HemorrhoidsNCT07183332
Comparison of Clinical Effects Between Routine and High-frequency Follow-up After Hemorrhoids Surgery
A study testing High frequency follow-up in people with Hemorrhoids, run by The Affiliated Hospital of Putian University at 1 site in China.
Trial summary
This study aims to investigate whether frequent follow-ups can enhance the quality of life of patients after hemorrhoid surgery and reduce the incidence of complications. A total of 116 eligible patients were randomly and evenly divided into two groups (58 patients in each group): A. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- High frequency follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old < age < 75 years old;
- Mixed hemorrhoids were diagnosed;
- Internal hemorrhoids ligation + external hemorrhoidectomy
- Complete hospital records;⑤voluntary cooperation in the study
Who cannot join
- The patient had mental illness;
- Serious underlying diseases;
- pregnant or lactating women;
- Serious complications and drug allergy occurred during the treatment;
- Communication difficulties
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Clinical Effects Between Routine and High-frequency Follow-up After Hemorrhoids Surgery: a Single-center, Prospective, Open-label, Randomized Clinical Trial
This study aims to investigate whether frequent follow-ups can enhance the quality of life of patients after hemorrhoid surgery and reduce the incidence of complications. A total of 116 eligible patients were randomly and evenly divided into two groups (58 patients in each group): A. The control group: Patients received routine health education services upon discharge and were then followed up by phone at the regular frequency. B. The high-frequency group: Patients received routine health education services upon discharge and were then followed up by phone at a higher frequency. The quality of life of the patients and the incidence of complications were compared to evaluate the clinical effects of different intervention measures. The main hypothesis is that compared to conventional care, frequent follow-ups can significantly improve the quality of life of patients, promote wound healing, and reduce the incidence of complications and disease recurrence.
- Conditions
- Hemorrhoids
- Being tested
- High frequency follow-up
- Keywords
- Hemorrhoids, Follow-up, Quality of Life
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency follow-upBehavioural
Patients in the high-frequency group received regular follow-ups at a high frequency after discharge.
| Study group | Role | What they receive |
|---|---|---|
| Conventional group | No intervention | Patients received routine health education services at discharge and were enrolled in the sample data collection cluster. Patients were followed up by telephone by trained medical and nursing teams at 1 week and 1 month after discharge, and then every 3 months until the end of the one-year follow-up period |
| High frequency group | Experimental | Patients received routine health education services at discharge and were enrolled in the sample data collection cluster. Patients were followed up by telephone by a trained medical team at 1, 2, 3, and 4 weeks after discharge, and then every month until the end of the one-year follow-up period. Receives: Behavioral: High frequency follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality-of-life SCORES
By evaluating the quality of life of patients, we proved the effectiveness of different frequency of follow-up methods in improving the quality of life of patients after hemorrhoids surgery.
Measured: Baseline, weeks 2, 4, 12, 24, 48
Secondary outcomes (3)
pain score
The assessment is conducted using the Numerical Rating Scale for Pain (NRS), which requires patients to select an integer (whole number) from 0 to 10 that best describes their pain. 0 typically indicates "no pain", while 10 represents "the most severe pain imaginable".
Measured: Baseline, Day 7, 14, 21, 28
Complication incidence
Record the recurrence of hemorrhoids and the occurrence of complications in the patients in the medium and long term. The complications mainly include: incision infection, wound bleeding, and urinary retention.
Measured: Within six months after discharge
patient satisfaction
The Patient Satisfaction Questionnaire Short Form (PSQ-18) was used for measurement during the telephone follow-up period.
Measured: Baseline, weeks 2, 4, 12, 24, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion14 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Putian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183332
- Sponsor's protocol ID
- PutianU-009
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Based on a strict commitment to participant privacy protection, compliance with the terms of the ethical review protocol, and adherence to the sponsoring institution's policies, IPD from this study will not be shared at this time.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Effects Between Routine and High-frequency Follow-up After Hemorrhoids Surgery: a Single-center, Prospective, Open-label, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07183332
- Acronym / sponsor ID
- PutianU-009
- Conditions
- Hemorrhoids
- Keywords
- Hemorrhoids, Follow-up, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Putian UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 14 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 Sep 2025 (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 study aims to investigate whether frequent follow-ups can enhance the quality of life of patients after hemorrhoid surgery and reduce the incidence of complications. A total of 116 eligible patients were randomly and evenly divided into two groups (58 patients in each group): A. The control group: Patients received routine health education services upon discharge and were then followed up by phone at the regular frequency. B. The high-frequency group: Patients received routine health education services upon discharge and were then followed up by phone at a higher frequency. The quality of life of the patients and the incidence of complications were compared to evaluate the clinical effects of different intervention measures. The main hypothesis is that compared to conventional care, frequent follow-ups can significantly improve the quality of life of patients, promote wound healing, and reduce the incidence of complications and disease recurrence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group | No intervention | –Patients received routine health education services at discharge and were enrolled in the sample data collection cluster. Patients were followed up by telephone by trained medical and nursing teams at 1 week and 1 month after discharge, and then every 3 months until the end of the one-year follow-up period |
| High frequency group | Experimental | Behavioral: High frequency follow-upPatients received routine health education services at discharge and were enrolled in the sample data collection cluster. Patients were followed up by telephone by a trained medical team at 1, 2, 3, and 4 weeks after discharge, and then every month until the end of the one-year follow-up period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old < age < 75 years old;
- Mixed hemorrhoids were diagnosed;
- Internal hemorrhoids ligation + external hemorrhoidectomy
- Complete hospital records;⑤voluntary cooperation in the study
Key exclusion criteria (5 listed)
- The patient had mental illness;
- Serious underlying diseases;
- pregnant or lactating women;
- Serious complications and drug allergy occurred during the treatment;
- Communication difficulties
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 |
|---|---|---|
| High frequency follow-upPatients in the high-frequency group received regular follow-ups at a high frequency after discharge. | Behavioural | High frequency group |
Primary outcome
Quality-of-life SCORES
Time frame: Baseline, weeks 2, 4, 12, 24, 48
By evaluating the quality of life of patients, we proved the effectiveness of different frequency of follow-up methods in improving the quality of life of patients after hemorrhoids surgery.
3 secondary outcomes
pain score
Time frame: Baseline, Day 7, 14, 21, 28
Complication incidence
Time frame: Within six months after discharge
patient satisfaction
Time frame: Baseline, weeks 2, 4, 12, 24, 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No. Based on a strict commitment to participant privacy protection, compliance with the terms of the ethical review protocol, and adherence to the sponsoring institution's policies, IPD from this study will not be shared at this time.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High frequency follow-up in people with Hemorrhoids, run by The Affiliated Hospital of Putian 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chenxing MF Jian, doctoral (139559538950, ptyyjcx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality-of-life SCORES (time frame: Baseline, weeks 2, 4, 12, 24, 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2025.