on HRQoL after robotic surgery. As robotic-assisted surgery might result in a more precise surgery with enhanced recovery of patients and improved HRQoL after liver resection, the present trial aims to compare the HRQoL after robotic-assisted versus laparoscopic liver surgery for primary and secondary liver malignancies.
Health condition or problem studied
- ICD10:
- C22 - Malignant neoplasm of liver and intrahepatic bile ducts
- ICD10:
- C78.7 - Secondary malignant neoplasm of liver and intrahepatic bile duct
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Robotic-assisted liver resection
- Arm 2:
- Laparoscopic liver resection
Endpoints
- Primary outcome:
- Changes of quality of life measures within 90 days after surgery using the EORTC QLQ-C30 questionnaire "role functioning" item (at postoperative day 30, 60, and 90)
- Secondary outcome:
- Operating time, Blood loss, Postoperative morbidity and mortality, Conversion rate to open surgery, time-to-functional recovery, Pathological Characteristics, Costs
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Department of Surgery, Universitätsmedizin Mannheim, Heidelberg University Medical Faculty Mannheim Mannheim
Recruitment period and number of participants
- Planned study start date:
- 2022-02-20
- Actual study start date:
- 2022-02-14
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2023-12-18
- Target Sample Size:
- 90
- Final Sample Size:
- 81
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- 1. Age equal to or greater than 18 years 2. Curative-intent minimally invasive (robotic-assisted or laparoscopic) liver surgery for confirmed or suspected primary or secondary malignancies 3. Written informed consent 4. Ability and willingness to respond questionnaires
Exclusion Criteria
1. ASA ≥ 4 2. Impaired mental state or incompetence of understanding the German language (no fluent German language speaker) 3. Expected lack of compliance
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum MannheimTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umm.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universität Heidelberg, Medizinische Fakultät Mannheim, Chirurgische KlinikPD Dr. Emrullah BirginTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49 621 383 1501
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universität Heidelberg, Medizinische Fakultät Mannheim, Chirurgische KlinikPD Dr. Emrullah BirginTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49 621 383 3671
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Universität Heidelberg, Medizinische Fakultät Mannheim, Chirurgische KlinikPD Dr. Emrullah BirginTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49 621 383 1501
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum MannheimTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umm.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission II der Universität Heidelberg, Medizinische Fakultät MannheimTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49-621-38371770
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umm.uni-heidelberg.de/forschung/ethikkommission-ii/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-11-17
- Ethics committee number:
- 2021-672
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-01-25
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry