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

ConditionHemorrhoids
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorThe Affiliated Hospital of Qingdao University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endoscopic superior rectal mucosal ligation

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Endoscopic superior rectal mucosal ligation groupExperimental treatment 1 intervention
Group B: Endoscopic hemorrhoid ligation groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

complication

Postoperative complications, such as dysuria, thrombotic external hemorrhoids, perianal abscess,and so on.

Time frame
7 days after operation
2

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.

Time frame
1 month after operation

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: