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NCT Number: NCT07121686

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Putian University

Putian, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Red light exposure

Device

Patients in the red light group received red light therapy concurrently with standard care.

Red-blue light exposure

Device

Patients in the red and blue light group received combined red and blue light therapy concurrently with standard care.

Primary outcomes

  1. 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

Secondary outcomes

  1. Postoperative pain intensity (VAS score)

    Time frame: Baseline, Day 1, 2, 3, 5, 7, and Day 14±2

    Assessed at rest and during defecation

  2. Perianal edema severity (0-6 scale)

    Time frame: Day 1, 2, 3, 5, 7, and Day 14±2

    Evaluated by trained research nurses

  3. Length of hospital stay

    Time frame: From surgery end to discharge (up to 7 days)

    Measured in hours with standardized discharge criteria

  4. Complication incidence

    Time frame: Within 30 days postoperatively

    Classified by Clavien-Dindo grading system

Study contacts

Contact information is provided by the study sponsor or research team.

Chenxing C Jian, doctoral

CONTACT

[email protected]

86-139559538950

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Putian University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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