Patient-specific 3D Liver model- based patient information for liver surgery

• Conditions: C22; C23; C24; K74; K75; K76; Malignant neoplasm of liver and intrahepatic bile ducts; Malignant neoplasm of gallbladder; Malignant neoplasm of other and unspecified parts of biliary tract; Fibrosis and cirrhosis of liver

• Registration Number: DRKS00022397
• Lead Sponsor: Technische Universität Dresden

Brief Summary

Results The study population (n = 40) was predominantly of male gender (62.5%) with a median age of 65.2 years and a high prevalence of preexisting diseases. Underlying disease, warranting hepatobiliary surgery, was malignancy in the majority of cases (97.5%). Patients in the 3D-LiMo group were more likely to feel very thoroughly educated and exhibited a higher level of satisfaction following surgical education than the control group (80 vs. 55%, n.s.; 90 vs. 65%, n.s.; respectively). Applying 3D models was also associated with enhanced understanding of the underlying disease with regard to amount (100% vs. 70%, p = 0.020) and location of liver masses (95 vs. 65%, p = 0.044). 3D-LiMo patients also demonstrated enhanced understanding of the surgical procedure (80 vs. 55%, n.s.), leading to better awareness for the occurrence of postoperative complications (88.9, vs. 68.4%, p = 0.052). Adverse event profiles were similar. Conclusion In conclusion, individual 3D-printed liver models increase patient satisfaction with surgical education and facilitate patients’ understanding of the surgical procedure as well as awareness of postoperative complications. Therefore, the study protocol is feasible to apply to an adequately powered, multicenter, randomized clinical trial with minor modifications.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-08
• Study Completion: 2022-04-04
• Results First Posted: 2023-02-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Indication for liver resection
- Preoperative imaging in the form of a KM-CT or -MRT available

Exclusion Criteria

- speech problems or impaired mental state
- missing compliance

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient satisfaction immediately after operation information has been provided

Secondary Outcome Measures

Name	Time	Method
- Patient satisfaction postoperatively 0-2 days before discharge<br><br>- Patient satisfaction postoperatively after 4-12 weeks<br><br>- Duration of surgery<br><br>- Conversion rate for laparoscopic operations<br><br>- Postoperative blood transfusion<br><br>- Postoperative morbidity (within the hospital stay and up to 3 months postoperatively)<br><br>- postoperative mortality (within the hospital stay and up to 3 months)<br><br>- Reoperation rate<br><br>- Postoperative intervention rate (CT-guided puncture)<br><br>- Postoperative ITS stay<br><br>- Postoperative ventilation days<br><br>- Postoperative hospital stay