Comparison of the Clinical Efficacy and Safety of Endoscopic Superior Rectal Mucosal Ligation and Hemorrhoids Ligation
NCT ID: NCT06649786
Last Updated: 2024-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
96 participants
INTERVENTIONAL
2024-11-01
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Endoscopic superior rectal mucosal ligation group
The patient is treated with endoscopic superior rectal mucosal ligation
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.
Endoscopic hemorrhoid ligation group
The patient is treated with endoscopic hemorrhoids ligation
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Patients who voluntarily participate and sign the informed consent form.
Exclusion Criteria
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.
18 Years
90 Years
ALL
No
Sponsors
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The Affiliated Hospital of Qingdao University
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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QYFYEC2024-137
Identifier Type: -
Identifier Source: org_study_id
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