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Effect of Red and Blue Light Irradiation on Wound Healing After Hemorrhoid Surgery

Effect of Red and Blue Light Irradiation on Wound Healing After Hemorrhoid Surgery: A Single - Center Prospective Open - Label Randomized Clinical Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07121686
Enrollment
315
Registered
2025-08-13
Start date
2025-08-15
Completion date
2026-08-01
Last updated
2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhoids

Brief 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 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.

Interventions

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.

Sponsors

The Affiliated Hospital of Putian University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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;

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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) * 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.

Design outcomes

Primary

MeasureTime frameDescription
Wound healing timeDaily from Day 1 until complete epithelialization (max 28 days post-op)Defined as 100% re-epithelialization assessed by blinded evaluator

Secondary

MeasureTime frameDescription
Postoperative pain intensity (VAS score)Baseline, Day 1, 2, 3, 5, 7, and Day 14±2Assessed at rest and during defecation
Perianal edema severity (0-6 scale)Day 1, 2, 3, 5, 7, and Day 14±2Evaluated by trained research nurses
Length of hospital stayFrom surgery end to discharge (up to 7 days)Measured in hours with standardized discharge criteria
Complication incidenceWithin 30 days postoperativelyClassified by Clavien-Dindo grading system

Countries

China

Contacts

Primary ContactChenxing C Jian, doctoral
ptyyjcx@126.com86-139559538950

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026