A New Ligation Using the Double-loop Clips Technique Versus Traditional Techniques in the Treatment of Large Wounds After Endoscopic Resection

Ningbo No. 1 Hospital

Status: Unknown

Conditions: Polyps; Closure; Delay

Treatments: Device: double-loop clips; Device: Titanium Clip

Study type: Interventional

Funder types: Other

Identifiers

NCT05042947

DLCT-1.0

Details and patient eligibility

About

Studies have shown that postoperative inflammation can be relieved by clipping the wound, and can reduce the bleeding rate and perforation rate.Scholars at home and abroad have proposed the use of adhesives and circular surgical lines to clamp the wound.In 2019, Satoshi Abiko and others proposed the use of double-loop clips technology to clamp the wound, and make double-loop clips of appropriate length outside the body.Therefore, our study is a prospective randomized controlled study to explore whether the double-loop clips technique is safe and effective for larger wounds in daily clinical work.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with wounds larger than 20mm
• Patients aged 18 to 75 years old

Exclusion criteria

• Have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or New York heart association class iii-iv.
• Pregnant or breastfeeding.
• Allergy or intolerance to any study drug.
• Patients who have taken anticoagulant drugs (aspirin, clopidogrel, etc.) in the past week but are contraindicated for endoscopic polyp treatment.
• Other imaging findings suggest patients with advanced cancer.
• Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis, and toxic megacolon

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

DLCT

Experimental group

Description:

After finding polyps that meet the inclusion criteria, the surgical method for resection was selected according to the operator's preferences, and the experimental group used double-loop coil clamp technology to treat the wound.

Treatment:

Device: double-loop clips

Traditional technology

Active Comparator group

Description:

After finding polyps that meet the inclusion criteria, the surgical method for resection was selected according to the operator's preferences.The control group used the traditional hemostatic clip technique to treat the wound

Treatment:

Device: Titanium Clip