Comparison of Clinical Effects Between Routine and High-frequency Follow-up After Hemorrhoids Surgery

NCT07183332 | Not Yet Recruiting DMC

• 1 other identifier: PutianU-009
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhoids

Keywords

Hemorrhoids; Follow-up; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Quality-of-life SCORES

  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.

  Baseline, weeks 2, 4, 12, 24, 48

Secondary Outcomes (3)

• pain score

  Baseline, Day 7, 14, 21, 28

• Complication incidence

  Within six months after discharge

• patient satisfaction

  Baseline, weeks 2, 4, 12, 24, 48

Study Arms (2)

Conventional group

NO INTERVENTION

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

EXPERIMENTAL

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.

Behavioral: High frequency follow-up

Interventions

High frequency follow-up BEHAVIORAL

Patients in the high-frequency group received regular follow-ups at a high frequency after discharge.

High frequency 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:

• years old \< age \< 75 years old;
• Mixed hemorrhoids were diagnosed;
• Internal hemorrhoids ligation + external hemorrhoidectomy
• Complete hospital records;⑤voluntary cooperation in the study

You may not qualify if:

• The patient had mental illness;
• Serious underlying diseases;
• pregnant or lactating women;
• Serious complications and drug allergy occurred during the treatment;
• Communication difficulties

Sponsors & Collaborators

• The Affiliated Hospital of Putian University: lead

Study Sites (1)

Putian University Affiliated Hospital

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 MF Jian, doctoral

CONTACT

139559538950; ptyyjcx@126.com

Study Design

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

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 19, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)