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HAL-RAR Technique for Treating Hemorrhoids

NCT04778124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2021-03-02

No results posted yet for this study

Summary

A wide variety of methods has been proposed for treating hemorrhoidal disease with excisional hemorrhoidectomy remaining the gold standard. The aim of this trial is to assess the safety and effectiveness of the HAL-RAR technique in treating hemorrhoidal disease. Arterial ligation was performed by using the highest doppler signal to locate the site of the hemorrhoidal artery in combination with RAR in order to reposition redundant rectal mucosa/submucosa that prolapses to its original anatomical location, leading to resolution of symptoms.

This is a retrospective study from January 2010 to November 2019 of patients who underwent HAL-RAR for hemorrhoidal disease. Demographics, degree of disease, length of hospital stay, postoperative pain, complications (urinary retention, dyschezia, bleeding, necrosis of a hemorrhoid, anal discomfort, sensation of fullness) and recurrence were recorded. Patients were followed-up at postoperative day 1 and 8, and at 1, 6 and 12 months. The main outcome of the study was recurrence. Secondary outcomes included postoperative complications, postoperative pain and patient-assessed resolution of symptoms.

Conditions

  • Hemorrhoidal Disease

Interventions

PROCEDURE

Hemorrhoidal Arterial Ligation (HAL) and Recto Anal Repair (RAR)

All patients underwent hemorrhoidal artery ligation on multiple sites according to pulsations detected by the doppler transducer and mucopexy (RAR) at the sites of prolapse.

PROCEDURE

Excision of thrombosed hemorrhoid / Hemorrhoidectomy /

One patient with mucosal necrosis of the hemorrhoidal cushion postoperatively underwent hemorrhoidectomy with excision of necrotic tissues.Furthermore, 2 patients who presented with hemorrhoidal thrombosis postoperatively underwent emergency surgery with supplementary excision of the thrombosed hemorrhoid. In addition, 9 patients who experienced recurrence of hemorrhoidal disease after undergoing HAL-RAR surgery, were treated with hemorrhoidectomy according to the Milligan-Morgan procedure.

Sponsors & Collaborators

  • Sismanoglio - Amalia Fleming General Hospital

    collaborator UNKNOWN

  • Amalia Fleming General Hospital

    lead OTHER

Principal Investigators

  • Georgia Dedemadi, MD, PhD · Amalia Fleming Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2019-11-30
Completion
2019-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04778124 on ClinicalTrials.gov