Internal HemorrhoidNCT06250140
Recurrence Rate of Minimally Invasive Endoscopic Treatment of Internal Hemorrhoids
An observational study of Internal Hemorrhoid, run by Shenzhen Hospital of Southern Medical University.
Trial summary
2.1 Main objective: To observe the short-term and long-term recurrence rates of various endoscopic minimally invasive treatment methods for internal hemorrhoids and different time points of endoscopic minimally invasive treatment for internal hemorrhoids in patients with grade I-III internal hemorrhoids 2.2 Secondary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Internal Hemorrhoid
- What is being tested?
- Tie up device
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Aug 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with internal hemorrhoids who had undergone endoscopic treatment for internal hemorrhoids could be enrolled in the study after informed consent was obtained
Who may be able to join
- 1. Age ≥18 years old, both sexes
- 2, grade I-III internal hemorrhoids with symptoms related to internal hemorrhoids
- 3. The purpose and adverse consequences of endoscopic minimally invasive treatment of internal hemorrhoids have been fully understood before surgery, and the informed consent for endoscopic minimally invasive treatment of internal hemorrhoids has been signed
Who cannot join
- 1. Patients with contraindications to endoscopic minimally invasive treatment (1) grade IV internal hemorrhoids, mixed hemorrhoids and external hemorrhoids; (2) I-III
- Degree of internal hemorrhoids with incarceration, thrombosis, erosion, infection, etc. (3) patients with severe systemic diseases could not tolerate endoscopic treatment; (4) accompanied by crissum infectious disease, anal fistula, and inflammatory bowel disease activity, etc.; (5) in menstrual period, pregnancy and puerperium, (6) patients with sclerotherapy allergy; (7) function of blood coagulation disorder or are using anticoagulant drugs.
- 2. Patients with a history of allergy to narcotic drugs
- 3. Patients who were deemed by the investigator to be ineligible for participation in the trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter Retrospective Study on the Recurrence Rate of Minimally Invasive Endoscopic Treatment of Internal Hemorrhoids
2.1 Main objective: To observe the short-term and long-term recurrence rates of various endoscopic minimally invasive treatment methods for internal hemorrhoids and different time points of endoscopic minimally invasive treatment for internal hemorrhoids in patients with grade I-III internal hemorrhoids
2.2 Secondary objective: To observe the safety and efficacy of endoscopic minimally invasive treatment of internal hemorrhoids
- Conditions
- Internal Hemorrhoid
- Being tested
- Tie up device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tie up deviceDevice
The recurrence rate of internal hemorrhoids in different treatment methods
| Study group | Role | What they receive |
|---|---|---|
| Internal hemorrhoid ligation group | Endoscopic internal hemorrhoid ligation Receives: Device: Tie up device | |
| Hemorrhoids injection group | Endoscopic hemorrhoid injection was performed Receives: Device: Tie up device | |
| Internal hemorrhoids combined treatment group | Lines of endoscopic hemorrhoids and internal ligation under endoscope to injection Receives: Device: Tie up device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of minimally invasive endoscopic treatment
If patients with internal hemorrhoids recurred with preoperative clinical symptoms (bleeding, prolapse, pain, etc.), which could not be relieved by conservative treatment, and needed endoscopic sclerotherapy, ligation, ligation sclerotherapy or surgery again, the recurrence rate = the number of recurrent cases/the number of patients X100%
Measured: One year
Secondary outcomes (3)
The overall efficacy of various treatment methods
(1) Cure: the symptoms of hematochezia and prolapse disappeared completely. (2) Remarkable effect: the symptoms of hematochezia and prolapse were significantly improved, or the symptoms were alleviated but the frequency and degree of attack were reduced compared with those before operation; (3) Ineffective: the symptoms of hematochezia and prolapse were not relieved or even aggravated. Total effective rate = (cure + marked effective)/total ratio X100%
Measured: One year
Recurrence rates of various treatment modalities in different grades
Measured: One year
The efficacy of sequential treatment after recurrence was evaluated
Patients with internal hemorrhoids who had preoperative clinical symptoms (bleeding, prolapse, pain, etc.) at more than 3 months after operation, and failed to be relieved by conservative treatment, needed endoscopic sclerotherapy, ligation, ligation sclerotherapy or surgery again were regarded as recurrence. Total effective rate = (cure + marked effective)/total ratio X100%
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hospital of Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- 964 hospital of joint Logistics Support Force, The Chinese people's liberation army army medical center
- Responsible party
- Principal investigator, Ying Zhu, Shenzhen Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250140
- Sponsor's protocol ID
- ShenzhenH
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Huang X, Xu W, Lin H, Jiang P, Yang H, Chen L, Yang K, Huang Y, Zhu Y, Liu J. Evaluation of short-term outcomes of Endoscopic Super-Hemorrhoidal Banding for mixed hemorrhoids with prolapsed internal hemorrhoids: a retrospective study. BMC Surg. 2026 Apr 15;26(1):363. doi: 10.1186/s12893-026-03744-z.
PubMed 41987169
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Retrospective Study on the Recurrence Rate of Minimally Invasive Endoscopic Treatment of Internal Hemorrhoids
- ClinicalTrials.gov ID
- NCT06250140
- Acronym / sponsor ID
- ShenzhenH
- Conditions
- Internal Hemorrhoid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Shenzhen Hospital of Southern Medical UniversityUniversity, hospital or other
- Collaborators
- 964 hospital of joint Logistics Support Force, The Chinese people's liberation army army medical center
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 8 Feb 2024 (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.
2.1 Main objective: To observe the short-term and long-term recurrence rates of various endoscopic minimally invasive treatment methods for internal hemorrhoids and different time points of endoscopic minimally invasive treatment for internal hemorrhoids in patients with grade I-III internal hemorrhoids
2.2 Secondary objective: To observe the safety and efficacy of endoscopic minimally invasive treatment of internal hemorrhoids
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internal hemorrhoid ligation group | – | Device: Tie up deviceEndoscopic internal hemorrhoid ligation |
| Hemorrhoids injection group | – | Device: Tie up deviceEndoscopic hemorrhoid injection was performed |
| Internal hemorrhoids combined treatment group | – | Device: Tie up deviceLines of endoscopic hemorrhoids and internal ligation under endoscope to injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with internal hemorrhoids who had undergone endoscopic treatment for internal hemorrhoids could be enrolled in the study after informed consent was obtained
Key inclusion criteria (3 listed)
- 1. Age ≥18 years old, both sexes
- 2, grade I-III internal hemorrhoids with symptoms related to internal hemorrhoids
- 3. The purpose and adverse consequences of endoscopic minimally invasive treatment of internal hemorrhoids have been fully understood before surgery, and the informed consent for endoscopic minimally invasive treatment of internal hemorrhoids has been signed
Key exclusion criteria (4 listed)
- 1. Patients with contraindications to endoscopic minimally invasive treatment (1) grade IV internal hemorrhoids, mixed hemorrhoids and external hemorrhoids; (2) I-III
- Degree of internal hemorrhoids with incarceration, thrombosis, erosion, infection, etc. (3) patients with severe systemic diseases could not tolerate endoscopic treatment; (4) accompanied by crissum infectious disease, anal fistula, and inflammatory bowel disease activity, etc.; (5) in menstrual period, pregnancy and puerperium, (6) patients with sclerotherapy allergy; (7) function of blood coagulation disorder or are using anticoagulant drugs.
- 2. Patients with a history of allergy to narcotic drugs
- 3. Patients who were deemed by the investigator to be ineligible for participation in the trial
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 |
|---|---|---|
| Tie up deviceThe recurrence rate of internal hemorrhoids in different treatment methods | Device | Hemorrhoids injection group, Internal hemorrhoid ligation group, Internal hemorrhoids combined treatment group |
Primary outcome
Recurrence rate of minimally invasive endoscopic treatment
Time frame: One year
If patients with internal hemorrhoids recurred with preoperative clinical symptoms (bleeding, prolapse, pain, etc.), which could not be relieved by conservative treatment, and needed endoscopic sclerotherapy, ligation, ligation sclerotherapy or surgery again, the recurrence rate = the number of recurrent cases/the number of patients X100%
3 secondary outcomes
The overall efficacy of various treatment methods
Time frame: One year
Recurrence rates of various treatment modalities in different grades
Time frame: One year
The efficacy of sequential treatment after recurrence was evaluated
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 41987169Huang X, Xu W, Lin H, Jiang P, Yang H, Chen L, Yang K, Huang Y, Zhu Y, Liu J. Evaluation of short-term outcomes of Endoscopic Super-Hemorrhoidal Banding for mixed hemorrhoids with prolapsed internal hemorrhoids: a retrospective study. BMC Surg. 2026 Apr 15;26(1):363. doi: 10.1186/s12893-026-03744-z.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Internal Hemorrhoid, run by Shenzhen Hospital of Southern Medical University.
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 3 inclusion and 4 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 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Ying Zhu Ying Zhu, Professor (+86 13384662039 ext. Y, zhuying1@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of minimally invasive endoscopic treatment (time frame: One year). 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 NCT06250140, which also lists 1 linked publication.
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 8 Feb 2024.