CAES for Internal Hemorrhoids and Rectal Prolapse

Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse: a National Multi-centre Prospective Cohort Study

Patrocinadores

Patrocinador principal: Faming Zhang

Fuente The Second Hospital of Nanjing Medical University
Resumen breve

Cap-assisted endoscopic sclerotherapy (CAES) is a new interventional therapy for internal hemorrhoids and rectal prolapse under colonoscopy. However, the long-term efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse are still not clear due to the lack of large sample studies. Therefore, a nationwide multi-center, large sample, prospective and cohort study was designed to evaluate the efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse, to provide reliable evidence for popularization of this minimally invasive technology.

Descripción detallada

CAES is an innovative endoscopic sclerotherapy procedure which is different from traditional method. Firstly, the cap added to the front of colonoscope can fully expose the operating field. Secondly, before or during the opportunity of CAES, endoscopist can perform endoscopic differentiation diagnosis (such as tumors, inflammatory bowel disease and others induced hematochezia), endoscopic therapy within lower-gut based on the same colon preparation, thus saving patients' medical cost, physical and mental pain. The last but not least, specially designed length of endoscopic injection needle (eg.10-20 mm) was used in CAES could be helpful for accurately controlling the injection angle, direction, depth under direct vision and to avoid iatrogenic injury due to ectopic injection.The core value of CAES for internal hemorrhoids and rectal prolapse is to provide precise therapy, reduce the iatrogenic injuries, avoid pain during and after therapy. Our pilot studies demonstrated that CAES based on long injection needle is an effective, safe, convenient operation technique. 100% of participants underwent CAES showed sustained clinical efficacy within the 3-month follow-up, with no severe or obvious complications related to CAES. However, the long-term efficacy and safety of CAES in the treatment of internal hemorrhoids and rectal prolapse need to be confirmed by further large sample real world studies.

Estado general Not yet recruiting
Fecha de inicio December 30, 2019
Fecha de Terminación June 30, 2023
Fecha de finalización primaria December 30, 2022
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Recurrence rate 1st week to 24th week
Resultado secundario
Medida Periodo de tiempo
Improvement rate 1st day, 1st week, 2nd week and 24th week
Failure rate 1st day, 1st week, 2nd week and 24th week
Three-level EuroQol five dimensions (ED-5Q) health scale scores 24th week
Adverse events (AEs) 1st day, 1st week, 2nd week and 24th week
severe adverse events (SAEs) severe adverse events (SAEs) severe adverse events (SAEs) Severe adverse events (SAEs) 1st day, 1st week, 2nd week and 24th week
Participants' attitudes toward CAES 24th week
Inscripción 10000
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: Cap-assisted endoscopic sclerotherapy

Descripción: Cap-assisted endoscopic sclerotherapy (CAES) is an innovation technique for having advantages in accurately controlling the injection angle, direction, depth under direct vision of flexible endoscope.

Etiqueta de grupo de brazo: Internal hemorrhoids and rectal prolapse

Elegibilidad

Método de muestreo: Probability Sample

Criterios:

Inclusion Criteria:

1. Grade I-III internal hemorrhoids (with or without external hemorrhoids) or/and recal prolapse.

2. Patients with bowel preparation.

Exclusion Criteria:

1. History of anoscopic/endoscopic sclerotherapy.

2. Acute thrombotic hemorrhoids or grade IV internal hemorrhoids.

3. Anal stenosis, perianal and perirectal abscess, anal fissure, fistula, fecal incontinence and other severe complications (such as severe anal pain).

4. Inflammatory bowel disease.

5. Full-thickness rectal prolapse through the anus.

6. Acute diarrhea in the past 24 hours.

7. Hypertensive with uncontrolled blood pressure.

8. Cerebrovascular accident.

9. Blood coagulation dysfunction.

10. Pregnant women.

11. Mental disorders.

12. Decompensated cirrhosis.

Género: All

Edad mínima: N/A

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Faming Zhang, MD,PhD Study Chair The Second Hospital of Nanjing Medical University
Contacto general

Apellido: Faming Zhang, MD,PhD

Teléfono: 02558509884

Email: [email protected]

Fecha de verificación

December 2019

Fiesta responsable

Tipo: Sponsor-Investigator

Afiliación del investigador: The Second Hospital of Nanjing Medical University

Nombre completo del investigador: Faming Zhang

Título del investigador: Professor, Gastroenterology

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: Internal hemorrhoids and rectal prolapse

Descripción: Participants were treated with Cap-assisted endoscopic sclerotherapy (CAES).

Datos del paciente No
Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov