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Effect of a novel compound microporous polyglycan styptic powder on preventing bleeding after rectal ESD operation: a multicenter, prospective, randomized, parallel controlled clinical trial

Effect of a novel compound microporous polyglycan styptic powder on preventing bleeding after rectal ESD operation: a multicenter, prospective, randomized, parallel controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100842
Enrollment
Unknown
Registered
2025-04-16
Start date
2024-04-30
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Postoperative rectal ESD

Interventions

Experimental group:The rectal ESD wound was sprayed with a new type of compound microporous polychitosan styptic powder
Control group:The wound after rectal ESD operation was not sprayed with a new type of compound microporous polychitosan styptic powder

Sponsors

Department of Endoscopy, Northern Theater General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age >=18 years old, gender is not limited; (2) Endoscopic diagnosis of rectal lesions, according to the "Chinese Consensus on Endoscopic Diagnosis and Treatment of Colorectal Cancer and precancerous Lesions (Guangzhou, 2023)" and "Expert Consensus on Endoscopic Submucosal Dissection of Digestive Tract Mucosal Lesions", patients with ESD adaptation signs: lesions with long diameter >20 mm and difficult to complete one-time resection using EMR; EMR residue >10 mm or recurrence after treatment for difficult EMR treatment; Submucosal tumor without lymph node metastasis; (3) Voluntarily participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Women during menstruation, pregnancy and lactation; (2) Previous history of colorectal surgery; (3) Patients with serious organic diseases such as cardiovascular and cerebrovascular, lung, liver and kidney; (4) Patients with blood diseases and coagulation disorders; (5) Patients with inflammatory bowel disease and adenomatosis; (6) Patients with history of taking anticoagulant drugs within 1 week before surgery; (7) Register for another clinical trial within four weeks.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative bleeding;

Secondary

MeasureTime frame
Incidence of other complications;

Countries

China

Contacts

Public ContactZhuo Yang

Chinese People's Liberation Army Northern Theater Command General Hospital

yangzhuocy@163.com+86 133 0988 8172

Outcome results

None listed

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