Creation of a standard dataset for hand-sewn gastrojejunostomy in laparoscopic Roux-en-Y gastric bypass procedures
Organizational Data
- DRKS-ID:
- DRKS00030082
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-09-06
- Last update in DRKS:
- 2023-01-09
- Registration type:
- Prospective
Acronym/abbreviation of the study
STOPGAP
URL of the study
No Entry
Brief summary in lay language
Data science can help improve the quality of healthcare. However, there are not enough data with high quality. Thus, we need to create a standardized dataset including surgery videos to fill the gap.
Brief summary in scientific language
The Surgical data science (SDS) is a research field that aims to improve the quality of interventional healthcare by observing all aspects of the patient treatment process to provide the right assistance at the right time. To date, most SDS applications are based on the deep learning technique, which has shown great potential to solve challenging tasks in a complex surgical environment. However, such algorithms are dependent on a large amount of training data, which not only must contain data, but also labels (e.g., localization of an instrument in the image), so that they can be used for training. The application of data science in surgery has been far less successful than in other fields of science. An international consortium of experts has identified missing datasets as the major hurdle in enabling SDS. To create high-quality datasets, data needs to be collected according to strict acquisition protocols and annotated by trained personnel following strict annotation protocols. This requires significant effort and the access to expert knowledge represents a major bottleneck. By creating, curating and publishing a dataset for laparoscopic Roux-en-Y gastric bypass, an operation that requires performing intestinal anastomosis, we aim to facilitate the use of SDS methods in training and during operations. The collected data will be two-fold, consisting of (1) data deriving from training sessions and (2) real-life procedures in operating rooms (OR). Care will be taken to systematically capture and annotate perioperative data (Surgical team, skill level, patient data from the Electronic Health Record (EHR)), video clips of surgeons using standardized protocols that will be published together with the dataset. Modern tools will be used for annotation2, and algorithm specific metadata (Implementation, Version, Uncertainty, Training data used, etc.) will be collected and included in the dataset.
Health condition or problem studied
- ICD10:
- E66 - Obesity
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- observational study. The surgical phase of gastrojejunostomy is to be recorded and correlation with the outcomes (weight loss and complication such as dumping syndrome) 12 months after surgery will be investigated.
Endpoints
- Primary outcome:
- outcomes 12 months after surgery including weight loss, complications such aus dumping syndrome
- Secondary outcome:
- - total weight loss (%TWL) - excess weight loss (%EWL) - quality of life - Sigstad-score - postoperative morbidity
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- 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 Chirurgie Mannheim
Recruitment period and number of participants
- Planned study start date:
- 2022-09-08
- Actual study start date:
- 2022-09-08
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 200
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 100 Years
- Additional Inclusion Criteria:
- - Patients who are going to undergo a gastric bypass operation for obesity - Age ≥ 18 years - Written informed consent
Exclusion Criteria
- Patients with language barrier or impaired mental state - Expected lack of compliance
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum MannheimProf. Christoph ReißfelderTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 06213832225
- Fax:
- 06213831975
- 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:
- Chirurgische Klinik, Universitätsmedizin MannheimDr. Cui YangTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 00496213836416
- Fax:
- 00496213833809
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Chirurgische Klinik, Universitätsmedizin MannheimDr. Cui YangTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 00496213836416
- Fax:
- 00496213833809
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Chirurgische Klinik, Universitätsmedizin MannheimDr. Cui YangTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 00496213836416
- Fax:
- 00496213833809
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Ministerium für Wissenschaft, Forschung und Kunst Baden-WürttembergKönigstraße 4670173 StuttgartGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Medizinische Ethik-Kommission II Medizinischen Fakultät Mannheim, Forschungsgebäude, Haus 42 - Ebene 3Theodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49-621-38371770
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-04-25
- Ethics committee number:
- 2022-594
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-05-12
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?:
- Yes
- IPD Sharing Plan:
- the dataset will be published annonymously.
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