Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse

NCT03917056 | Recruiting

• 1 other identifier: CAES-CN-190318
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the efficacy and safety of long needle and short needle in the treatment of internal hemorrhoids and rectal prolapse through CAES (Cap-assisted endoscopic sclerotherapy).

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).

  24 weeks

Secondary Outcomes (7)

• Symptoms of anal bleeding

  1day, 7days, 14days and 24 weeks

• Symptoms of prolapse

  1day, 7days, 14days and 24 weeks

• Symptoms of anal pain

  1day, 7days, 14days and 24 weeks

• EQ-5D health scale scores

  24 weeks

• Adverse events and serious adverse events

  1day, 7days, 14days and 24 weeks

Study Arms (2)

Long needle group

EXPERIMENTAL

Participants were treated with CAES using long needle.

Procedure: Cap-assisted endoscopic sclerotherapy using long needle

Short needle group

EXPERIMENTAL

Participants were treated with CAES using short needle.

Procedure: Cap-assisted endoscopic sclerotherapy using short needle

Interventions

Cap-assisted endoscopic sclerotherapy using long needle PROCEDURE

Participants were treated with CAES using long needle.

Long needle group

Cap-assisted endoscopic sclerotherapy using short needle PROCEDURE

Participants were treated with CAES using short needle.

Short needle group

Eligibility Criteria

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

You may qualify if:

• Patients with internal hemorrhoids and rectal prolapse, combined with external hemorrhoids or without external hemorrhoids.
• Patients with bowel preparation.

You may not qualify if:

• History of anoscopic/endoscopic sclerotherapy.
• Patients with acute thrombotic external hemorrhoids.
• Patients with serious internal hemorrhoids of grade IV.
• Patients with anal stenosis, anal fissure, fistula, fecal incontinence, ulcerative colitis, Crohn's disease.
• Patients with acute diarrhea in the past 24 hours.
• Hypertensive patients with uncontrolled blood pressure, patients with cerebrovascular accident and obvious bleeding tendency, pregnant women, mental disorders and decompensated cirrhosis.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

Fmt-Dt-N-27/1350

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

• Wu X, Wen Q, Cui B, Liu Y, Zhong M, Yuan Y, Wu L, Zhang X, Hu Y, Lv M, Wu Q, He S, Jin Y, Tian S, Wan R, Wang X, Xu L, Bai J, Huang G, Ji G, Zhang F. Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial. Ther Adv Gastrointest Endosc. 2020 Jun 5;13:2631774520925636. doi: 10.1177/2631774520925636. eCollection 2020 Jan-Dec.

  PMID: 32551439 DERIVED

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, MD,PhD

CONTACT

86-25-58509883; fzhang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: June 24, 2019
• Primary Completion: March 1, 2025
• Study Completion: March 27, 2025
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

CN (1)