Internal HemorrhoidNCT03917056
Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse
A study testing Cap-assisted endoscopic sclerotherapy using long needle and Cap-assisted endoscopic sclerotherapy using short needle in people with Internal Hemorrhoid and Rectal Prolapse, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial summary
This clinical trial aims to evaluate the efficacy and safety of long needle and short needle in the treatment of internal hemorrhoids and rectal prolapse through CAES (Cap-assisted endoscopic sclerotherapy). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Internal Hemorrhoid, Rectal Prolapse
- What is being tested?
- Cap-assisted endoscopic sclerotherapy using long needle and Cap-assisted endoscopic sclerotherapy using short needle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2019to 27 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with internal hemorrhoids and rectal prolapse, combined with external hemorrhoids or without external hemorrhoids.
- Patients with bowel preparation.
Who cannot join
- History of anoscopic/endoscopic sclerotherapy.
- Patients with acute thrombotic external hemorrhoids.
- Patients with serious internal hemorrhoids of grade IV.
- Patients with anal stenosis, anal fissure, fistula, fecal incontinence, ulcerative colitis, Crohn's disease.
- Patients with acute diarrhea in the past 24 hours.
- Hypertensive patients with uncontrolled blood pressure, patients with cerebrovascular accident and obvious bleeding tendency, pregnant women, mental disorders and decompensated cirrhosis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fmt-Dt-N-27/1350
Nanjing, Jiangsu, 210011
Faming Zhang, PhD,MD
Faming Zhang, MD,PhD
About this study
Official title: Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse: a Nationwide Multicenter Randomized Controlled Trial
This clinical trial aims to evaluate the efficacy and safety of long needle and short needle in the treatment of internal hemorrhoids and rectal prolapse through CAES (Cap-assisted endoscopic sclerotherapy).
Read the detailed description
Traditional endoscopic sclerotherapy for internal hemorrhoids require retroflection of the endoscope. Retroflection of the endoscope has blind areas and affects the precise operation. And, short-needle injection can easily lead to artificial ulcer and secondary bleeding. CAES is a new, minimally invasive endoscopic technique for the treatment of internal hemorrhoids and rectal prolapse. CAES was performed based on the requirement of the cap, endoscope, disposable endoscopic long injection needle, enough insufflated air and sclerosing agent. It can accurately control the injection angle, direction and depth under direct vision, and avoid iatrogenic injury caused by ectopic injection to the greatest possible extent. To investigate the effect of long needle and short needle on the outcome of CAES, participants with internal hemorrhoids and rectal prolapse were randomly assigned to a long needle group and a short needle group using a prospective, randomized, controlled study at multiple centers in China. The efficacy, adverse events and satisfaction of the two groups were observed.
- Conditions
- Internal Hemorrhoid, Rectal Prolapse
- Being tested
- Cap-assisted endoscopic sclerotherapy using long needle, Cap-assisted endoscopic sclerotherapy using short needle
- Keywords
- Cap-assisted endoscopic sclerotherapy, Internal Hemorrhoid, Rectal Prolapse
- Medical subject headings
- Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cap-assisted endoscopic sclerotherapy using long needleProcedure or surgery
Participants were treated with CAES using long needle.
Cap-assisted endoscopic sclerotherapy using short needleProcedure or surgery
Participants were treated with CAES using short needle.
| Study group | Role | What they receive |
|---|---|---|
| Long needle group | Experimental | Participants were treated with CAES using long needle. Receives: Procedure: Cap-assisted endoscopic sclerotherapy using long needle |
| Short needle group | Experimental | Participants were treated with CAES using short needle. Receives: Procedure: Cap-assisted endoscopic sclerotherapy using short needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
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).
Measured: 24 weeks
Secondary outcomes (7)
Symptoms of anal bleeding
Bleeding is divided into three degrees: 1. No bleeding; 2. 2: occasionally; 3: quite often.
Measured: 1day, 7days, 14days and 24 weeks
Symptoms of prolapse
There are three degrees of prolapse: 1. No prolapse; 2: occasionally; 3: quite often.
Measured: 1day, 7days, 14days and 24 weeks
Symptoms of anal pain
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.
Measured: 1day, 7days, 14days and 24 weeks
EQ-5D health scale scores
Before CAES and after CAES, EQ-5D health scale scores were performed.
Measured: 24 weeks
Adverse events and serious adverse events
Adverse events included bleeding, anal pain, and dyspnea.Serious adverse events include serious complications directly or indirectly related to the operation, such as death, bleeding, perforation, etc.
Measured: 1day, 7days, 14days and 24 weeks
Satisfaction degree
Number of satisfied participants
Measured: 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.
Measured: 1day and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start24 Jun 2019
- Primary completion1 Mar 2025 (estimated)
- Study completion27 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Internal HemorrhoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
- Investigators
- Faming Zhang, MD,PhD, Principal investigator, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917056
- Sponsor's protocol ID
- CAES-CN-190318
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2019
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 26722615Tomiki 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.
PubMed 24676816Wu X, Wen Q, Cui B, Liu Y, Zhong M, Yuan Y, Wu L, Zhang X, Hu Y, Lv M, Wu Q, He S, Jin Y, Tian S, Wan R, Wang X, Xu L, Bai J, Huang G, Ji G, Zhang F. Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial. Ther Adv Gastrointest Endosc. 2020 Jun 5;13:2631774520925636. doi: 10.1177/2631774520925636. eCollection 2020 Jan-Dec.
PubMed 32551439
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse: a Nationwide Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03917056
- Acronym / sponsor ID
- CAES-CN-190318
- Conditions
- Internal Hemorrhoid, Rectal Prolapse
- Keywords
- Cap-assisted endoscopic sclerotherapy, Internal Hemorrhoid, Rectal Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 27 Mar 2025 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to evaluate the efficacy and safety of long needle and short needle in the treatment of internal hemorrhoids and rectal prolapse through CAES (Cap-assisted endoscopic sclerotherapy).
Detailed description
Traditional endoscopic sclerotherapy for internal hemorrhoids require retroflection of the endoscope. Retroflection of the endoscope has blind areas and affects the precise operation. And, short-needle injection can easily lead to artificial ulcer and secondary bleeding. CAES is a new, minimally invasive endoscopic technique for the treatment of internal hemorrhoids and rectal prolapse. CAES was performed based on the requirement of the cap, endoscope, disposable endoscopic long injection needle, enough insufflated air and sclerosing agent. It can accurately control the injection angle, direction and depth under direct vision, and avoid iatrogenic injury caused by ectopic injection to the greatest possible extent. To investigate the effect of long needle and short needle on the outcome of CAES, participants with internal hemorrhoids and rectal prolapse were randomly assigned to a long needle group and a short needle group using a prospective, randomized, controlled study at multiple centers in China. The efficacy, adverse events and satisfaction of the two groups were observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long needle group | Experimental | Procedure: Cap-assisted endoscopic sclerotherapy using long needleParticipants were treated with CAES using long needle. |
| Short needle group | Experimental | Procedure: Cap-assisted endoscopic sclerotherapy using short needleParticipants were treated with CAES using short needle. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with internal hemorrhoids and rectal prolapse, combined with external hemorrhoids or without external hemorrhoids.
- Patients with bowel preparation.
Key exclusion criteria (6 listed)
- History of anoscopic/endoscopic sclerotherapy.
- Patients with acute thrombotic external hemorrhoids.
- Patients with serious internal hemorrhoids of grade IV.
- Patients with anal stenosis, anal fissure, fistula, fecal incontinence, ulcerative colitis, Crohn's disease.
- Patients with acute diarrhea in the past 24 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cap-assisted endoscopic sclerotherapy using long needleParticipants were treated with CAES using long needle. | Procedure or surgery | Long needle group |
| Cap-assisted endoscopic sclerotherapy using short needleParticipants were treated with CAES using short needle. | Procedure or surgery | Short needle group |
Primary outcome
Recurrence rate
Time frame: 24 weeks
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).
7 secondary outcomes
Symptoms of anal bleeding
Time frame: 1day, 7days, 14days and 24 weeks
Symptoms of prolapse
Time frame: 1day, 7days, 14days and 24 weeks
Symptoms of anal pain
Time frame: 1day, 7days, 14days and 24 weeks
EQ-5D health scale scores
Time frame: 24 weeks
Adverse events and serious adverse events
Time frame: 1day, 7days, 14days and 24 weeks
Satisfaction degree
Time frame: 24 weeks
Symptom severity score
Time frame: 1day and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 26722615Zhang 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.
- Background: PubMed 24676816Tomiki 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.
- Derived from this study: PubMed 32551439Wu X, Wen Q, Cui B, Liu Y, Zhong M, Yuan Y, Wu L, Zhang X, Hu Y, Lv M, Wu Q, He S, Jin Y, Tian S, Wan R, Wang X, Xu L, Bai J, Huang G, Ji G, Zhang F. Cap-assisted endoscopic sclerotherapy for internal hemorrhoids: technique protocol and study design for a multi-center randomized controlled trial. Ther Adv Gastrointest Endosc. 2020 Jun 5;13:2631774520925636. doi: 10.1177/2631774520925636. eCollection 2020 Jan-Dec.
Related trials for Internal Hemorrhoid
Not yet recruiting
Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome
Internal Haemorrhoids
Not yet recruitingPhase 4
Evaluation of Polidocanol Foam Sclerotherapy in Symptomatic Internal Hemorrhoids: A Prospective Study
Internal Piles Sclerotherapy, Internal Hemorrhoids
Not yet recruitingPhase 2
Comparing Rectal Artery Embolization and Surgery for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
Hemorrhoids Internal, Hemorrhoids Second Degree
Recruiting
HELO Trial: Energy-Based Therapies vs. Conventional Hemorrhoidectomy for Grade III Hemorrhoids
Hemorrhoids Third Degree, Internal Hemorrhoids
Recruiting
Rectal Arterial Embolization vs Band Ligation for the Treatment of Internal hemOrrhoidS
Hemorrhoidal Bleeding, Hemorrhoids, Internal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faming Zhang, MD,PhD principal investigator
The Second Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cap-assisted endoscopic sclerotherapy using long needle and Cap-assisted endoscopic sclerotherapy using short needle in people with Internal Hemorrhoid and Rectal Prolapse, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faming Zhang, MD,PhD (86-25-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03917056, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.