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Preoperative planning based on 3D visualization and 3D printing technology was applied in a randomized controlled study of abdominal wall repair and reconstruction

Preoperative planning based on 3D visualization and 3D printing technology was applied in a randomized controlled study of abdominal wall repair and reconstruction

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052670
Enrollment
Unknown
Registered
2021-11-03
Start date
2021-12-01
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex abdominal wall defect

Interventions

Experimental group:3D visualization and 3D printing are used for preoperative planning
Control group:Routine imaging preoperative planning

Sponsors

Huadong Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Inpatients who signed informed consent; 2. There is no gender limit, aged 18 to 75 years (including 18 years old and 75 years old); 3. Patients with complex abdominal wall defect who meet any of the following conditions: (1) Giant abdominal wall defect (defect width >=10cm), abdominal wall defect with abdominal wall insufficiency (loss of domain, LOD), abdominal wall defect in special parts such as the suprapubic bone and the lower costal margin; (2) Accompanied by pollution or infection, after extended abdominal wall tumor resection, severe trauma, after multiple operations, after skin grafting, with ulcers or refractory wounds, and with abdominal wall defects next to stoma or fistula; (3) Associated with various risk factors, such as obesity, diabetes, chronic obstructive pulmonary disease, massive ascites, use of steroid hormones, poor nutritional status and other diseases, with a history of incision dehiscence, repaired by patch or tissue structure separation techniques Recurrent abdominal wall defect; (4) Open abdominal cavity, or accompanied by intestinal incarceration and strangulation, bowel resection must be performed at the same time, mesh removal and multiple abdominal wall defects must be performed at the same time. 4. Those who can tolerate general anesthesia surgery after evaluation by the research members; 5. Agree to 3D visualization and 3D printing for preoperative planning; 6. The subjects themselves or their legal representatives agree to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients who have participated in other clinical trials within 3 months before the start of this trial; 2. Pregnant, lactating women and patients planning to become pregnant; 3. Patients undergoing radiotherapy or chemotherapy; 4. Uncontrolled cardiovascular and cerebrovascular diseases, NYHA cardiac function class II or above 5. Patients who are judged by the investigator to have severe endocrine and metabolic diseases, systemic immune diseases, blood and respiratory diseases, and are not suitable to participate in this trial; 6. There are uncontrolled infections throughout the body; 7. Patients with liver disease or liver injury (ALT and AST exceed 2 times the upper limit of normal); 8. Patients with severe renal impairment or renal failure (serum creatinine greater than 2 times the upper limit of normal); 9. Patients who are unable to complete follow-up regularly. 10. Those who are addicted to alcohol, drugs or other drugs; 11. Patients who cannot tolerate enhanced CT examination; 12. Those who are positive in the primary screening test for HIV antibodies.

Design outcomes

Primary

MeasureTime frame
recovery rate;

Secondary

MeasureTime frame
Complication rate;3 d model accuracy;

Countries

China

Contacts

Public ContactGu Yan

Huadong Hospital, Fudan University

guyan_8@hotmail.com+86 13661756660

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026