Comparative analysis between outcomes of 3 percentage polidocanol sclerotherapy versus Modified Barrons rubber band ligation in the management of grade 2 internal hemorrhoidal disease : A non inferiority randomised control trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 332
- Locations
- 1
- Primary Endpoint
- To assess the patient related outcomes blood loss pain prolapse itching soiling of 3 percentage polidocanol Sclerotherapy as compared to Modified Barrons Rubber Band Ligation in treatment of grade 2 internal haemorrhoidal disease using Patient Reported Outcome Measures Haemorrhoidal Impact and Satisfaction Score PROM HISS questionnaire
Study Overview
Brief Summary
The study will be conducted in the Department of General Surgery AIIMS Patna and will include patients with Grade 2 Internal Hemorrhoidal Disease who have undergone at least one month of conservative management including dietary and lifestyle modifications along with medical management using Micronised Purified Flavonoid Fraction and have not experienced symptom relief Eligible patients will be randomized into two parallel groups Group A receiving 3 percentage Polidocanol Sclerotherapy and Group B undergoing Modified Barrons Rubber Band Ligation with an allocation ratio of 1 to 1 Patients who refuse randomization will be allowed to choose their preferred treatment modality The Sclerotherapy group will receive 4 ml of 3 percentage Polidocanol foam prepared using the Modified Tessari technique and injected via a Kelly proctoscope in the Jackknife position with a maximum dose of 20 ml per session treating multiple nodules if necessary The RBL group will undergo ligation in the Jackknife position using a Kelly proctoscope and a reusable metal ligation device with suction applying two rubber bands per hemorrhoidal pedicle if required Patient related outcomes will be assessed using the Patient Reported Outcome Measure Hemorrhoidal Impact and Satisfaction Score PROM HISS questionnaire which evaluates hemorrhoidal symptoms impact on daily activities and satisfaction with treatment Follow up visits will be conducted at 1 week 6 weeks and 3 months with potential retreatment at 6 weeks if necessary Data will be analyzed on both an intention to treat and per protocol basis with the total study duration expected to be between 1 to 1 year 6 months
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age 18 years or older with grade 2 hemorrhoidal disease giving consent for participation Refractory to conservative management given for at least 1 month.
Exclusion Criteria
- •Grade 1 3 and 4 hemorrhoidal disease Associated complications like strangulation or thrombosis Patients with external hemorrhoids Associated perianal fissure or fistula Patients who have undergone treatment for hemorrhoidal disease within last 12 months regardless of the type of treatment Patients with Inflammatory Bowel Disease Patients with coagulopathies arising from any cause or on anti-coagulation therapy Immunocompromised individuals Pregnant females.
Outcomes
Primary Outcomes
To assess the patient related outcomes blood loss pain prolapse itching soiling of 3 percentage polidocanol Sclerotherapy as compared to Modified Barrons Rubber Band Ligation in treatment of grade 2 internal haemorrhoidal disease using Patient Reported Outcome Measures Haemorrhoidal Impact and Satisfaction Score PROM HISS questionnaire
Time Frame: day 0 | 1 week | 6 weeks | 3 months
Secondary Outcomes
- To assess the complication rate of 3 percentage polidocanol Sclerotherapy as compared to Modified Barrons Rubber Band Ligation in treatment of grade 2 internal haemorrhoidal disease(6 weeks)
- To assess the recurrence rate of 3 percentage polidocanol Sclerotherapy as compared to Modified Barrons Rubber Band Ligation in treatment of grade 2 internal haemorrhoidal disease where recurrence means subjective return of symptoms as told by patient(3 months)
Investigators
Dr Swarnima Shubhadarshini
all india institute of medical sciences patna