Prospective Gallbladder Database STGAG
Organizational Data
- DRKS-ID:
- DRKS00033085
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2023-11-30
- Last update in DRKS:
- 2024-02-05
- Registration type:
- Prospective
Acronym/abbreviation of the study
GB-DB-TG
URL of the study
https://www.stgag.ch/fachbereiche/chirurgie/forschung/
Brief summary in lay language
Cholecystectomy represents the most important pillar of treating gallstone-associated diseases. High-quality surgical treatment must be ensured and quality must be measured. Therefore, all patients who are operated on in our center should be systematically recorded and the surgical efficiency and safety should be prospectively examined. This is the only way to ensure constant benchmarking and quality improvement.
Brief summary in scientific language
The primary objective is to gain data which allow a local surgical quality assurance and benchmarking in order to identify factors which can be improved. This is a long-term objective and therefore the project’s time-line is open. However, due to its exploratory character there is no formal hypothesis or primary endpoint.
Health condition or problem studied
- Free text:
- Benign diseases of the gallbladder or other diseases caused by gallstones
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Gallbladder surgery
Endpoints
- Primary outcome:
- Quality control and benchmarking
- Secondary outcome:
- Intraoperative endpoints Date of surgery Elective surgery or emergency operation For elective: Inpatient or outpatient Preoperative ERCP Operative time (Time from incision of skin until skin closure, in minutes) Intraoperative blood loss (measured in ml) Insertion of drainage (yes/no) Type of procedure Open resection Laparoscopic resection Robot-assisted Conversion to open resection Cholangiography (y/n) Obstruction of bile duct (y/n) Intervention due to obstruction Transcystic Fogarty catheter Choledochotomy Other Surgeon (Resident, Consultant (supervised or not), Senior surgeon) Identification of the critical view of safety possible (y/n) Documentation with Photo Closing of gallbladder artery With clips With coagulation With stapler Closing of gallbladder duct With clips With coagulation With stapler Intraoperative Complications Gallbladder perforation (=bile spilling) Lesion of common bile duct Strasberg classification Biliodigestive anastomosis (yes/no) Suture T-Drainage Stent Lesion of other intra-abdominal organ Bleeding with need of additional intervention (beamer, haemostyptic or other) Other complications Postoperative endpoints Postoperative complications (Clavien-Dindo classification) within 14 days, especially Postoperative hemorrhage Bile leakage Intra-abdominal fluid collection Choledocholithiasis Re-intervention rate Up to 14 days after surgery Re-operation rate Up to 14 days after surgery Surgical site infection (according to CDC definition) Pain on a numeric rating scale Evaluated at 4h, 48h, 14 days after Surgery Postoperative nausea and vomiting Evaluated at 4h, 48h, 14 days after Surgery Length of hospital stay (LOS, days from the day of the index operation until the day of hospital discharge; 0 = outpatient surgery) Prolonged hospitalization ((y/n; >2 days for inpatient and >0 for outpatient surgery) If yes, due to Pain Nausea and vomiting Bleeding Wound complications Social reasons Other Re-admission rate, up to 14 days after surgery If yes, due to Pain Nausea and vomiting Bleeding Wound complications Social reasons Other Visits to the emergency room after discharge, up to 14 days after surgery Date (which postoperative day) If yes, due to Pain Nausea and vomiting Bleeding Wound complications Social reasons Other Time to return to work (in days) Evaluated at 14 days after surgery Histological examination The Gastrointestinal Quality of Life Index (GIQLI), 14 days after surgery Case costs First admission Income Expenses In case of readmission Income Expenses In case of mortality: reason and explanation
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- Prospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Longitudinal study
- Study type non-interventional:
- Patient Registry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Switzerland
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Chirurgie STGAG Frauenfeld
- Medical center Chirurgie STGAG Münsterlingen
Recruitment period and number of participants
- Planned study start date:
- 2024-08-01
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 9999
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- All patients undergoing a treatment for a benign disease of the gallbladder or other gallstone-associated diseases.
Exclusion Criteria
Malignant diseases.
Addresses
Primary Sponsor
- Address:
- Chirurgie STGAGPfaffenholzstrasse 48501 FrauenfeldSwitzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Chirurgie STGAGProf. Dr. med. Pascal ProbstPfaffenholzstrasse 48501 FrauenfeldSwitzerland
- Telephone:
- +41 58 144 7241
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Chirurgie STGAGProf. Dr. med. Pascal ProbstPfaffenholzstrasse 48501 FrauenfeldSwitzerland
- Telephone:
- +41 58 144 7241
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Chirurgie STGAGProf. Dr. med. Pascal ProbstPfaffenholzstrasse 48501 FrauenfeldSwitzerland
- Telephone:
- +41 58 144 7241
- 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:
- Chirurgie STGAGPfaffenholzstrasse 48501 FrauenfeldSwitzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission Ostschweiz (EKOS)Scheibenackerstrasse 49000 St. GallenSwitzerland
- Telephone:
- +41 58 411 28 95
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.sg.ch/gesundheit-soziales/gesundheit/gremien.html
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-10-26
- Ethics committee number:
- 2023-01967
- Vote of the Ethics Committee:
- No approval required according to the EC
- Date of the vote:
- 2023-11-02
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:
- Surgical researchers can make a request to have the data made available. Both the patient data and all supporting information (e.g. study protocol, statistical analysis plan etc.) can be applied for. For this purpose, a written request must be made to the primary investigator with a description of the research project for which the data is to be used. Possible analyzes that would be supported would be multi-center retrospective analyzes or IPD meta-analyses. However, the data will only be shared after the point in time at which they were primarily published by STGAG and a maximum of ten years after the data was recorded. If the study director decides to make the data available, they will be transmitted in a processable form and anonymously.
Study protocol and other study documents
- Study protocols:
- Protokoll für die Ethik, 2023
- 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