CAES for Internal Hemorrhoids and Rectal Prolapse

Sponsor

Faming Zhang (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04169152

Collaborator

(none)

10,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Internal Hemorrhoid Rectal Prolapse	Procedure: Cap-assisted endoscopic sclerotherapy

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Dec 30, 2019

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Internal hemorrhoids and rectal prolapse Participants were treated with Cap-assisted endoscopic sclerotherapy (CAES).	Procedure: Cap-assisted endoscopic sclerotherapy 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.

Arm

Intervention/Treatment

Internal hemorrhoids and rectal prolapse

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

Procedure: Cap-assisted endoscopic sclerotherapy

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.

Outcome Measures

Primary Outcome Measures

Recurrence rate [1st week to 24th week]
Recurrence defined as recurrent prolapse, bleeding and other symptoms such as anal pendant expansion, itching, dampness and others after CAES or seeking repeat CAES treatment, alternative non-surgical/surgical treatments for internal hemorrhoids or rectal prolapse (except medication treatment).

Secondary Outcome Measures

Improvement rate [1st day, 1st week, 2nd week and 24th week]
Bleeding, prolapse, and anal pain had resolved or remitted after CAES. Bleeding is divided into three degrees: 1. No bleeding; 2. 2: occasionally; 3: quite often.There are three degrees of prolapse: 1. No prolapse; 2: occasionally; 3: quite often.NRS pain digital rating scale was adopted, that is, 0-10 was used to represent different degrees of pain, 0 was painless, and 10 was severe pain. 0 painless, 1-3 mild pain (pain does not affect sleep), 4-6 moderate pain, 7-9 severe pain (inability to fall asleep or waking up during sleep), 10 severe pain.
Failure rate [1st day, 1st week, 2nd week and 24th week]
Bleeding, prolapse, and anal pain remained the same after CAES. Bleeding is divided into three degrees: 1. No bleeding; 2. 2: occasionally; 3: quite often.There are three degrees of prolapse: 1. No prolapse; 2: occasionally; 3: quite often.NRS pain digital rating scale was adopted, that is, 0-10 was used to represent different degrees of pain, 0 was painless, and 10 was severe pain. 0 painless, 1-3 mild pain (pain does not affect sleep), 4-6 moderate pain, 7-9 severe pain (inability to fall asleep or waking up during sleep), 10 severe pain.
Three-level EuroQol five dimensions (ED-5Q) health scale scores [24th week]
The ED-5Q questionnaire includes five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), with three levels in each dimension (no/moderate/severe problem). Through the Chinese time trade-off (TTO) value table, the health status of five dimensions will be converted into a preference weight of a ED-5Q index score for further analysis.
Adverse events (AEs) [1st day, 1st week, 2nd week and 24th week]
AEs refer to adverse medical events that occurs during or after CAES, including bleeding, anal pain, having difficulties in passing gas and defecation, infection, ulcer/bleeding in the injection points under endoscopic examination (5-7 days after CAES) and other symptoms.
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]
SAEs include serious complications directly or indirectly related to the CAES, such as death, bleeding, perforation, infection.
Participants' attitudes toward CAES [24th week]
The survey on the satisfaction with CAES efficacy, and the willingness to recommend CAES to others.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.