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

Pain Clinical Trial

Official title:

Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids: A Randomized Prospective Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02851940
• Other study ID #: IM.FD.04
• Status: Withdrawn
• Phase: N/A
• Start date: September 2016
• Est. completion date: January 2018

Study information

• Verified date: May 2016
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Hemorrhoids
• Pain

Intervention

Procedure:
• Rubber Band Ligation
Anoscopic rubber band ligation by bedside with patient in the jack-knife position (equipment: anoscope, rubber band applicator)
• Hypertonic Saline Infusion
Endoscopic retroflexed 3 ml injection of 20% hypertonic saline 1cm above the dentate line (equipment: Flex sig, injection needle, 20% saline)

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Pain Score	Range 0 (no pain) to 10 (maximum pain)	Days 0 after procedure
Primary	Composite Pain Score	Range 0 (no pain) to 10 (maximum pain)	Day 3 after procedure
Primary	Composite Pain Score	Range 0 (no pain) to 10 (maximum pain)	Day 7 after procedure
Secondary	Bleeding	If any bleeding is noticed upon defecation	Days 1 to 7 after the procedure
Secondary	Pain Medication Usage		Days 1 to 7 after the procedure
Secondary	Bleeding	If any bleeding is noticed upon defecation	week 1-week 7 post procedure, 3 months, 6 months
Secondary	Pain	Range 0 (no pain) to 10 (maximum pain)	week 1-week 7 post procedure, 3 months, 6 months