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

Polyps Clinical Trial

Official title:

Feasibility of a New Ligation Using the Double-loop Clips Technique Versus Traditional Techniques in the Treatment of Large Wounds After Endoscopic Resection: a Prospective Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05042947
• Other study ID #: DLCT-1.0
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2022
• Source: Ningbo No. 1 Hospital
• Contact: Lei f Xu
• Phone: +8613486659126
• Email: xulei22[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Polyps

Intervention

Device:
• double-loop clips
a new ligation method using the double-loop clips (D-L clips) technique
• Titanium Clip
the Titanium Clip

Locations

Country	Name	City	State
China	Ningbo first hospital	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete closure rate	Main outcome was complete clip closure of the mucosal resection defect. The defect was considered completely closed when there was no remaining visible mucosal defect and clips were <1cm apart.	1 hour
Secondary	Operating time	The time from when the first clip is hit until it is completely closed	1 hour
Secondary	Closing speed	Resection area divided by clamping time	1 hour