Comparison of Clinical Effects Between Routine and High-frequency Follow-up After Hemorrhoids Surgery: a Single-center, Prospective, Open-label, Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Quality-of-life SCORES
Study Overview
Brief Summary
This study aims to investigate whether frequent follow-ups can enhance the quality of life of patients after hemorrhoid surgery and reduce the incidence of complications. A total of 116 eligible patients were randomly and evenly divided into two groups (58 patients in each group): A. The control group: Patients received routine health education services upon discharge and were then followed up by phone at the regular frequency. B. The high-frequency group: Patients received routine health education services upon discharge and were then followed up by phone at a higher frequency. The quality of life of the patients and the incidence of complications were compared to evaluate the clinical effects of different intervention measures. The main hypothesis is that compared to conventional care, frequent follow-ups can significantly improve the quality of life of patients, promote wound healing, and reduce the incidence of complications and disease recurrence.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years old < age < 75 years old;
- •Mixed hemorrhoids were diagnosed;
- •Internal hemorrhoids ligation + external hemorrhoidectomy
- •Complete hospital records;⑤voluntary cooperation in the study
Exclusion Criteria
- •The patient had mental illness;
- •Serious underlying diseases;
- •pregnant or lactating women;
- •Serious complications and drug allergy occurred during the treatment;
- •Communication difficulties
Arms & Interventions
Conventional group
Patients received routine health education services at discharge and were enrolled in the sample data collection cluster. Patients were followed up by telephone by trained medical and nursing teams at 1 week and 1 month after discharge, and then every 3 months until the end of the one-year follow-up period
High frequency group
Patients received routine health education services at discharge and were enrolled in the sample data collection cluster. Patients were followed up by telephone by a trained medical team at 1, 2, 3, and 4 weeks after discharge, and then every month until the end of the one-year follow-up period.
Intervention: High frequency follow-up (Behavioral)
Outcomes
Primary Outcomes
Quality-of-life SCORES
Time Frame: Baseline, weeks 2, 4, 12, 24, 48
By evaluating the quality of life of patients, we proved the effectiveness of different frequency of follow-up methods in improving the quality of life of patients after hemorrhoids surgery.
Secondary Outcomes
- pain score(Baseline, Day 7, 14, 21, 28)
- Complication incidence(Within six months after discharge)
- patient satisfaction(Baseline, weeks 2, 4, 12, 24, 48)