NCT05959577

Brief Summary

This study aimed to compare the short- and long-term outcomes of stapled hemorrhoidopexy (the procedure for prolapsed hemorrhoids, PPH) with anoplasty versus traditional Ferguson method for the treatment of patients with grade III /IV hemorrhoids.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Aug 2022Dec 2026

Study Start

First participant enrolled

August 17, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

4.4 years

First QC Date

July 16, 2023

Last Update Submit

September 18, 2024

Conditions

Haemorrhoid

Keywords

HemorrhoidFerguson hemorrhoidectomyStapled hemorrhoidopexy

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain

    Recorded with visual analogue scale (VAS)

    6 months

Secondary Outcomes (6)

  • Time to normal life or work

    6 months

  • Post-operative anal hemorrhage

    6 months

  • Wound dehiscence or discharge

    6 months

  • Pruritus

    6 months

  • Urinary retention

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Ferguson hemorrhoidectomy

EXPERIMENTAL

The patients who meet the inclusion and exclusion criteria in this group will undergo Ferguson hemorrhoidectomy

Procedure: Ferguson hemorrhoidectomy

Stapled hemorrhoidopexy with anoplasty

ACTIVE COMPARATOR

The patients who meet the inclusion and exclusion criteria in this group will undergo Stapled hemorrhoidopexy with anoplasty

Procedure: Stapled hemorrhoidopexy with anoplasty

Interventions

Stapled hemorrhoidopexy with anoplastyPROCEDURE

The patients who meet the inclusion and exclusion criteria in this group will undergo Stapled hemorrhoidopexy with anoplasty.

Stapled hemorrhoidopexy with anoplasty
Ferguson hemorrhoidectomyPROCEDURE

Ferguson hemorrhoidectomy

Ferguson hemorrhoidectomy

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 25\~75 years with subjective, severe hemorrhoidal symptoms
  • Graded III-IV hemorrhoid
  • The patients' condition can undergo hemorrhoidectomy
  • ASA status ≤ 3

You may not qualify if:

  • Severe liver cirrhosis
  • Chronic renal disease
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Tung LIANG

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jin-Tung LIANG, MD

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Jin-Tung LIANG, MD

CONTACT

+886-972651432jintung@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2023

First Posted

July 25, 2023

Study Start

August 17, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 20, 2024

Record last verified: 2024-09

Locations

TW(1)