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

NCT ID: NCT07121686

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2026-08-01

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.

Conditions

Hemorrhoids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Care Group

Standard postoperative care for hemorrhoidectomy patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Red Light Therapy Group

Conventional care plus red light phototherapy.

Group Type: EXPERIMENTAL

Red light exposure

Intervention Type: DEVICE

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

Red-Blue Light Therapy Group

Conventional care plus combined red-blue light phototherapy.

Group Type: EXPERIMENTAL

Red-blue light exposure

Intervention Type: DEVICE

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

Interventions

Red light exposure

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

Intervention Type: DEVICE

Red-blue light exposure

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Putian University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Hospital of Putian University

Putian, , China

Countries

China

Central Contacts

Chenxing C Jian, doctoral

Role: CONTACT

ptyyjcx@126.com

86-139559538950

Other Identifiers

AHPutianU 2024212-1

Identifier Type: -

Identifier Source: org_study_id