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NCT Number: NCT04169152

CAES for Internal Hemorrhoids and Rectal Prolapse

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Nanjing, Jiangsu, 210011, China

Location status: Recruiting

Location contact

Faming Zhang, MD, PhD

CONTACT

[email protected]

+86-025-58509883

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cap-assisted endoscopic sclerotherapy

Procedure

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 outcomes

  1. Recurrence rate

    Time frame: 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).

Secondary outcomes

  1. Improvement rate

    Time frame: 1st day, 1st week, 2nd week and 24th week

    Bleeding, prolapse, and anal pain had resolved or remitted after CAES. Bleeding is divided into three degrees: 1. No bleeding; 2. 2: occasionally; 3: quite often.There are three degrees of prolapse: 1. No prolapse; 2: occasionally; 3: quite often.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.

  2. Failure rate

    Time frame: 1st day, 1st week, 2nd week and 24th week

    Bleeding, prolapse, and anal pain remained the same after CAES. Bleeding is divided into three degrees: 1. No bleeding; 2. 2: occasionally; 3: quite often.There are three degrees of prolapse: 1. No prolapse; 2: occasionally; 3: quite often.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.

  3. Three-level EuroQol five dimensions (ED-5Q) health scale scores

    Time frame: 24th week

    The ED-5Q questionnaire includes five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), with three levels in each dimension (no/moderate/severe problem). Through the Chinese time trade-off (TTO) value table, the health status of five dimensions will be converted into a preference weight of a ED-5Q index score for further analysis.

  4. Adverse events (AEs)

    Time frame: 1st day, 1st week, 2nd week and 24th week

    AEs refer to adverse medical events that occurs during or after CAES, including bleeding, anal pain, having difficulties in passing gas and defecation, infection, ulcer/bleeding in the injection points under endoscopic examination (5-7 days after CAES) and other symptoms.

  5. 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

    SAEs include serious complications directly or indirectly related to the CAES, such as death, bleeding, perforation, infection.

  6. Participants' attitudes toward CAES

    Time frame: 24th week

    The survey on the satisfaction with CAES efficacy, and the willingness to recommend CAES to others.

  7. Symptom severity score

    Time frame: 1day and 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Faming Zhang, MD,PhD

CONTACT

[email protected]

02558509884

Sponsors and collaborators

Lead sponsor

Faming Zhang

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Nov 19, 2019
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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