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Deep learning image evaluation of a concurrent biomesh placement clinical trial to prevent incisional hernia during enterostomy stoma reversal surgery

Deep learning image evaluation of a concurrent biomesh placement clinical trial to prevent incisional hernia during enterostomy stoma reversal surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064995
Enrollment
Unknown
Registered
2022-10-25
Start date
2024-10-01
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

incisional hernia

Interventions

Intervention group:ileostomy closure + biological mesh placement
Control group:ileostomy closure

Sponsors

Shanghai Jiaotong University School of Medicine, Renji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-80 years old with definitive rectal cancer resected requiring prophylactic stoma retraction and assessed by image-based deep learning model as having high risk factors for incisional hernia; 2. Resectable tumor and without distant metastasis (cT1-3N1-2M0) as assessed by CT, MRI and other examinations; 3. Patients who had exclusion criteria but were downstaged by neoadjuvant chemotherapy could be included; 4. Having detailed and complete data of previous surgery and postoperative adjuvant therapy (including but not limited to detailed clinical data such as previous surgery admission record, surgery record, discharge summary, preoperative and postoperative follow-up CT of previous surgery, postoperative radiotherapy time and regimen); 5. Those who voluntarily participate in this study can follow up as required and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Transendoscopic local excision is feasible at stage T1; 2. Previous surgical history of rectal cancer, pregnancy, ASA > III, emergency surgery, and other surgeries at the same time; 3. Combined important organ dysfunction cannot tolerate surgery; 4. Those who cannot accept porcine-derived devices due to religion, ethnicity and other issues; 5. Subjects who are considered by the investigator to be unsuitable for this clinic; 6. Those with combined mental illness or those who cannot cooperate with the corresponding diagnosis and treatment follow-up. ollow-up.

Design outcomes

Primary

MeasureTime frame
Rate of incision hernia after operation;

Secondary

MeasureTime frame
incidence of incisional infection;incidence of incisional local pain;incidence of incisional seroma;

Countries

China

Contacts

Public ContactZizhen Zhang

Shanghai Jiaotong University School of Medicine, Renji Hospital

zzzhang16@hotmail.com+86 139 1787 9569

Outcome results

None listed

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