The aim of the data set is to recopilate data about the followin topic: Open excisional haemorrhoidectomy (OEH) remains the standard treatment for advanced haemorrhoidal disease, offering low recurrence but notable postoperative pain. Transanal haemorrhoidal dearterialization (THD) is a less invasive alternative with reduced pain but potentially higher recurrence. This study introduces the Clinical Failure Rate (CFR), an objective definition of failure based on the Haemorrhoidal Disease Symptom Score (HDSS) and the Short Health Scale in HD (SHS-HD), comparing the CFR of OEH and THD at one year.
Methods: A prospective, single-centre, randomised, superiority, open-label trial was conducted in patients with grade III haemorrhoids, assigned to OEH or THD. The primary outcome was relative change at 12 months in HDSS and in SHS-HD from baseline. Additionally, we included a predefined, pragmatic composite endpoint, denominated Clinical Failure Rate (CFR) defined as ≤50% improvement in both HDSS and SHS-HD. Secondary outcomes included postoperative pain, time to return to work, complications and need for reoperation. Based on expected failure of 5% (OEH) and 35% (THD), 25 patients per group were required.
Information about methodology:
Creation of an anonymised database. The data matrix contains the coded variables in columns and the anonymised participants in rows. This is raw data.
Specific information about the data:
List of variables: full names and column headers for tabulated data. Units of measurement. Definition of codes in file List of variables.
Missing data is filling in null.
Ethics approval:
It was obtained in accordance with the principles of the Declaration of Helsinki. The Ethics Committee of Illes Balears approved (Date: 2021-11-24 /No. IB 4725/21PI).
Consent to participate:
Informed consent was obtained from all individual participants included in the study.
Conflict of interest:
The authors report no conflict of interest in this work and declare no competing interests. This article has not been presented or published elsewhere, and no financial support has been obtained in its preparation.
ClinicalTrial number: NCT06420986