Clinical trial NCT04169152: CAES for Internal Hemorrhoids and Rectal Prolapse
Official title: Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse: a National Multi-centre Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Internal Hemorrhoid
Rectal Prolapse
Keywords: Cap-assisted endoscopic sclerotherapy
Internal Hemorrhoid
Rectal Prolapse
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Grade I-III internal hemorrhoids and/or rectal prolapse

Brief 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.

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.

Eligibility criteria: 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 outcomes:
measure: Recurrence rate
timeFrame: 1st week to 24th week
Secondary outcomes:
measure: Improvement rate
timeFrame: 1st day, 1st week, 2nd week and 24th week
measure: Failure rate
timeFrame: 1st day, 1st week, 2nd week and 24th week
measure: Three-level EuroQol five dimensions (ED-5Q) health scale scores
timeFrame: 24th week
measure: Adverse events (AEs)
timeFrame: 1st day, 1st week, 2nd week and 24th week
measure: severe adverse events (SAEs) severe adverse events (SAEs) severe adverse events (SAEs) Severe adverse events (SAEs)
timeFrame: 1st day, 1st week, 2nd week and 24th week
measure: Participants' attitudes toward CAES
timeFrame: 24th week
measure: Symptom severity score
timeFrame: 1day and 24 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Medical Center for Digestive Diseases, Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The Second Hospital of Nanjing Medical University
name: Faming Zhang, MD,PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.