Comparison of the Clinical Efficacy and Safety of Endoscopic Superior Rectal Mucosal Ligation and Hemorrhoids Ligation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic superior rectal mucosal ligation, Endoscopic hemorrhoid ligation.
- Who it may be relevant to
- Registry conditions: Hemorrhoids. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of the Efficacy and Safety of Endoscopic Hemorrhoids Ligation: a Single-center Randomized Controlled Clinical Trial
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- complication [Time frame: 7 days after operation]
- clinical efficacy [Time frame: 1 month after operation]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06649786 · QYFYEC2024-137