Clinical trial NCT06837831: Efficacy of Mepilex Lite Dressings in Treating Anal Pain
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Rectal Cancer, Radiotherapy
Anal Pain
Keywords: Rectal cancer
mepilex lite dressings
indomethacin suppository
anal pain
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Outcome Measures:

1. Anal pain assessment: The degree of anal pain in patients was evaluated using the Numerical Rating Scale (NRS score), with 0-10 points representing different levels of pain. A score of 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain. The higher the score, the more severe the pain. \[22\] For patients with middle and lower rectal cancer undergoing radiotherapy who experienced anal pain and had an NRS score of ≥7, evaluations were conducted on the first day, the seventh day, and the fourteenth day after intervention.
2. Anxiety assessment: The Self-Rating Anxiety Scale (SAS) was used to evaluate the degree of anxiety. The scale consists of 20 items, each scored from 1 to 4 points. The sum of the scores of all items is the total raw score. The SAS standard score is obtained by multiplying the total raw score by 1.25 and rounding to the nearest integer. The higher the score, the more severe the patient's anxiety.
3. Sleep quality assessment: The Pittsburgh Sleep Quality Index (PSQI) was used to evaluate the sleep quality and sleep disorders of the study participants. The PSQI consists of 19 self-rated items and 5 other-rated items.
4. Comfort assessment: The Chinese version of the General Comfort Questionnaire (GCQ) developed by American comfort care expert Kolcaba was adopted. It consists of four dimensions: physical, psychological and spiritual, sociocultural, and environmental, with a total of 28 items.

Eligibility criteria: Inclusion Criteria:

* (1) Patients with low and intermediate rectal cancer confirmed by pathological histologic diagnosis; (2) Patients who received radiotherapy; (3) Anal pain numerical rating scale (Numerical Rating Scale,NRS) ≥7 points; (4) Age ≥18 years; (5) Those who volunteered to participate in this study.

Exclusion Criteria:

1. Allergy, allergy to the drugs used in this study;
2. Mental illness, emotional instability or inability to express their feelings;
3. Combined serious cardiovascular and cerebrovascular diseases, digestive system diseases, blood system diseases and infectious diseases;
4. Previous history of pelvic radiotherapy;
5. Physical strength score (PS score) \> 3 points -

Primary outcomes:
measure: Assessment of anal pain
timeFrame: Patients with rectal pain and NRS score ≥7 were evaluated at baseline，Assessment was performed again on day 1, day 7, and day 14 after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: Heli Shang, undergraduate
role: STUDY_DIRECTOR
References: