RecruitingNCT04169152

CAES for Internal Hemorrhoids and Rectal Prolapse

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


Sponsor

Faming Zhang

Enrollment

10,000 participants

Start Date

Dec 30, 2019

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria2

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

Exclusion Criteria12

  • 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.

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Interventions

PROCEDURECap-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.


Locations(1)

Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT04169152


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