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Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids

This study is not yet open for participant recruitment.
Verified May 2016 by American University of Beirut Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02851940
First Posted: August 2, 2016
Last Update Posted: August 2, 2016
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.
Information provided by (Responsible Party):
American University of Beirut Medical Center
  Purpose
The investigators aim at prospectively comparing procedural pain, adverse events and rebleeding rates of anoscopic rubber band ligation and endoscopic hypertonic saline injection in patients with symptomatic hemorrhoidal disease

Condition Intervention
Hemorrhoids Bleeding Pain Procedure: Rubber Band Ligation Procedure: Hypertonic Saline Infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids: A Randomized Prospective Study

Resource links provided by NLM:


Further study details as provided by American University of Beirut Medical Center:

Primary Outcome Measures:
  • Composite Pain Score [ Time Frame: Days 0 after procedure ]
    Range 0 (no pain) to 10 (maximum pain)

  • Composite Pain Score [ Time Frame: Day 3 after procedure ]
    Range 0 (no pain) to 10 (maximum pain)

  • Composite Pain Score [ Time Frame: Day 7 after procedure ]
    Range 0 (no pain) to 10 (maximum pain)


Secondary Outcome Measures:
  • Bleeding [ Time Frame: Days 1 to 7 after the procedure ]
    If any bleeding is noticed upon defecation

  • Pain Medication Usage [ Time Frame: Days 1 to 7 after the procedure ]
  • Bleeding [ Time Frame: week 1-week 7 post procedure, 3 months, 6 months ]
    If any bleeding is noticed upon defecation

  • Pain [ Time Frame: week 1-week 7 post procedure, 3 months, 6 months ]
    Range 0 (no pain) to 10 (maximum pain)


Estimated Enrollment: 30
Study Start Date: September 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A (Rubber Band Ligation)
15 patients
Procedure: Rubber Band Ligation
Anoscopic rubber band ligation by bedside with patient in the jack-knife position (equipment: anoscope, rubber band applicator)
Experimental: B (Hypertonic Saline Infusion)
15 patients
Procedure: Hypertonic Saline Infusion
Endoscopic retroflexed 3 ml injection of 20% hypertonic saline 1cm above the dentate line (equipment: Flex sig, injection needle, 20% saline)

Detailed Description:

Hemorrhoidal disease is a common encounter in a gastroenterologist's practice. These are often symptomatic, either bleeding or prolapsing. There are no set guidelines in our institution (The American University of Beirut Medical Center - AUBMC) for the treatment of symptomatic hemorrhoidal disease. Two types of treatment are available at our institution: anoscopic rubber band ligation (RBL) or endoscopic sclerotherapy (ESC) with hypertonic (20%) saline. Both methods have been shown to be effective in the literature, with above 75% complete symptomatic relief from a single application after 8-12 months. Post procedural pain of RBL in two randomized studies ranged 40-47%, while different studies showed post procedural pain following ESC to be 12-39%. However no study has ever compared these two therapeutic methods head-on, neither has any study compared both procedures for tolerability and rebleeding rates.

Research design and methods:

This study is a randomized, prospective study conducted at the American University of Beirut Medical Center which will involve 30 patients suffering from symptomatic hemorrhoidal disease requiring therapeutic intervention. Patients meeting inclusion criteria will be randomized using a computer generated randomization list to either Rubber Band Ligation (RBL) or Hypertonic Saline Sclerotherapy as a therapeutic interventional procedure.

- Patients will be approached by their Gastroenterologist during clinic visits and informed about the study. If participants wish to take part in the study, they will be given additional study information, screened for inclusion criteria, and consented by the research assistant or clinic nurse. Recruitment and randomization will occur during the same visit after patient consent in order to properly schedule patients for their therapeutic interventional procedures. All rubber band ligations will be performed by one endoscopist and all sclerotherapies will be performed by the other endoscopist.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age 18+
  • Consent to the study
  • Bleeding grade 1,2 and 3 hemorrhoids

Exclusion Criteria:

  • Age under 18 years
  • Refusal to sign consent
  • Prior surgical and non surgical hemorrhoid procedure/manipulation
  • External hemorrhoids
  • Thrombosed hemorrhoids
  • Active Anal Fissure
  • Active anal fistula
  • Immunocompromised
  • Grade 4 internal hemorrhoids
  • Chronic Pain requiring analgesics
  • Antiplatelets and anticoagulation intake other than Aspirin
  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): NCT02851940


Contacts
Contact: Hussein H Rimmani, MD 009611350000 ext 5909 hhr06@aub.edu.lb

Locations
Lebanon
American University of Beirut Medical Center Not yet recruiting
Beirut, Lebanon
Contact: Ala I Sharara, MD    009611350000 ext 5909    as08@aub.edu.lb   
Contact: Hussein H Rimmani, MD    0096170850967 ext 5909    hhr06@aub.edu.lb   
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
Principal Investigator: Ala I Sharara, MD American University of Beirut Medical Center
  More Information

Responsible Party: American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02851940     History of Changes
Other Study ID Numbers: IM.FD.04
First Submitted: July 26, 2016
First Posted: August 2, 2016
Last Update Posted: August 2, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In the publication

Keywords provided by American University of Beirut Medical Center:
Pain
Bleeding
Hemorrhoids
Band Ligation
hypertonic saline sclerotherapy

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