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

Официальное название

Comparison of the Efficacy and Safety of Endoscopic Hemorrhoids Ligation: a Single-center Randomized Controlled Clinical Trial

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• complication [Срок оценки: 7 days after operation]
• clinical efficacy [Срок оценки: 1 month after operation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06649786 · QYFYEC2024-137

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗