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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02851940
Enrollment
0
Registered
2016-08-02
Start date
2016-09-30
Completion date
2018-01-31
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhoids, Bleeding, Pain

Keywords

Pain, Bleeding, Hemorrhoids, Band Ligation, hypertonic saline sclerotherapy

Brief 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

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.

Interventions

Anoscopic rubber band ligation by bedside with patient in the jack-knife position (equipment: anoscope, rubber band applicator)

Endoscopic retroflexed 3 ml injection of 20% hypertonic saline 1cm above the dentate line (equipment: Flex sig, injection needle, 20% saline)

Sponsors

American University of Beirut Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Composite Pain ScoreDays 0 after procedureRange 0 (no pain) to 10 (maximum pain)

Secondary

MeasureTime frameDescription
BleedingDays 1 to 7 after the procedureIf any bleeding is noticed upon defecation
Pain Medication UsageDays 1 to 7 after the procedure
Painweek 1-week 7 post procedure, 3 months, 6 monthsRange 0 (no pain) to 10 (maximum pain)

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026