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

NCT07121686 | Not Yet Recruiting DMC

• 1 other identifier: AHPutianU 2024212-1
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• Wound healing time

  Defined as 100% re-epithelialization assessed by blinded evaluator

  Daily from Day 1 until complete epithelialization (max 28 days post-op)

Secondary Outcomes (4)

• Postoperative pain intensity (VAS score)

  Baseline, Day 1, 2, 3, 5, 7, and Day 14±2

• Perianal edema severity (0-6 scale)

  Day 1, 2, 3, 5, 7, and Day 14±2

• Length of hospital stay

  From surgery end to discharge (up to 7 days)

• Complication incidence

  Within 30 days postoperatively

Study Arms (3)

Conventional Care Group

NO INTERVENTION

Standard postoperative care for hemorrhoidectomy patients.

Red Light Therapy Group

EXPERIMENTAL

Conventional care plus red light phototherapy.

Device: Red light exposure

Red-Blue Light Therapy Group

EXPERIMENTAL

Conventional care plus combined red-blue light phototherapy.

Device: Red-blue light exposure

Interventions

Red light exposure DEVICE

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

Red Light Therapy Group

Red-blue light exposure DEVICE

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

Red-Blue Light Therapy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Hospital of Putian University: lead

Study Sites (1)

Affiliated Hospital of Putian University

Putian, China

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Chenxing C Jian, doctoral

CONTACT

86-139559538950; ptyyjcx@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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;

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 13, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-07

Locations

CN (1)