Health TrialsbyHealthPanel

CAES for Internal Hemorrhoids and Rectal Prolapse

ConditionsInternal HemorrhoidRectal Prolapse
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFaming Zhang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Patients with bowel preparation.

Disqualifiers

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.

Trial population

Grade I-III internal hemorrhoids and/or rectal prolapse

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cap-assisted endoscopic sclerotherapy

    Procedure/Surgery

    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.

Treatment groups

10,000 Participants
are divided into 1 treatment group
Group A: Internal hemorrhoids and rectal prolapse1 intervention

Trial outcomes

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).

Time frame
1st week to 24th week

Secondary outcomes

1

Improvement rate

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.

Time frame
1st day, 1st week, 2nd week and 24th week
2

Failure rate

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.

Time frame
1st day, 1st week, 2nd week and 24th week
3

Three-level EuroQol five dimensions (ED-5Q) health scale scores

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.

Time frame
24th week
4

Adverse events (AEs)

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.

Time frame
1st day, 1st week, 2nd week and 24th week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Faming Zhang

Lead sponsor

The Second Hospital of Nanjing Medical University

Sponsor institution

Source ClinicalTrials.gov
Apply now