An interventional study of Cap-assisted endoscopic sclerotherapy using long needle and Cap-assisted endoscopic sclerotherapy using short needle in Internal Hemorrhoid and Rectal Prolapse, sponsored by The Second Hospital of Nanjing Medical University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by The Second Hospital of Nanjing Medical University · Not applicable, Interventional, and Treatment
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).
Traditional endoscopic sclerotherapy for internal hemorrhoids require retroflection of the endoscope. Retroflection of the endoscope has blind areas and affects the precise operation. And, short-needle injection can easily lead to artificial ulcer and secondary bleeding. CAES is a new, minimally invasive endoscopic technique for the treatment of internal hemorrhoids and rectal prolapse. CAES was performed based on the requirement of the cap, endoscope, disposable endoscopic long injection needle, enough insufflated air and sclerosing agent. It can accurately control the injection angle, direction and depth under direct vision, and avoid iatrogenic injury caused by ectopic injection to the greatest possible extent. To investigate the effect of long needle and short needle on the outcome of CAES, participants with internal hemorrhoids and rectal prolapse were randomly assigned to a long needle group and a short needle group using a prospective, randomized, controlled study at multiple centers in China. The efficacy, adverse events and satisfaction of the two groups were observed.
55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 55 across 34 interventional studies indexed under Rectal Prolapse.
Browse Rectal Prolapse studies →The Second Hospital of Nanjing Medical University is the lead sponsor of 70 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
Participants were treated with CAES using long needle.
Procedure: Cap-assisted endoscopic sclerotherapy using long needle
Participants were treated with CAES using short needle.
Procedure: Cap-assisted endoscopic sclerotherapy using short needle
Participants were treated with CAES using long needle.
Participants were treated with CAES using short needle.
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: 24 weeks
Symptoms of anal bleeding
Bleeding is divided into three degrees: 1. No bleeding; 2. 2: occasionally; 3: quite often.
Time frame: 1day, 7days, 14days and 24 weeks
Symptoms of prolapse
There are three degrees of prolapse: 1. No prolapse; 2: occasionally; 3: quite often.
Time frame: 1day, 7days, 14days and 24 weeks
Symptoms of anal pain
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: 1day, 7days, 14days and 24 weeks
EQ-5D health scale scores
Before CAES and after CAES, EQ-5D health scale scores were performed.
Time frame: 24 weeks
Adverse events and serious adverse events
Adverse events included bleeding, anal pain, and dyspnea.Serious adverse events include serious complications directly or indirectly related to the operation, such as death, bleeding, perforation, etc.
Time frame: 1day, 7days, 14days and 24 weeks
Satisfaction degree
Number of satisfied participants
Time frame: 24 weeks
Symptom severity score
five questions about hemorrhoidal symptoms (anal pain, prolapse, itching, soiling, and blood loss) will be self-assessed by patients by answering how often each symptom was encountered (never, sometimes, weekly, or daily). The score is the sum of the points from all five questions, ranging from 0 to 15 points, where an increase in number is an increase in symptom.
Time frame: 1day and 24 weeks
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The Second Hospital of Nanjing Medical University