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

NCT ID: NCT05042947

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-12-31

Brief Summary

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.

Conditions

Polyps; Closure; Delay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DLCT

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.

Group Type: EXPERIMENTAL

double-loop clips

Intervention Type: DEVICE

a new ligation method using the double-loop clips (D-L clips) technique

Traditional technology

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

Group Type: ACTIVE_COMPARATOR

Titanium Clip

Intervention Type: DEVICE

the Titanium Clip

Interventions

double-loop clips

a new ligation method using the double-loop clips (D-L clips) technique

Intervention Type: DEVICE

Titanium Clip

the Titanium Clip

Intervention Type: DEVICE

Other Intervention Names

Traditional technology

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo No. 1 Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ningbo first hospital

Ningbo, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lei f Xu

Role: CONTACT

xulei22@163.com

+8613486659126

Facility Contacts

Lei Xu, MD

Role: primary

xulei22@163.com

+86-13486659126

Other Identifiers

DLCT-1.0

Identifier Type: -

Identifier Source: org_study_id