MedTrace Logo

Recurrence Rate of Hemorrhoidal Disease at 10 Years and More After HAL Doppler or HAL-RAR Intervention

NCT04731064 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-05-14

No results posted yet for this study

Summary

The treatment of hemorrhoidal disease involves both instrumental and surgical techniques (hemorrhoidectomy and hemorrhoidopexy). In 1995, a Japanese author proposed a new treatment technique for stage II (spontaneous reintegration prolapse) or III (digital reintegration prolapse) disease, based on Doppler identification of low perirectal arteries followed by their ligation, via a specific windowed rectoscope. Later, a further modification appeared, allowing patients to be treated at more advanced stages, adding vertical mucopexy to the ligatures along the main bundles.

The pathophysiology of hemorrhoidal disease is based on a vascular theory (opening of arteriovenous shunts) and on a mechanical theory (distension of the supporting tissue). Hemorrhoidectomy responds to the first, hemorrhoidopexy to the second. The HAL (Hemorrhoidal Artery Ligation) - RAR (Recto-Anal Repair) technique seeks to treat both vascular (by ligation of the nourishing arteries) and mechanical (by mucopexy of prolapsed bundles) components. The technique first spread to Germany, Russia, Italy, Spain, Australia and England. It has been popularized in France by some authors.

Conditions

  • Hemorrhoidal Disease

Interventions

PROCEDURE

HAL (Hemorrhoidal Artery Ligation) - RAR (Recto-Anal Repair)

The patient is operated on in the first perineal position, under general anesthesia or under locoregional or even local anesthesia, after rectal preparation by simple enema. The HAL equipment included a disposable transparent rectoscope fitted near its end with a centimeter window through which wire stitch ligatures will be made. A light source facilitating the exposure of the internal face of the rectum and a Doppler transducer secured to the base of the rectoscope containing the Doppler system. Everything is connected to a generator which transmits Doppler noises to the surgeon. A printer on the generator makes it possible to map ligatures and note the depth of linked arteries. Equipment includes needle holder, knot pusher, scissors and dissecting forceps. The material for HAL is identical, except for the disposable rectoscope which is more indented at its end and on one side.

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Giorgia Mastronicola · CHU Grenoble Alpes

  • Jean Luc FAUCHERON, MD-PhD · CHU Grenoble Alpes

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-06
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • France

Study Locations

More Related Trials

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 NCT04731064 on ClinicalTrials.gov