HemorrhoidsNCT07121686
Effect of Red and Blue Light Irradiation on Wound Healing After Hemorrhoid Surgery
A study testing Red light exposure and Red-blue light exposure in people with Hemorrhoids, run by The Affiliated Hospital of Putian University at 1 site in China.
Trial summary
The subjects of this study were patients who took mixed haemorrhoidectomy during the period of December 2024 - December 2025 . The haemorrhoidectomy patients were randomly divided into routine group, red light group and red and blue light group, and were given different ways of trauma care, and the number of cases in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Red light exposure and Red-blue light exposure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 1 Aug 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
- Aged 18-75 years
- Diagnosed with Grade III-IV hemorrhoids according to Goligher classification
- Scheduled to undergo rubber band ligation of internal hemorrhoids + external hemorrhoidectomy
- Willing and able to provide written informed consent
- Able to comply with postoperative follow-up and treatment protocol
Who cannot join
- Psychiatric disorders or cognitive impairment
- Uncontrolled chronic diseases:
- Diabetes (HbA1c >7.5%)
- Hypertension (BP >160/100 mmHg)
- Coronary artery disease (NYHA Class III-IV heart failure)
- Concurrent other hemorrhoid treatments (e.g., radiofrequency ablation/sclerotherapy)
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- Inability to complete follow-up (e.g., living too far away, no stable contact)
- Concurrent anal disorders:
- Perianal abscess
- Anal fissure
- Anal fistula
- Hypertrophied anal papilla
- Pregnancy or lactation (for female patients)
- History of phototherapy allergy
- Participation in other clinical trials within 3 months
- For registration, simply copy this structured list directly into the PRS system's eligibility section. The clear formatting will facilitate efficient review.
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: Effect of Red and Blue Light Irradiation on Wound Healing After Hemorrhoid Surgery: A Single - Center Prospective Open - Label Randomized Clinical Trial
The subjects of this study were patients who took mixed haemorrhoidectomy during the period of December 2024 - December 2025 . The haemorrhoidectomy patients were randomly divided into routine group, red light group and red and blue light group, and were given different ways of trauma care, and the number of cases in each group was 105 , with a total of 305 cases. Observe the difference between red and blue light irradiation and routine care on the healing time of postoperative trauma and postoperative complications after haemorrhoidectomy, and evaluate the patients' quality of life and satisfaction with treatment under both red light irradiation and routine care.
Read the detailed description
The subjects of this study were patients who took mixed haemorrhoidectomy during the period of December 2024 - December 2025 . The diagnostic criteria were haemorrhoidal disease diagnosed as degree III-IV according to Goligher's classification. Inclusion criteria were 18 years < age < 75 years; diagnosis of haemorrhoids; internal haemorrhoid ligation + external haemorrhoidectomy. Exclusion criteria were patients with psychiatric disorders; patients with chronic diseases such as diabetes mellitus, hypertension and coronary artery disease; patients who underwent other treatments in addition to haemorrhoidectomy such as haemorrhoidal radiofrequency ablation/ sclerotherapy; patients who were unable to cooperate with the follow-up; and patients with perianal abscess, anal fissure, anal fistulae, and anorectal papillae hypertrophy. The haemorrhoidectomy patients were randomly divided into the conventional group, the red light group and the red and blue light group, and were given different ways of trauma care, and the number of cases in each group was 105 , with a total of 305 cases. The control group was given routine potassium permanganate sitz bath and routine care after internal haemorrhoid ligation + external haemorrhoidectomy to encourage patients to carry out functional exercise in moderation, mainly for anal lifting, buttock lifting and abdominal massage, etc.; the red light group was based on the control group, using red light irradiation for traumatic treatment; the red and blue light group was based on the control group, using red and blue light irradiation for traumatic treatment. Observe the difference between red and blue light irradiation and routine care on the healing time of postoperative trauma and postoperative complications after haemorrhoid surgery, and evaluate the patients' quality of life and satisfaction with treatment under both red light irradiation and routine care. Specific research content is to collect the postoperative data of the three groups of patients, including the recording of surgery-related pain scores, respectively, before the red light intervention and after the intervention of 1 d, 2 d, 3 d, 5 d, 7 d using visual analogue scoring (VAS) to assess the intensity of the patient's pain; the recording of the length of hospital stay; the recording of the degree of oedema of the anal verge were assessed before the red light intervention and after the intervention of 1 d, 2 d, 3 d, 5 d, 7 d, respectively, 0 Score 0: no oedema or slight oedema on the wound, but no impact on life. Score 2: oedema is present in only one area of the wound and is less than 1 cm in diameter, affecting daily activities. 4 points: multiple oedemas with a diameter of 1-2 cm, affecting daily activities. 6 points: multiple oedemas with a diameter of more than 2 cm, seriously affecting daily activities; follow up on the time to complete healing of the wound, quality of life scores, and the patient's satisfaction with the treatment.
- Conditions
- Hemorrhoids
- Being tested
- Red light exposure, Red-blue light exposure
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red light exposureDevice
Patients in the red light group received red light therapy concurrently with standard care.
Red-blue light exposureDevice
Patients in the red and blue light group received combined red and blue light therapy concurrently with standard care.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Care Group | No intervention | Standard postoperative care for hemorrhoidectomy patients. |
| Red Light Therapy Group | Experimental | Conventional care plus red light phototherapy. Receives: Device: Red light exposure |
| Red-Blue Light Therapy Group | Experimental | Conventional care plus combined red-blue light phototherapy. Receives: Device: Red-blue light exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing time
Defined as 100% re-epithelialization assessed by blinded evaluator
Measured: Daily from Day 1 until complete epithelialization (max 28 days post-op)
Secondary outcomes (4)
Postoperative pain intensity (VAS score)
Assessed at rest and during defecation
Measured: Baseline, Day 1, 2, 3, 5, 7, and Day 14±2
Perianal edema severity (0-6 scale)
Evaluated by trained research nurses
Measured: Day 1, 2, 3, 5, 7, and Day 14±2
Length of hospital stay
Measured in hours with standardized discharge criteria
Measured: From surgery end to discharge (up to 7 days)
Complication incidence
Classified by Clavien-Dindo grading system
Measured: Within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group:After internal haemorrhoid ligation + external haemorrhoidectomy, patients were given routine potassium permanganate sitz baths and routine nursing care to encourage patients to carry out functional exercises in moderation, mainly anal lifting, buttock lifting and abdominal massage. Red light group:Based on the control group, red light irradiation wound treatment was used; Red and blue light group: based on the control group, red and blue light irradiation trauma treatment was used;
- Masking
- None (open label)
- Enrolment
- 315 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
- NCT07121686
- Sponsor's protocol ID
- AHPutianU 2024212-1
- Status last verified
- Jul 2025
- First submitted
- 4 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Red and Blue Light Irradiation on Wound Healing After Hemorrhoid Surgery: A Single - Center Prospective Open - Label Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07121686
- Acronym / sponsor ID
- AHPutianU 2024212-1
- Conditions
- Hemorrhoids
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Putian UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 13 Aug 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.
The subjects of this study were patients who took mixed haemorrhoidectomy during the period of December 2024 - December 2025 . The haemorrhoidectomy patients were randomly divided into routine group, red light group and red and blue light group, and were given different ways of trauma care, and the number of cases in each group was 105 , with a total of 305 cases. Observe the difference between red and blue light irradiation and routine care on the healing time of postoperative trauma and postoperative complications after haemorrhoidectomy, and evaluate the patients' quality of life and satisfaction with treatment under both red light irradiation and routine care.
Detailed description
The subjects of this study were patients who took mixed haemorrhoidectomy during the period of December 2024 - December 2025 . The diagnostic criteria were haemorrhoidal disease diagnosed as degree III-IV according to Goligher's classification. Inclusion criteria were 18 years < age < 75 years; diagnosis of haemorrhoids; internal haemorrhoid ligation + external haemorrhoidectomy. Exclusion criteria were patients with psychiatric disorders; patients with chronic diseases such as diabetes mellitus, hypertension and coronary artery disease; patients who underwent other treatments in addition to haemorrhoidectomy such as haemorrhoidal radiofrequency ablation/ sclerotherapy; patients who were unable to cooperate with the follow-up; and patients with perianal abscess, anal fissure, anal fistulae, and anorectal papillae hypertrophy. The haemorrhoidectomy patients were randomly divided into the conventional group, the red light group and the red and blue light group, and were given different ways of trauma care, and the number of cases in each group was 105 , with a total of 305 cases. The control group was given routine potassium permanganate sitz bath and routine care after internal haemorrhoid ligation + external haemorrhoidectomy to encourage patients to carry out functional exercise in moderation, mainly for anal lifting, buttock lifting and abdominal massage, etc.; the red light group was based on the control group, using red light irradiation for traumatic treatment; the red and blue light group was based on the control group, using red and blue light irradiation for traumatic treatment. Observe the difference between red and blue light irradiation and routine care on the healing time of postoperative trauma and postoperative complications after haemorrhoid surgery, and evaluate the patients' quality of life and satisfaction with treatment under both red light irradiation and routine care. Specific research content is to collect the postoperative data of the three groups of patients, including the recording of surgery-related pain scores, respectively, before the red light intervention and after the intervention of 1 d, 2 d, 3 d, 5 d, 7 d using visual analogue scoring (VAS) to assess the intensity of the patient's pain; the recording of the length of hospital stay; the recording of the degree of oedema of the anal verge were assessed before the red light intervention and after the intervention of 1 d, 2 d, 3 d, 5 d, 7 d, respectively, 0 Score 0: no oedema or slight oedema on the wound, but no impact on life. Score 2: oedema is present in only one area of the wound and is less than 1 cm in diameter, affecting daily activities. 4 points: multiple oedemas with a diameter of 1-2 cm, affecting daily activities. 6 points: multiple oedemas with a diameter of more than 2 cm, seriously affecting daily activities; follow up on the time to complete healing of the wound, quality of life scores, and the patient's satisfaction with the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Control group:After internal haemorrhoid ligation + external haemorrhoidectomy, patients were given routine potassium permanganate sitz baths and routine nursing care to encourage patients to carry out functional exercises in moderation, mainly anal lifting, buttock lifting and abdominal massage. Red light group:Based on the control group, red light irradiation wound treatment was used; Red and blue light group: based on the control group, red and blue light irradiation trauma treatment was used;
| Arm | Type | Receives |
|---|---|---|
| Conventional Care Group | No intervention | –Standard postoperative care for hemorrhoidectomy patients. |
| Red Light Therapy Group | Experimental | Device: Red light exposureConventional care plus red light phototherapy. |
| Red-Blue Light Therapy Group | Experimental | Device: Red-blue light exposureConventional care plus combined red-blue light phototherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-75 years
- Diagnosed with Grade III-IV hemorrhoids according to Goligher classification
- Scheduled to undergo rubber band ligation of internal hemorrhoids + external hemorrhoidectomy
- Willing and able to provide written informed consent
- Able to comply with postoperative follow-up and treatment protocol
Key exclusion criteria (16 listed)
- Psychiatric disorders or cognitive impairment
- Uncontrolled chronic diseases:
- Diabetes (HbA1c >7.5%)
- Hypertension (BP >160/100 mmHg)
- Coronary artery disease (NYHA Class III-IV heart failure)
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 |
|---|---|---|
| Red light exposurePatients in the red light group received red light therapy concurrently with standard care. | Device | Red Light Therapy Group |
| Red-blue light exposurePatients in the red and blue light group received combined red and blue light therapy concurrently with standard care. | Device | Red-Blue Light Therapy Group |
Primary outcome
Wound healing time
Time frame: Daily from Day 1 until complete epithelialization (max 28 days post-op)
Defined as 100% re-epithelialization assessed by blinded evaluator
4 secondary outcomes
Postoperative pain intensity (VAS score)
Time frame: Baseline, Day 1, 2, 3, 5, 7, and Day 14±2
Perianal edema severity (0-6 scale)
Time frame: Day 1, 2, 3, 5, 7, and Day 14±2
Length of hospital stay
Time frame: From surgery end to discharge (up to 7 days)
Complication incidence
Time frame: Within 30 days postoperatively
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 13 Aug 2025.
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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 Red light exposure and Red-blue light exposure 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 5 inclusion and 16 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 13 Aug 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 C Jian, doctoral (86-139559538950, ptyyjcx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing time (time frame: Daily from Day 1 until complete epithelialization (max 28 days post-op)). 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 13 Aug 2025.