CAES for Internal Hemorrhoids and Rectal Prolapse
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cap-assisted endoscopic sclerotherapy.
- Who it may be relevant to
- Registry conditions: Internal Hemorrhoid, Rectal Prolapse. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse: a National Multi-centre Prospective Cohort Study
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Recurrence rate [Time frame: 1st week to 24th week]
Secondary outcome measures (7)
- Improvement rate [Time frame: 1st day, 1st week, 2nd week and 24th week]
- Failure rate [Time frame: 1st day, 1st week, 2nd week and 24th week]
- Three-level EuroQol five dimensions (ED-5Q) health scale scores [Time frame: 24th week]
- Adverse events (AEs) [Time frame: 1st day, 1st week, 2nd week and 24th week]
- severe adverse events (SAEs) severe adverse events (SAEs) severe adverse events (SAEs) Severe adverse events (SAEs) [Time frame: 1st day, 1st week, 2nd week and 24th week]
- Participants' attitudes toward CAES [Time frame: 24th week]
- Symptom severity score [Time frame: 1day and 24 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical Unive — Nanjing
Publications
- Zhang T, Xu LJ, Xiang J, He Z, Peng ZY, Huang GM, Ji GZ, Zhang FM. Cap-assisted endoscopic sclerotherapy for hemorrhoids: Methods, feasibility and efficacy. World J Gastrointest Endosc. 2015 Dec 25;7(19):1334-40. doi: 10.4253/wjge.v7.i19.1334. PMID 26722615
- Tomiki Y, Ono S, Aoki J, Takahashi R, Sakamoto K. Endoscopic sclerotherapy with aluminum potassium sulfate and tannic acid for internal hemorrhoids. Endoscopy. 2014;46 Suppl 1 UCTN:E114. doi: 10.1055/s-0034-1364884. Epub 2014 Mar 27. No abstract available. PMID 24676816
- Tokunaga Y. Clinical utility of sclerotherapy with a new agent for treatment of rectal prolapse in patients with risks. J Clin Gastroenterol. 2014 Apr;48(4):356-9. doi: 10.1097/MCG.0b013e318299cab8. PMID 23751842
Identifiers
NCT: NCT04169152 · CAES-CN-191111