An interventional study of Red light exposure and Red-blue light exposure in Hemorrhoids, sponsored by The Affiliated Hospital of Putian University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by The Affiliated Hospital of Putian University · Not applicable, Interventional, and Treatment
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.
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.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 315 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →The Affiliated Hospital of Putian University is the lead sponsor of 14 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
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A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard postoperative care for hemorrhoidectomy patients.
Conventional care plus red light phototherapy.
Device: Red light exposure
Conventional care plus combined red-blue light phototherapy.
Device: Red-blue light exposure
Patients in the red light group received red light therapy concurrently with standard care.
Patients in the red and blue light group received combined red and blue light therapy concurrently with standard care.
Wound healing time
Defined as 100% re-epithelialization assessed by blinded evaluator
Time frame: Daily from Day 1 until complete epithelialization (max 28 days post-op)
Postoperative pain intensity (VAS score)
Assessed at rest and during defecation
Time frame: Baseline, Day 1, 2, 3, 5, 7, and Day 14±2
Perianal edema severity (0-6 scale)
Evaluated by trained research nurses
Time frame: Day 1, 2, 3, 5, 7, and Day 14±2
Length of hospital stay
Measured in hours with standardized discharge criteria
Time frame: From surgery end to discharge (up to 7 days)
Complication incidence
Classified by Clavien-Dindo grading system
Time frame: Within 30 days postoperatively
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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The Affiliated Hospital of Putian University