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Clinical validation of a novel scoring model for preoperative assessment of the technical difficulty of endoscopic submucosal dissection for colorectal mucosal lesions: a multicenter prospective study

Clinical validation of a novel scoring model for preoperative assessment of the technical difficulty of endoscopic submucosal dissection for colorectal mucosal lesions: a multicenter prospective study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047087
Enrollment
Unknown
Registered
2021-06-08
Start date
2021-06-08
Completion date
Unknown
Last updated
2022-01-18

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

Conditions

colorectal tumor

Interventions

Case series:no

Sponsors

Zhongshan Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged >=18 years; 2. The lesions were diagnosed as colorectal mucosal lesions >= 2cm before surgery and suitable for ESD, that is, the lesions were determined to be confined to the mucosal layer before surgery or infiltrated to less than 1000um below the mucosa (SM1); 3. Imaging examination showed no distant metastasis; 4. No other colorectal organic diseases; 5. Patients or family members who can understand the study protocol and are willing to participate in the study should provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with simultaneous colorectal organic disease; 2. Pregnant or lactating women; 3. The American Society of Anesthesiologists (ASA) grade is greater than iii, can not tolerate anesthesia and surgery; 4. Patients transferred to surgery.

Design outcomes

Primary

MeasureTime frame
Area under Curve;

Secondary

MeasureTime frame
surgery period;surgery speech;Block cut rate;Intraoperative complication rate;Complete excision rate;The incidence of postoperative complications;days in hospital after surgery;

Countries

China

Contacts

Public ContactZhong Yunshi

Zhongshan Hospital affiliated to Fudan University

zhong.yunshi@zs-hospital.sh.cn+86 13564623481

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026