CAES for Internal Hemorrhoids and Rectal Prolapse

NCT04169152 | Recruiting

• 1 other identifier: CAES-CN-191111
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Internal Hemorrhoid; Rectal Prolapse

Keywords

Cap-assisted endoscopic sclerotherapy; Internal Hemorrhoid; Rectal Prolapse

Outcome Measures

Primary Outcomes (1)

• Recurrence rate

  Recurrence rate defined as the proportion of patients with recurrent hemorrhoids at 24 weeks post-CAES, as derived from patients' self-reported answer. Patients will be considered to have recurrent hemorrhoids when any of the following are recorded: (1) "Unchanged or worse compared with before starting treatment" at 24th week as reported by the patient, or (2) seeking repeat CAES treatment, alternative non-surgical/surgical treatments for internal hemorrhoids within 24weeks (except medication treatment), or (3) presence of any symptoms or events that strongly indicated recurrent hemorrhoids among patients not meeting (1) or (2).

  1st week to 24th week

Secondary Outcomes (7)

• 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

Study Arms (1)

Internal hemorrhoids and rectal prolapse

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

Procedure: Cap-assisted endoscopic sclerotherapy

Interventions

Cap-assisted endoscopic sclerotherapy PROCEDURE

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.

Internal hemorrhoids and rectal prolapse

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Grade I-III internal hemorrhoids and/or rectal prolapse

You may qualify if:

• Grade I-III internal hemorrhoids (with or without external hemorrhoids) or/and recal prolapse.
• Patients with bowel preparation.

You may not qualify if:

• History of anoscopic/endoscopic sclerotherapy.
• Acute thrombotic hemorrhoids or grade IV internal hemorrhoids.
• Anal stenosis, perianal and perirectal abscess, anal fissure, fistula, fecal incontinence and other severe complications (such as severe anal pain).
• Inflammatory bowel disease.
• Full-thickness rectal prolapse through the anus.
• Acute diarrhea in the past 24 hours.
• Hypertensive with uncontrolled blood pressure.
• Cerebrovascular accident.
• Blood coagulation dysfunction.
• Pregnant women.
• Mental disorders.
• Decompensated cirrhosis.

Sponsors & Collaborators

• Faming Zhang: lead

Study Sites (1)

Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

RECRUITING

Related Publications (3)

• Zhang T, Xu LJ, Xiang J, He Z, Peng ZY, Huang GM, Ji GZ, Zhang FM. Cap-assisted endoscopic sclerotherapy for hemorrhoids: Methods, feasibility and efficacy. World J Gastrointest Endosc. 2015 Dec 25;7(19):1334-40. doi: 10.4253/wjge.v7.i19.1334.

  PMID: 26722615 BACKGROUND

• Tomiki Y, Ono S, Aoki J, Takahashi R, Sakamoto K. Endoscopic sclerotherapy with aluminum potassium sulfate and tannic acid for internal hemorrhoids. Endoscopy. 2014;46 Suppl 1 UCTN:E114. doi: 10.1055/s-0034-1364884. Epub 2014 Mar 27. No abstract available.

  PMID: 24676816 BACKGROUND

• Tokunaga Y. Clinical utility of sclerotherapy with a new agent for treatment of rectal prolapse in patients with risks. J Clin Gastroenterol. 2014 Apr;48(4):356-9. doi: 10.1097/MCG.0b013e318299cab8.

  PMID: 23751842 BACKGROUND

MeSH Terms

Conditions

Rectal Prolapse

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Faming Zhang, MD,PhD

  The Second Hospital of Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Faming Zhang, MD,PhD

CONTACT

02558509884; fzhang@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 19, 2019
• Study Start: December 30, 2019
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)