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HAL-RAR Versus Hemorrhoidectomy in the Treatment of Grade III-IV Hemorrhoids. Prospective, Randomized Trial

NCT02216305 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-03-13

No results posted yet for this study

Summary

HYPOTHESIS

1. HAL- RAR causes a lower immediate postoperative pain compared with excision hemorrhoidectomy.
2. HAL - RAR achieves similar immediate and long term results compared to the excision hemorrhoidectomy in the control of hemorrhoidal symptoms.
3. The complication rate of HAL- RAR is low and similar to excision hemorrhoidectomy.

OBJECTIVES

1. Compare postoperative pain of both techniques.
2. Assess the short and long-term control of hemorrhoidal symptoms by HAL- RAR technique, and compare the results with those of the excision hemorrhoidectomy.
3. Evaluate and compare the rate of complications of both techniques.
4. Assess the quality of life of patients before and after treatment.

Conditions

Interventions

PROCEDURE

Hemorrhoidectomy

Open hemorrhoidectomy may include one to three anal cushions and made according to the Milligan-Morgan technique, with resection of the anal cushion and the external hemorrhoidal epidermal component using electrocautery and ligation of the hemorrhoidal base with absorbable suture

PROCEDURE

HAL-RAR

Hemorrhoidal artery ligation and rectoanal repair will be performed with the AMI minimally invasive surgery device HAL/RAR, and consist in the ligation of the terminal branches of the superior rectal artery with 2-0 absorbable polyglycolic acid suture after identifying the blood flow approximately 3 cm above the dentate line by using Doppler guidance. Subsequently, a running suture was added from the suture point to 5 mm above the dentate line to lift the prolapsing hemorrhoid. Other procedures will not be associated.

Sponsors & Collaborators

  • Hospital Plató

    lead OTHER

Principal Investigators

  • Fernando Carvajal, Dr · Hospital Plató Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Spain

Study Locations

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Entities

Diseases

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 NCT02216305 on ClinicalTrials.gov