Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02851940|
Recruitment Status : Unknown
Verified May 2016 by American University of Beirut Medical Center.
Recruitment status was: Not yet recruiting
First Posted : August 2, 2016
Last Update Posted : August 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids Bleeding Pain||Procedure: Rubber Band Ligation Procedure: Hypertonic Saline Infusion||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids: A Randomized Prospective Study|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: A (Rubber Band Ligation)
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)
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)
- 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)
- 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)
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
|Contact: Hussein H Rimmani, MD||009611350000 ext firstname.lastname@example.org|
|Principal Investigator:||Ala I Sharara, MD||American University of Beirut Medical Center|