Incarcerated Mixed HemorrhoidsEarly Phase 1NCT07183345
Application of Dynamic Pain Assessment and Management System in Perioperative Period of Patients With Incarcerated Mixed Hemorrhoids
A Early Phase 1 study testing Dynamic Pain Assessment and Management System and Routine drug analgesia in people with Incarcerated Mixed Hemorrhoids, run by The Affiliated Hospital of Putian University at 1 site in China.
Trial summary
This study aims to investigate whether the dynamic pain assessment and management system can alleviate postoperative pain in patients with incarcerated mixed hemorrhoids and reduce the incidence of complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Incarcerated Mixed Hemorrhoids
- What is being tested?
- Dynamic Pain Assessment and Management System and Routine drug analgesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 May 2028
- Phase
- Early Phase 1
- 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
- Aged between 18 and 75 years old
- Diagnosed with grade III-IV incarcerated mixed hemorrhoids according to the Goligher classification
- Undergoing standard hemorrhoidectomy
- Receiving simple intraspinal anesthesia
Who cannot join
- Pregnant or lactating patients
- Patients receiving immunotherapy or with coagulation dysfunction
- Patients who need to use various analgesic drugs daily
- Complicated with other anorectal diseases (such as perianal abscess, anal fistula, anal incontinence)
- Complicated with other systemic diseases (cardiac insufficiency; hepatic or renal insufficiency; diabetes mellitus; coagulation disorders; peptic ulcer, etc.)
- Incomplete perioperative clinical data
- Unable to cooperate with follow-up
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: Application of Dynamic Pain Assessment and Management System in Perioperative Period of Patients With Incarcerated Mixed Hemorrhoids: A Single-Center, Prospective, Open-Label, Randomized Controlled Trial
This study aims to investigate whether the dynamic pain assessment and management system can alleviate postoperative pain in patients with incarcerated mixed hemorrhoids and reduce the incidence of complications. A total of 64 eligible patients were enrolled and randomly divided into two groups, with the specific grouping and intervention methods as follows:
① Control Group: Routine drug analgesia and conventional nursing education were adopted.
Read more
② Study Group: Patients were managed with the dynamic pain assessment and management system, which included preoperative administration of analgesic drugs, postoperative traditional Chinese medicine (TCM) fumigation, wrist-ankle acupuncture for pain relief, and personalized nursing education.
The study evaluated the effect of the dynamic pain assessment and management system on postoperative analgesia by comparing the Numerical Rating Scale (NRS) scores for pain, recording the Visual Analogue Scale (VAS) scores for quality of life, and analyzing the incidence of complications among patients in different groups. The primary hypothesis of the study is that, compared with routine pain management methods, the dynamic pain assessment and management system can significantly reduce postoperative pain in patients, improve their quality of life, and decrease the incidence of complications (such as bleeding and urinary retention).
- Conditions
- Incarcerated Mixed Hemorrhoids
- Being tested
- Dynamic Pain Assessment and Management System, Routine drug analgesia
- Keywords
- Pain Management, Preoperative Analgesia, Traditional Chinese Medicine (TCM) Fumigation, Wrist-Ankle Acupuncture (WAA), Dynamic Pain Management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Pain Assessment and Management SystemOther
Personalized nursing education was adopted. These measures include the use of preoperative analgesic drugs, postoperative Traditional Chinese Medicine (TCM) fumigation, and wrist-ankle acupuncture for pain relief.
Routine drug analgesiaDrug
adopted routine drug analgesia and conventional nursing education
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | adopted routine drug analgesia Receives: Drug: Routine drug analgesia |
| study group | Other | Adoption of a Dynamic Pain Assessment and Management System Receives: Other: Dynamic Pain Assessment and Management System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Numerical Rating Scale (NRS)
The NRS uses a linear numerical range of "0 to 10" to represent pain intensity. Patients select the corresponding number based on their own perception, where a score of 0 indicates no pain at all, and a score of 10 represents the most severe pain you can imagine.
Measured: Baseline, Day 1, 3, 5, 7, and Day 14±2
Secondary outcomes (2)
Incidence Rate of Complications
Measurements include the incidence rate of complications such as postoperative hemorrhage and urinary retention
Measured: within 30 days after surgery
Length of Hospital Stay
with hours as the unit, and standardized discharge criteria are adopted.
Measured: from the end of surgery to discharge (a maximum of 7 days)
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 start1 Sep 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incarcerated Mixed 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 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
- NCT07183345
- Sponsor's protocol ID
- putianU-006
- Status last verified
- Jul 2026
- First submitted
- 11 Sep 2025
- Last updated
- 9 Jul 2026
- 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Dynamic Pain Assessment and Management System in Perioperative Period of Patients With Incarcerated Mixed Hemorrhoids: A Single-Center, Prospective, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07183345
- Acronym / sponsor ID
- putianU-006
- Conditions
- Incarcerated Mixed Hemorrhoids
- Keywords
- Pain Management, Preoperative Analgesia, Traditional Chinese Medicine (TCM) Fumigation, Wrist-Ankle Acupuncture (WAA), Dynamic Pain Management
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Putian UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 May 2028 (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 the dynamic pain assessment and management system can alleviate postoperative pain in patients with incarcerated mixed hemorrhoids and reduce the incidence of complications. A total of 64 eligible patients were enrolled and randomly divided into two groups, with the specific grouping and intervention methods as follows:
① Control Group: Routine drug analgesia and conventional nursing education were adopted.
② Study Group: Patients were managed with the dynamic pain assessment and management system, which included preoperative administration of analgesic drugs, postoperative traditional Chinese medicine (TCM) fumigation, wrist-ankle acupuncture for pain relief, and personalized nursing education.
The study evaluated the effect of the dynamic pain assessment and management system on postoperative analgesia by comparing the Numerical Rating Scale (NRS) scores for pain, recording the Visual Analogue Scale (VAS) scores for quality of life, and analyzing the incidence of complications among patients in different groups. The primary hypothesis of the study is that, compared with routine pain management methods, the dynamic pain assessment and management system can significantly reduce postoperative pain in patients, improve their quality of life, and decrease the incidence of complications (such as bleeding and urinary retention).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Drug: Routine drug analgesiaadopted routine drug analgesia |
| study group | Other | Other: Dynamic Pain Assessment and Management SystemAdoption of a Dynamic Pain Assessment and Management System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 75 years old
- Diagnosed with grade III-IV incarcerated mixed hemorrhoids according to the Goligher classification
- Undergoing standard hemorrhoidectomy
- Receiving simple intraspinal anesthesia
Key exclusion criteria (7 listed)
- Pregnant or lactating patients
- Patients receiving immunotherapy or with coagulation dysfunction
- Patients who need to use various analgesic drugs daily
- Complicated with other anorectal diseases (such as perianal abscess, anal fistula, anal incontinence)
- Complicated with other systemic diseases (cardiac insufficiency; hepatic or renal insufficiency; diabetes mellitus; coagulation disorders; peptic ulcer, etc.)
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 |
|---|---|---|
| Dynamic Pain Assessment and Management SystemPersonalized nursing education was adopted. These measures include the use of preoperative analgesic drugs, postoperative Traditional Chinese Medicine (TCM) fumigation, and wrist-ankle acupuncture for pain relief. | Other | study group |
| Routine drug analgesiaadopted routine drug analgesia and conventional nursing education | Drug | control group |
Primary outcome
Pain Numerical Rating Scale (NRS)
Time frame: Baseline, Day 1, 3, 5, 7, and Day 14±2
The NRS uses a linear numerical range of "0 to 10" to represent pain intensity. Patients select the corresponding number based on their own perception, where a score of 0 indicates no pain at all, and a score of 10 represents the most severe pain you can imagine.
2 secondary outcomes
Incidence Rate of Complications
Time frame: within 30 days after surgery
Length of Hospital Stay
Time frame: from the end of surgery to discharge (a maximum of 7 days)
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 9 Jul 2026.
- 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.
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 Early Phase 1 study testing Dynamic Pain Assessment and Management System and Routine drug analgesia in people with Incarcerated Mixed 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 7 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 9 Jul 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jian (+8613959538950, ptyyjcx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Numerical Rating Scale (NRS) (time frame: Baseline, Day 1, 3, 5, 7, and Day 14±2). 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 9 Jul 2026.