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Not yet recruitingNCT07183332Updated Sep 19, 2025

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

An interventional study of High frequency follow-up in Hemorrhoids, sponsored by The Affiliated Hospital of Putian University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by The Affiliated Hospital of Putian University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hemorrhoids

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Keywords

  • Hemorrhoids
  • Follow-up
  • Quality of Life
03

In context

Hemorrhoids

238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.

This study's planned enrollment of 116 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.

Browse Hemorrhoids studies →

Lead sponsor

The Affiliated Hospital of Putian University is the lead sponsor of 14 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
116 participants (estimated)

Study arms

  • No intervention
    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

  • Experimental
    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.

    Behavioral: High frequency follow-up

Interventions

  • BehavioralHigh frequency follow-up

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

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What researchers measure

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.

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

Secondary outcomes

  1. pain score

    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".

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

  2. Complication incidence

    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.

    Time frame: Within six months after discharge

  3. patient satisfaction

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

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

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No — Based on a strict commitment to participant privacy protection, compliance with the terms of the ethical review protocol, and adherence to the sponsoring institution's policies, IPD from this study will not be shared at this time.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07183332
Lead sponsor
The Affiliated Hospital of Putian University
Responsible party
Sponsor
First posted
Sep 19, 2025
Start date
Sep 15, 2025 (estimated)
Primary completion
Aug 14, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Sep 19, 2025

Study contacts

Chenxing MF Jian, doctoral
Contact
ptyyjcx@126.com
139559538950

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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