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

NCT06649786 | Not Yet Recruiting DMC

• 1 other identifier: QYFYEC2024-137
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Endoscopic superior rectal mucosal ligation group

EXPERIMENTAL

The patient is treated with endoscopic superior rectal mucosal ligation

Procedure: Endoscopic superior rectal mucosal ligation

Endoscopic hemorrhoid ligation group

ACTIVE COMPARATOR

The patient is treated with endoscopic hemorrhoids ligation

Procedure: Endoscopic hemorrhoid ligation

Interventions

Endoscopic superior rectal mucosal ligation PROCEDURE

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.

Endoscopic superior rectal mucosal ligation group

Endoscopic hemorrhoid ligation PROCEDURE

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.

Endoscopic hemorrhoid ligation group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .
• Patients who voluntarily participate and sign the informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Na Zu

CONTACT

19105496203; 19105496203@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 21, 2024
• Study Start: November 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share