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Efficacy of Mepilex Lite Dressings in Treating Anal Pain
Sponsor: Qianfoshan Hospital
Summary
BACKGROUND: Rectal cancer is a common gastrointestinal tumor, and low and intermediate rectal cancer accounts for 90% of rectal cancer. Radiotherapy is one of the important means of rectal cancer treatment, but the radiotoxicity induced by radiotherapy should not be neglected. As normal tissues around the target organ of radiotherapy, the anal canal is damaged by radiation and mucous membrane damage occurs, which is manifested as mucous membrane congestion, edema and ulceration, etc., and pain in the anal area occurs. With the accumulation of radiotherapy dose, the mucosal damage of the anal canal becomes more and more serious, and the anal pain of the patients is severe, which seriously affects the life quality of the patients. Therefore, the main objective of this study is to determine the effectiveness of mepilex lite dressings combined with indomethacin suppositories in the treatment of anal pain in patients undergoing radiotherapy for low and intermediate rectal cancer. METHODS: The study protocol will be a single-blind randomized controlled trial. A randomized grouping method was used to divide the participants into an observation group (n=98) and a control group (n=98). The control group was given routine nursing measures, and the experimental group was given mepilex lite dressings for intra-anal insertion combined with indomethacin suppository for anal administration on the basis of routine nursing measures. The primary outcome indicator was anal pain score. Secondary outcome indicators were anxiety score, sleep quality score and comfort score. Assessments were made at baseline (anal pain NRS score ≥7 in patients undergoing radiotherapy for low to intermediate rectal cancer), day 1, day 7 and day 14 post-intervention. Statistical analyses will be performed using SPSS 25.0 and a significance level of p≤0.05 will be used for all tests.
Official title: Efficacy of Mepilex Lite Dressings Combined with Indomethacin Suppositories in the Treatment of Anal Pain in Patients Undergoing Radiotherapy for Rectal Cancer: Protocol for a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
196
Start Date
2024-12-06
Completion Date
2026-12-06
Last Updated
2025-02-25
Healthy Volunteers
No
Conditions
Interventions
Control group
Give routine nursing measures. Symptom management: Participants were informed that the damage to the anal canal mucosa caused by radiotherapy was mainly manifested as anal pain, and diarrhea could aggravate the symptoms of anal pain. Therefore, the patient should be instructed to monitor the symptoms of diarrhea and anal pain and give timely feedback; Dietary guidance: eat high-protein, high-vitamin, low-slag, low-fiber food, do not eat spicy and irritating food; Medication guidance: Follow the doctor's advice to take the drug orally on time and according to the amount, cooperate with the retention enema, etc., observe the effect of medication; Psychological guidance: strengthen nurse-patient communication, give psychological counseling, and rationally vent anxiety and other emotions. Perianal skin care: Wear loose cotton underwear to keep the perianal area clean and dry.
Experimental group
After the patient emptied urine and feces before going to bed (21:00), the patient was assisted to take the kneeling lateral position, and the anal canal was cleaned with 0.9%Nacl soaked cotton swab, and was fully left to dry. After 30min, the anal pain was relieved. The operator fully exposed the patient's anus and part of the anal canal mucosal lesions with his left thumb and index finger, and applied a 6cm\*6cm adhesive foam dressing on the injured mucosa with his right hand. With the help of a cotton swab, the patient was instructed to take a deep breath, send the foam dressing to 3cm of the anal canal, reveal 2cm, slowly release the left hand, withdraw the cotton swab at the same time the anus automatically retracted, which played a role in securing the dressing, and ask the patient to lie flat and rest, and take it out the next morning (06:00).
Locations (1)
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China