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NCT Number: NCT07183332

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Putian University Affiliated Hospital

Putian, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High frequency follow-up

Behavioral

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

Primary outcomes

  1. 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

  1. pain score

    Time frame: Baseline, Day 7, 14, 21, 28

    The assessment is conducted using the Numerical Rating Scale for Pain (NRS), which requires patients to select an integer (whole number) from 0 to 10 that best describes their pain. 0 typically indicates "no pain", while 10 represents "the most severe pain imaginable".

  2. Complication incidence

    Time frame: Within six months after discharge

    Record the recurrence of hemorrhoids and the occurrence of complications in the patients in the medium and long term. The complications mainly include: incision infection, wound bleeding, and urinary retention.

  3. patient satisfaction

    Time frame: Baseline, weeks 2, 4, 12, 24, 48

    The Patient Satisfaction Questionnaire Short Form (PSQ-18) was used for measurement during the telephone follow-up period.

Study contacts

Contact information is provided by the study sponsor or research team.

Chenxing MF Jian, doctoral

CONTACT

[email protected]

139559538950

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Putian University

Other

Registry information

Official study title

Comparison of Clinical Effects Between Routine and High-frequency Follow-up After Hemorrhoids Surgery: a Single-center, Prospective, Open-label, Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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