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

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2015 by Hospital Plató
Sponsor:
Information provided by (Responsible Party):
Hospital Plató
ClinicalTrials.gov Identifier:
NCT02216305
First received: August 12, 2014
Last updated: November 18, 2015
Last verified: November 2015
  Purpose

HYPOTHESIS

  1. HAL- RAR causes a lower immediate postoperative pain compared with erxcision 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.

MATERIAL AND METHODS

The trial was subjected to evaluation and accepted by the Ethics Committee of the Fundació Unió Catalana d'Hospitals (Catalonian Union of Hospitals Foundation).

All patients with grade III and IV hemorrhoids that are eligible for surgical treatment with both methods who agree to participate in the study, will be included in the prospective randomized trial. All patients will be required to sign the specific informed consent.

Patients who are suitable for treatment with both techniques will be randomly assigned to the surgical technique.

Inclusion criteria:

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

Exclusion criteria:

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

All surgeries are performed on an outpatient basis under regional anesthesia and sedation for the same team of three surgeons. Preoperative preparation consists of a cleansing enema and no prophylactic antibiotics will be administered.

Both techniques will be performed in "Jack -Knife" position. The 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 hemorroidal base with absorbable suture. Once completed hemorrhoidectomy a perianal block is performed with bupivacaine/epinephrine.

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 hemorroid. Other procedures will not be associated, if necessary, the patient will be excluded from the study .

The patient will be discharged if adequate pain control, oral tolerance and spontaneous diuresis is achieved, and after examination by the surgeon in order to discard immediate complications. The ambulatory treatment consists of an osmotic laxative (magnesium hydroxide ), oral analgesia with paracetamol/tramadol ( 325mg/37.5mg ) every 6 hours and Dexketoprofen (25 mg) every 8 hours, metamizol (575 mg) may be associated every 8 hours if pain. In case of persistent pain, the patient will be examinated in emergency room.

EVALUATION OF RESULTS A power analysis was performed to assess the study sample size. Choosing a power of 0.8 and a confidence interval of 95% α-error of 0.05, we calculated that 26 patients were needed in each arm. We increased this number up to 30 to increase reliability of the study.

All patients will be evaluated with a validated questionnaire of 36 questions on quality of life ( SF-36 ) and specific questions about specific symptoms of hemorrhoidal disease (pain, itching , bleeding, soiling and hemorrhoidal prolapse reduction ). The questionnaire will be answered before the intervention, after six and twelve months of follow up.

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.

The patients will be assessed on the day of discharge and at 7, 14, and 30 postoperative days. The patients will be evaluated at 6, 12 and 24 postoperative months in the outpatient clinic.


Condition Intervention Phase
Hemorrhoids Pain, Postoperative Procedure: Hemorrhoidectomy Procedure: HAL-RAR Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective and Randomized Trial Comparing Dopplper-Guided Transanal Hemorrhoid Artery Ligation With Recto-anal Repair (HAL-RAR) Versus Excisional Hemorrhoidectomy for the Treatment of Grade III-IV Hemorrhoids

Resource links provided by NLM:


Further study details as provided by Hospital Plató:

Primary Outcome Measures:
  • Immediate postoperative pain [ Time Frame: up to first 15 postoperative days ]
    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.


Secondary Outcome Measures:
  • Long-term control of hemorrhoidal symptoms [ Time Frame: 1, 6, 12 and 24 months after surgery ]
    Specific symptoms of hemorrhoidal disease (pain, itching , bleeding, soiling and hemorrhoidal prolapse reduction) will be evaluated. Te patient will mark in a questionaree the options "yes" or "no" for each item.


Other Outcome Measures:
  • Quality of life [ Time Frame: Preoperative, 6 and 12 months after surgery ]
    All patients will be evaluated with a validated questionnaire of 36 questions on quality of life ( SF-36 )


Estimated Enrollment: 60
Study Start Date: September 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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 hemorroidal base with absorbable suture
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 hemorroidal base with absorbable suture
Active Comparator: 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 hemorroid. Other procedures will not be associated.
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 hemorroid. Other procedures will not be associated.
Other Name: Hemorrhoid Artery Ligation and Rectoanal Repair

Detailed Description:

The classic surgical treatment of hemorrhoidal disease is the excisional hemorrhoidectomy, that consist in the surgical removal of one or more hemorrhoidal cushion, it is considered a safe, radical and definitive treatment; however, it is not exempt of complications and the postoperative pain is considerable. During the last two decades the concept of treatment has evolved to control hemorrhoidal symptoms with less invasive techniques, such as hemorrhoidal bands, arterial ligation Doppler guided hemorrhoidal and more recently, the association of anorectal repair or mucopexia for treating hemorrhoidal mucosal prolapse .

The results of the doppler guided transanal dearterialization and rectoanal repair (HAL-RAR) in the treatment of hemorrhoidal disease, show good control of symptoms, less postoperative pain and low rates of complications in the treatment of grade II, III and IV hemorrhoids.1 -10

The advantages of the HAL- RAR could be more limited in advanced hemorrhoidal disease (stage IV), in this stage have been reported a recurrence rate of up to 38 % 4.

The studies with more patients treated with HAL- RAR are those of Faucheron et al3 (100 patients) and Roka et al6 (77 patients). These studies reported good results in the treatment of grade IV hemorrhoids with a high rate of outpatient treatment, good control of symptoms (89 %) and a low rate of complications. Te complications presented 9% in the immediate postoperative period and 4% in the long term, all were treated conservatively.

Currently there are few prospective randomized studies that demonstrate the results of HAL- RAR compared with open hemorrhoidectomy, the long-term results remain to be demonstrated.

In the literature there are two prospective randomized studies comparing the HAL- RAR with excision hemorrhoidectomy1 -2. In both studies, good results were observed with these techniques with regard to symptom control; postoperative pain and long-term results were similar with both techniques.

The publication of more randomized prospective studies to allow proper evaluation of the results in patients who underwent HAL- RAR is required.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02216305

Contacts
Contact: Fernando Carvajal, Dr. 0034 676983590 fernando.carvajal@hospitalplato.com
Contact: Daniel Troyano daniel.troyano@hospitalplato.com

Locations
Spain
Hospital Plató Recruiting
Barcelona, Catalunya, Spain, 08006
Sponsors and Collaborators
Hospital Plató
Investigators
Principal Investigator: Fernando Carvajal, Dr Hospital Plató Barcelona
  More Information

Responsible Party: Hospital Plató
ClinicalTrials.gov Identifier: NCT02216305     History of Changes
Other Study ID Numbers: HAL-RAR Plató 2.0
Study First Received: August 12, 2014
Last Updated: November 18, 2015

Keywords provided by Hospital Plató:
HAL-RAR
Hemorrhoids
Hemorrhoid artery ligation
Anal repair
Quality of Life
Postoperative Complications

Additional relevant MeSH terms:
Pain, Postoperative
Hemorrhoids
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 22, 2017