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Construction of an innovative multi-disciplinary cooperative clinical diagnosis and treatment system for complex abdominal wall defects

Construction of an innovative multi-disciplinary cooperative clinical diagnosis and treatment system for complex abdominal wall defects

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036180
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-31

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:Innovative multi-disciplinary management of complex abdominal wall defects was carried out, preoperative 3D visualization and printing were performed to assist preoperative planning
Contral group:Routine diagnosis and treatment of complex abdominal wall defects were performed

Sponsors

The Ninth People's Hospital affiliated to Shanghai Jiao Tong University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) The subject or his legal representative signed the informed consent form. 2) 18-75 years old (including 18 and 75 years old), regardless of gender. 3) Patients who meet the "Chinese Expert Consensus on Abdominal Wall Defect Repair and Reconstruction (2019 Edition)" diagnostic criteria for complex abdominal wall defects: a: The size and location of the abdominal wall defect: huge abdominal wall defect (defect width >= 10cm), abdominal wall defect with abdominal wall dysfunction (loss of domain, LOD), and abdominal wall defect where the defect occurs in special parts such as the suprapubic and subcostal margins. b: The condition of the soft tissue of the abdominal wall: with contamination or infection, after extensive resection of the abdominal wall tumor, severe trauma, after multiple operations, after skin grafting, with ulcers or hard-to-heal wounds, and with abdominal wall defects near the stoma or fistula. c: The patient's general condition and history of past diseases: accompanied by various risk factors, such as obesity, diabetes, chronic obstructive pulmonary disease, large amounts of ascites, use of steroid hormones, poor nutritional status, etc., history of incision dehiscence, patching Or the recurrence of abdominal wall defect repaired by tissue structure separation technology. d: Clinical conditions: Open abdominal cavity, or with incarceration or strangulation of intestinal tube, must undergo intestinal resection at the same time, patch removal and multiple abdominal wall defects must be performed at the same time. 4) Agree to plan for 3D visualization and 3D printing.

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) Those with uncontrolled cardiovascular and cerebrovascular diseases and NYHA heart function classification II or above 5) Patients who have been judged by the researcher to have serious endocrine and metabolic diseases, systemic immune diseases, blood, and respiratory diseases, are not suitable for participating in this trial; 6) There are uncontrolled infections throughout the body; 7) Patients with liver disease or liver injury (ALT and AST exceeding 2 times the upper limit of normal); 8) Patients with severe renal impairment or renal failure (serum creatinine is greater than 2 times the upper limit of normal); 9) Patients who cannot complete follow-up regularly. 10) People who are addicted to alcohol, drugs or other drugs have a tendency; 11) Patients who cannot tolerate enhanced CT examination; 12) Those who are positive in the initial HIV antibody screening test.

Design outcomes

Primary

MeasureTime frame
Clinical cure rate of complex abdominal wall defect;

Secondary

MeasureTime frame
Physical examination of postoperative complications;VAS score after surgery;The operation time;Intraoperative blood loss;Postoperative hospitalization days;Preoperative waiting day;Total cost of treatment;

Countries

China

Contacts

Public ContactGu Yan

The Ninth People's Hospital affiliated to Shanghai Jiao Tong University Medical College

yangu@shsmu.edu.cn+86 13661756660

Outcome results

None listed

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