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

NCT02216305 | Completed

• 1 other identifier: HAL-RAR Plató 2.0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

HYPOTHESIS

1. 1.HAL- RAR causes a lower immediate postoperative pain compared with excision hemorrhoidectomy.
2. 2.HAL - RAR achieves similar immediate and long term results compared to the excision hemorrhoidectomy in the control of hemorrhoidal symptoms.
3. 3.The complication rate of HAL- RAR is low and similar to excision hemorrhoidectomy.
4. 4.Compare postoperative pain of both techniques.
5. 5.Assess the short and long-term control of hemorrhoidal symptoms by HAL- RAR technique, and compare the results with those of the excision hemorrhoidectomy.
6. 6.Evaluate and compare the rate of complications of both techniques.
7. 7.Assess the quality of life of patients before and after treatment.

Conditions

Hemorrhoids; Pain, Postoperative

Keywords

HAL-RAR; Hemorrhoids; Hemorrhoid artery ligation; Anal repair; Quality of Life; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Immediate postoperative pain

  All patients will complete a diary testing global postoperative pain every day, measured on a numerical scale from 0 to 10 during the first 15 days.

  up to first 15 postoperative days

Secondary Outcomes (1)

• Long-term control of hemorrhoidal symptoms

  1, 6, 12 and 24 months after surgery

Other Outcomes (1)

• SF-36 Quality of life score

  Preoperative, 6 and 12 months after surgery

Study Arms (2)

Hemorrhoidectomy

ACTIVE COMPARATOR

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: Hemorrhoidectomy

HAL-RAR

ACTIVE COMPARATOR

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.

Procedure: HAL-RAR

Interventions

Hemorrhoidectomy PROCEDURE

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

Hemorrhoidectomy

HAL-RAR PROCEDURE

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.

Also known as: Hemorrhoid Artery Ligation and Rectoanal Repair

HAL-RAR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptomatic grade III or IV hemorrhoids (bleeding, pain, itching, soiling or prolapse) that are eligible for surgical treatment with both methods.

You may not qualify if:

• Associated recto-anal pathology such as acute thrombosed hemorrhoid, anal fissure, perianal fistula, perianal abscess, rectal prolapse, fecal incontinence or anal stenosis.
• Prior anorectal surgery .
• Systemic pathology that could alter the outcome of the surgery as coagulopathies, chronic pain with continued consumption of analgesics.
• Age younger than 18 or older than 80 years, socio-pathology or inability to understand the study objectives

Sponsors & Collaborators

• Hospital Plató: lead

Study Sites (1)

Hospital Plató

Barcelona, Catalonia, 08006, Spain

Location

Related Publications (2)

• Johanson JF, Sonnenberg A. The prevalence of hemorrhoids and chronic constipation. An epidemiologic study. Gastroenterology. 1990 Feb;98(2):380-6. doi: 10.1016/0016-5085(90)90828-o.

  PMID: 2295392 BACKGROUND

• Elmer SE, Nygren JO, Lenander CE. A randomized trial of transanal hemorrhoidal dearterialization with anopexy compared with open hemorrhoidectomy in the treatment of hemorrhoids. Dis Colon Rectum. 2013 Apr;56(4):484-90. doi: 10.1097/DCR.0b013e31827a8567.

  PMID: 23478616 BACKGROUND

MeSH Terms

Conditions

Hemorrhoids; Pain, Postoperative; Postoperative Complications

Interventions

Hemorrhoidectomy

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Fernando Carvajal, Dr

  Hospital Plató Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 13, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)