NCT07719881

Brief Summary

This observational multicenter study aims to develop and validate the Hemorrhoidectomy Quality Assessment Scale (HeQAS), a histopathological tool designed to assess the technical quality of excisional hemorrhoidectomy. The project includes a methodological validation phase using blinded assessment of surgical specimens by expert pathologists, followed by a clinical cohort phase comparing micro-open excisional hemorrhoidectomy (microOEH) and conventional open excisional hemorrhoidectomy (OEH) in real-world practice. The study will evaluate the reproducibility and applicability of HeQAS and explore whether microOEH is associated with lower histological tissue damage than conventional OEH.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jan 2026Jan 2027

Study Start

First participant enrolled

January 1, 2026

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 17, 2026

Last Update Submit

July 17, 2026

Conditions

HemorrhoidectomyHemorrhoid

Keywords

excisional hemorrhoidecotmySurgical qualityTechnical skillValidation studySurgical assessment toolHeQAS

Outcome Measures

Primary Outcomes (1)

  • HeQAS total histopathological score

    Total score of the Hemorrhoidectomy Quality Assessment Scale (HeQAS), a composite histopathological measure of technical quality of excisional hemorrhoidectomy specimens, calculated from predefined items related to specimen size, muscle involvement at the margin and deep surface, depth and extent of thermal injury, and distance from the deepest hemorrhoidal vessels to the resection margin. Higher scores indicate greater histological tissue damage and lower technical quality.

    At the time of histopathological assessment of the surgical specimen (within routine pathology processing after surgery).

Secondary Outcomes (5)

  • Postoperative pain at day 7 (VAS)

    7 days after surgery

  • Early postoperative complications within 30 days

    Within 30 days after surgery

  • Clinical failure rate at 12 months

    12 months after surgery

  • Total analgesic consumption during the first 15 days after surgery

    15 days after surgery

  • Wexner incontinence score at follow-up

    a year after surgery

Study Arms (2)

Micro-open excisional hemorrhoidectomy (microOEH)

Patients undergoing micro-open excisional hemorrhoidectomy in routine clinical practice.

Conventional open excisional hemorrhoidectomy (OEH)

Patients undergoing conventional open excisional hemorrhoidectomy in routine clinical practice.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing excisional hemorrhoidectomy (either micro-open excisional hemorrhoidectomy or conventional open excisional hemorrhoidectomy) in routine clinical practice at the participating centers, whose surgical specimens and clinical data are available for standardized histopathological assessment and follow-up, according to the study protocol.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Son Llatzer

Palma de Mallorca, Balearic Islands, 07190, Spain

Location

Hospital Parc Taulí

Sabadell, Spain

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Colorectal Surgeon

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 22, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

July 22, 2026

Record last verified: 2026-07

Locations

ES(2)