Definition and Validation of HeQAS for the Assessment of Technical Quality in Excisional Hemorrhoidectomy

Excisional hemorrhoidectomy remains the standard surgical treatment for advanced hemorrhoidal disease, but there is currently no validated histopathological tool to objectively assess the technical quality of tissue resection. This project aims to develop and validate the Hemorrhoidectomy Quality Assessment Scale (HeQAS), a structured histopathological score designed to evaluate technical quality in excisional hemorrhoidectomy specimens, and then to apply the validated instrument in a real-world comparative clinical setting.

The project is organized into two predefined and sequential components. Study 1 is a multicenter, ambispective, cross-sectional methodological validation study designed to develop, refine, and validate the HeQAS instrument. In this phase, a pilot set of 10 retrospective hemorrhoidectomy specimens will be used to refine item definitions, improve applicability, and create a reference atlas. Afterwards, a validation set of 40 ambispective specimens will be assessed independently and blindly by pathologists from participating centers. The main purpose of this phase is to determine the reproducibility and reliability of the score through inter-observer agreement, intra-observer agreement, and internal consistency analyses. Only specimens with adequate histological quality will be included, and all slides will be pseudonymized and centrally reviewed without access to clinical, surgical, or demographic information.

Study 2 is a multicenter, observational, analytical cohort study performed in routine clinical practice. This phase will include patients undergoing either micro-open excisional hemorrhoidectomy (microOEH) or conventional open excisional hemorrhoidectomy (OEH), with ambispective recruitment of retrospective and prospective cases not previously used in Study 1. A total of 80 patients are planned, with 40 cases in the microOEH group and 40 cases in the conventional OEH group. Surgical indication, operative technique, and postoperative management will not be modified by the study and will remain entirely based on usual clinical practice and physician judgment.

In Study 2, all surgical specimens will undergo standardized histopathological processing according to the protocol established during the validation phase and will be evaluated centrally and blindly using the HeQAS instrument. The primary comparative objective is to assess differences in HeQAS total score between microOEH and conventional OEH, as a measure of tissue resection quality and histological tissue damage. Secondary analyses will explore associations between HeQAS scores and relevant clinical outcomes, including postoperative pain, early and late complications, and clinical failure rate at 12 months. Additional analyses will evaluate potential differences between retrospective and prospective cases and adjust for relevant confounding factors such as age, sex, hemorrhoidal grade, surgeon experience, and center.

The study is observational and non-interventional. It does not assign treatment, alter surgical indications, require additional invasive procedures, or impose visits beyond standard care. Histopathological material and clinical data are obtained as part of routine clinical management, and the research procedures are limited to standardized specimen processing, blinded pathological assessment, and collection of routinely generated clinical data. Overall, the project is intended to provide a reproducible histopathological quality assessment tool for excisional hemorrhoidectomy and to determine whether microOEH is associated with less histological tissue damage than conventional OEH in real-world practice.

Inclusion criteria

• Adult patients undergoing excisional hemorrhoidectomy (micro-open excisional hemorrhoidectomy or conventional open excisional hemorrhoidectomy) at the participating centers.

Availability of the surgical specimen with adequate histopathological preservation for standardized processing and HeQAS assessment.

Availability of routine clinical follow-up data required for outcome assessment (pain, complications, and 12-month clinical status).

Exclusion criteria

Surgical specimens with inadequate fixation, autolysis, or fragmentation that preclude reliable histopathological assessment according to the protocol.

Incidental diagnosis of malignancy (carcinoma) in the surgical specimen.

Intraoperative change of surgical technique that prevents clear assignment to one cohort (micro-open excisional hemorrhoidectomy or conventional open excisional hemorrhoidectomy).

Prior use of the same specimen in the methodological validation study (Study 1) of HeQAS.

-