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

NCT04731064 | Recruiting

• 1 other identifier: 38RC20.283
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The rate of recurrence leading to a re-intervention within 10 years of the intervention.

  10 years

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients operated for a disease in the digestive surgery and emergency departments will be included, provided they are not opposed.

You may qualify if:

• Patient operated for hemorrhoidal disease for 10 or more
• Age 18 and over
• Informed patients

You may not qualify if:

• Patient opposition
• Minor patient

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble-alpes

Grenoble, France

RECRUITING

MeSH Terms

Interventions

Retinoic Acid Receptor alpha

Intervention Hierarchy (Ancestors)

Receptors, Retinoic Acid; Receptors, Cytoplasmic and Nuclear; Proteins; Amino Acids, Peptides, and Proteins; Transcription Factors

Study Officials

• Giorgia Mastronicola

  CHU Grenoble Alpes

  PRINCIPAL INVESTIGATOR

• Jean Luc FAUCHERON, MD-PhD

  CHU Grenoble Alpes

  STUDY DIRECTOR

Central Study Contacts

Giorgia Mastronicola, MD

CONTACT

0033476767079; GMastronicola@chu-grenoble.fr

Fatah TIDADINI

CONTACT

0033476767079; FTidadini@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: January 29, 2021
• Study Start: January 6, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Locations

FR (1)