Comparison of the Clinical Efficacy and Safety of Endoscopic Superior Rectal Mucosal Ligation and Hemorrhoids Ligation

Comparison of the Efficacy and Safety of Endoscopic Hemorrhoids Ligation: a Single-center Randomized Controlled Clinical Trial

Endoscopic superior rectal mucosal ligation and hemorrhoids ligation are two types of endoscopic ligation, The aim of this study is to compare the clinical efficacy and safety of these two approaches.If you accept this study,you need to provide case information before the operation, complete the endoscopic treatment according to the routine colonoscopy procedure, and follow-up survey after the operation.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemorrhoids
• Intervention / Treatment: Procedure: Endoscopic superior rectal mucosal ligation; Procedure: Endoscopic hemorrhoid ligation

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Na Zu; Phone Number: 19105496203; Email: 19105496203@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. According to the Goligher classification in the Chinese guidelines for the diagnosis and treatment of hemorrhoids (2020) , patients who are diagnosed with grade II-III internal hemorrhoids .
2. Patients who voluntarily participate and sign the informed consent form.

Exclusion Criteria:

1. patients who had severe heart, liver, and kidney disease.
2. patients who had severe immune deficiency.
3. patient's general condition is too poor to tolerate endoscopic therapy.
4. patients had a history of pelvic chemoradiotherapy.
5. patients had severe infection or inflammatory lesion in the rectum or anal canal,or the rectum or anal canal had undergone surgery.
6. patient is a pregnant woman.
7. patients who disagree with endoscopic treatment and are concerned about the possible risks refused to sign the informed consent form.
8. the follow-up time is insufficient and the clinical data were incomplete.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic superior rectal mucosal ligation group; The patient is treated with endoscopic superior rectal mucosal ligation	Procedure: Endoscopic superior rectal mucosal ligation; The patient takes the left side decubitus position, the endoscope is connected with 6 serial ligators, the cup of the sleeve is pointed at the upper edge of the straight anal line and the rectal mucosa is continuously aspirated under negative pressure. The mucosa enters the sleeve and sees a full-screen red sign. The sensing loop is successfully triggered, indicating that the loop is complete.
Active Comparator: Endoscopic hemorrhoid ligation group; The patient is treated with endoscopic hemorrhoids ligation	Procedure: Endoscopic hemorrhoid ligation; The patient takes the left side decubitus position,the endoscope is connected with 6 serial ligators,the cup the sleeve is aligned with the base of the hemorrhoid (above the dentate line) for continuous negative pressure suction.The hemorrhoid enters the sleeve and sees a full-screen red sign. Turn the handle of the sleeve clockwise and feel that the loop is successfully triggered, the ligature is completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication	Postoperative complications, such as dysuria, thrombotic external hemorrhoids, perianal abscess,and so on.	7 days after operation
clinical efficacy	Complete disappearance of postoperative symptoms is regarded as a cure, postoperative symptoms relief is regarded as partial cure, and symptoms as same as before are considered ineffective.	1 month after operation

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: QYFYEC2024-137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The statistical results of the clinical data collected in the experiment (baseline characteristics, preoperative disease-related data, postoperative disease-relate）will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No