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Ligation and Hemorrhoidopexy Technique Versus Ligation of Hemorrhoidal Arteries Using Ultrasound for Hemorrhoids

This study is currently recruiting participants.
Verified October 2017 by Perivoliotis Konstantinos, Larissa University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03298997
First Posted: October 2, 2017
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Thessaly
Information provided by (Responsible Party):
Perivoliotis Konstantinos, Larissa University Hospital
  Purpose
The purpose of this study is to compare two techniques for treating hemorrhoids, the ligation and hemorrhoidopexy technique and the conventional ligation of hemorrhoidal arteries using ultrasound, in patients with non-complicated hemorrhoids.

Condition Intervention
Hemorrhoids Procedure: Ligation and Hemorrhoidopexy Procedure: Ultrasound Guided Ligation of Hemorrhoidal Arteries

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Blinding will exist at the level of the patient and the investigator who will record the data postoperatively, regarding the surgical technique applied. There will be no blinding at the level of the surgeon and the anesthesiologist.
Primary Purpose: Treatment
Official Title: Comparison Between the Ligation and Hemorrhoidopexy Technique and the Conventional Ligation of Hemorrhoidal Arteries Using Ultrasound: a Prospective, Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Perivoliotis Konstantinos, Larissa University Hospital:

Primary Outcome Measures:
  • Symptoms Remission Rate [ Time Frame: 1 month postoperatively ]

    The primary endpoint of the present study, is the identification of difference in the symptoms remission rate, within one month postoperatively, between the ligation and hemorrhoidopexy technique and the conventional ligation of hemorrhoidal arteries using ultrasound, in patients with non-complicated hemorrhoidal disease.

    If the symptoms are treated then it will be defined as=1 'YES' If the symptoms are not treated then it will be defined as=0 'NO'



Secondary Outcome Measures:
  • Operative time [ Time Frame: Intraoperative period ]
    The total operative time will be recorded. Measurement unit: minutes

  • Postoperative mobilization time [ Time Frame: Maximum time frame 24 hours postoperatively ]
    The postoperative mobilization time of the patient will be recorded. Measurement unit: hours

  • Onset of oral feeding [ Time Frame: Maximum time frame 24 hours postoperatively ]
    The time that the patient started oral feeding will be recorded. Measurement unit: hours

  • Postoperative pain level at 12 hours [ Time Frame: 12 hours postoperatively ]
    Postoperative pain level at 12 hours after surgery, quantified with the use of the Visual analogue scale (VAS) scale.

  • Hypotension [ Time Frame: Maximum time frame 24 hours postoperatively ]
    Occurrence of postoperative hypotension. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Nausea [ Time Frame: Maximum time frame 24 hours postoperatively ]
    Occurrence of postoperative nausea. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Vomiting [ Time Frame: Maximum time frame 24 hours postoperatively ]
    Occurrence of postoperative vomiting. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Headache [ Time Frame: Maximum time frame 24 hours postoperatively ]
    Occurrence of postoperative headache. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Urinary retention [ Time Frame: Maximum time frame 24 hours postoperatively ]
    Occurrence of postoperative urinary retention. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Bleeding at the operative site [ Time Frame: Maximum time frame 24 hours postoperatively ]
    Occurrence of postoperative bleeding at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Postoperative discharge time [ Time Frame: Maximum time frame 48 hours postoperatively ]

    Postoperative time that the patient can be safely discharged. Measurement unit: hours.

    The patient will be discharged, when it is ensured that is medically safe to be released. In particular, as the exit time of the patient, will be regarded the time that the patient will fulfill the Clinical Discharge Criteria. More specifically, the patient should meet the following : steady vital signs, be oriented, without nausea or vomiting, mobilized with a steady gait, without a significant bleeding.


  • Postoperative pain level at 7 days [ Time Frame: 7 days postoperatively ]
    Postoperative pain level at 7 days after surgery, quantified with the use of the VAS scale.

  • Oedema at the operative site [ Time Frame: 7 days postoperatively ]
    Occurrence of postoperative oedema at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Hematoma at the operative site [ Time Frame: 7 days postoperatively ]
    Occurrence of postoperative hematoma at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Infection at the operative site [ Time Frame: 7 days postoperatively ]
    Occurrence of postoperative infection at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Stenosis at the operative site [ Time Frame: 7 days postoperatively ]
    Occurrence of postoperative stenosis at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Postoperative return to work time [ Time Frame: Postoperative period up to 1 month ]
    The time that the patient resumed his work or normal activities will be recorded. Measurement unit: days

  • Pruritus [ Time Frame: 1 year postoperatively ]
    Occurrence of postoperative pruritus at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Mucosal proptosis [ Time Frame: 1 year postoperatively ]
    Occurrence of postoperative mucosal proptosis at the operative site. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Perianal nodules [ Time Frame: 1 year postoperatively ]
    Occurrence of postoperative perianal nodules. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Constipation [ Time Frame: 1 year postoperatively ]
    Occurrence of postoperative constipation. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Tenesmus [ Time Frame: 1 year postoperatively ]
    Occurrence of tenesmus. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Reoperation [ Time Frame: 1 year postoperatively ]
    Occurrence of reoperation. If the patient is reoperated, then it will be defined as=1 'YES' If the patient is not reoperated, then it will be defined as=0 'NO'

  • Disease recurrence rate [ Time Frame: 1 year postoperatively ]
    Disease recurrence rate If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

  • Satisfaction level [ Time Frame: 1 year postoperatively ]
    Satisfaction level measured at a 0-10 scale

  • Difference in the quality of life of the patient [ Time Frame: Preoperatively, 1 month postoperatively and 1 year postoperatively ]
    Difference in the quality of life of the patient, at 1 month and 1 year postoperatively, compared to the respective preoperative measurements, based on the Short Form 36 (SF-36) questionnaire, weighted for the Greek population.


Estimated Enrollment: 60
Actual Study Start Date: October 1, 2017
Estimated Study Completion Date: November 22, 2019
Estimated Primary Completion Date: November 22, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ligation and Hemorrhoidopexy

The patient will be placed in the Lloyd-Davies position. Provision of a sterile field, using a 10% povidone iodine solution. Rectal dilatation will be performed with a 10% xylocaine gel. Introduction of a proctoscope. Identification of the hemorrhoidal nodules (3rd, 7th, 11th hour). Confirmation of the hemorrhoidal artery location, through palpation. Ligation of the hemorrhoidal nodules using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).

Placement of a fixative suture in the hemorrhoidal nodule and then performance of hemorrhoidopexy Placement of a hemostatic gauze in the surgical field. Prior to operation, the patients will be submitted to pudendal nerve block. Using an atraumatic 25 Gauge (G) needle, a 20ml lidocaine solution (diluted with saline in a 1:1 rate) will be administered bilaterally, medially to the ischial tuberosity.

10 minutes before the operation, the patient will receive 1-2.5mg midazolam and 0.1-0.2 mg fentanyl.

Procedure: Ligation and Hemorrhoidopexy

Identification through palpation and ligation of the hemorrhoidal nodules (3rd, 7th, 11th hour), using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).

Prior to operation, the patients will be submitted to pudendal nerve block.

Active Comparator: Ultrasound Guided Ligation of Hemorrhoidal Arteries

The patient will be placed in the Lloyd-Davies position. Provision of a sterile field, using a 10% povidone iodine solution. Rectal dilatation will be performed with a 10% xylocaine gel. Use of a proctoscope combined with a Doppler sensor. After the hemorrhoidal artery localization, Z ligations will be placed, using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).

The proper artery ligation will be confirmed by the absence of the Doppler signal.

In the presence of residual hemorrhoidal tissue hemorrhoidopexy will be performed, by applying a continuous suture.

Placement of a hemostatic gauze in the surgical field. Prior to operation, the patients will be submitted to spinal anesthesia. Using an atraumatic 25 Gauge (G) needle, a levobupivacaine 5mg/ml and fentanyl 25mg solution, will be administered at the height of lumbar (L)2-L3 or L3-L4.

Procedure: Ultrasound Guided Ligation of Hemorrhoidal Arteries

Ultrasound guided identification and ligation of the hemorrhoidal arteries, using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).

Prior to operation, the patients will be submitted to spinal anesthesia.


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Μale or female
  • Age: 18 to 80 years
  • American Society of Anesthesiologists (ASA) score: I and II
  • Grade I, II, and III hemorrhoids

Exclusion Criteria:

  • Acute perianal diseases, such as perianal abscesses, complicated hemorrhoids (e.g., thrombosis) and acute anal fissure
  • Malignant perianal disorders
  • Patient age ≥ 80 years
  • ASA score ≥ ΙΙΙ
  • Presence of inflammatory bowel disease
  • History of a previous rectoanal operation
  • Presence of a clinically significant cardiovascular, respiratory, renal, hepatic or metabolic disorder. Furthermore, diseases, such as obesity, psychiatric disorders or gastrointestinal disorders constitute exclusion criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03298997


Contacts
Contact: Konstantinos Perivoliotis, MD, MSc 00306944113329 kperi19@gmail.com
Contact: Konstantinos Tepetes, Professor 00302413502804 tepetesk@gmail.com

Locations
Greece
Department of Surgery, University Hospital of Larissa Recruiting
Lárisa, Larissa, Greece, 41110
Contact: Konstantinos Perivoliotis, MD, MSc    0030694411329    kperi19@gmail.com   
Contact: Konstantinos Tepetes, Professor    00302413502804    tepetesk@gmail.com   
Principal Investigator: Konstantinos Perivoliotis, MD, MSc         
Sponsors and Collaborators
Larissa University Hospital
University of Thessaly
Investigators
Study Director: Konstantinos Tepetes, Professor Department of Surgery, University Hospital of Larissa
  Study Documents (Full-Text)

Documents provided by Perivoliotis Konstantinos, Larissa University Hospital:
Study Protocol  [PDF] October 3, 2017
Informed Consent Form  [PDF] October 3, 2017

  More Information

Publications:

Responsible Party: Perivoliotis Konstantinos, Perivoliotis Konstantinos MD, MSc Principal Investigator, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT03298997     History of Changes
Other Study ID Numbers: Hemorrhoids RCT
First Submitted: September 22, 2017
First Posted: October 2, 2017
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Perivoliotis Konstantinos, Larissa University Hospital:
Hemorrhoids
Ligation
Ultrasound
Prospective
Randomized Controlled Trial

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases