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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06649786
Enrollment
96
Registered
2024-10-21
Start date
2024-11-01
Completion date
2026-04-30
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhoids

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.

Interventions

PROCEDUREEndoscopic 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.

PROCEDUREEndoscopic 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.

Sponsors

The Affiliated Hospital of Qingdao University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
complication7 days after operationPostoperative complications, such as dysuria, thrombotic external hemorrhoids, perianal abscess,and so on.
clinical efficacy1 month after operationComplete 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.

Contacts

Primary ContactNa Zu
19105496203@163.com19105496203

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026