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.
Study 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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Grade I-III internal hemorrhoids (with or without external hemorrhoids) or/and recal prolapse.
2. Patients with bowel preparation.
Exclusion Criteria:
1. History of anoscopic/endoscopic sclerotherapy.
2. Acute thrombotic hemorrhoids or grade IV internal hemorrhoids.
3. Anal stenosis, perianal and perirectal abscess, anal fissure, fistula, fecal incontinence and other severe complications (such as severe anal pain).
4. Inflammatory bowel disease.
5. Full-thickness rectal prolapse through the anus.
6. Acute diarrhea in the past 24 hours.
7. Hypertensive with uncontrolled blood pressure.
8. Cerebrovascular accident.
9. Blood coagulation dysfunction.
10. Pregnant women.
11. Mental disorders.
12. Decompensated cirrhosis.
Primary outcome measure(s)
Recurrence rate — 1st week to 24th week 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).
Trial sites (1)
Facility
City
Region
Status
Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.