Latex vs Non-Latex Banding for Hemorrhoids

(NO-Tex Trial)

Overseen By Adam Truong, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Huntington Memorial Hospital

Must not be taking: Anticoagulants

Disqualifiers: Latex allergy, Pregnancy, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate

164 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using anticoagulants (blood thinners), you would not be eligible to participate.

What data supports the effectiveness of the treatment for hemorrhoids?

Research shows that rubber band ligation, a method similar to both latex and non-latex banding, is effective in treating hemorrhoids. Studies indicate that it improves symptoms in a significant number of patients and is considered a good option for early and some advanced cases of hemorrhoidal disease. ^{1 2 3 4 5}

Is latex banding safe for humans?

Latex can cause allergic reactions in some people, ranging from mild skin irritation to severe reactions like anaphylaxis (a serious allergic reaction). Non-latex alternatives are generally safer for those with latex allergies. ^{6 7 8 9 10}

How does the Latex vs Non-Latex Banding treatment for hemorrhoids differ from other treatments?

This treatment is unique because it compares the use of latex and non-latex bands for hemorrhoid banding, which is a method that involves placing a tight band around the base of a hemorrhoid to cut off its blood supply, causing it to shrink and fall off. The study explores the potential differences in effectiveness and safety between latex and non-latex materials, which is important for patients with latex allergies. ^{6 11 12 13 14}

What is the purpose of this trial?

This study will involve the recruitment of adult patients with hemorrhoids for whom rubber band ligation is the recommended treatment. Patients will be randomized to receive banding with a latex band or non-latex band. Our goal will be to measure the performance of latex bands vs non-latex bands.

Research Team

Adam Truong, MD

Principal Investigator

Huntington Health

Eligibility Criteria

This trial is for adults with hemorrhoids recommended to undergo rubber band ligation, a common treatment. Specific eligibility criteria are not provided, so generally healthy individuals with this condition may qualify.

Inclusion Criteria

I am getting treatment for painful internal hemorrhoids.

Exclusion Criteria

I am currently on immunosuppressive therapy.

I am currently using blood thinners.

Known latex allergy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive hemorrhoid banding with either latex or non-latex bands

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for banding-related adverse events including pain, bleeding, and complications

3 weeks

Extended Follow-up

Participants are monitored for hemorrhoidal bleeding and prolapse symptoms following ligation

2-4 months

Treatment Details

Interventions

• Latex Band
• Non-Latex Band

Trial Overview The study compares the effectiveness of two types of bands used in hemorrhoid treatment: one made from latex and another made from non-latex material. Patients will be randomly assigned to receive one or the other.

Participant Groups

Group I: Non-latex band Experimental Treatment 1 Intervention

Non-latex bands will be placed on hemorrhoids during banding

Group II: Latex band Active Control 1 Intervention

latex bands will be placed on hemorrhoids during banding

Latex Band is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Rubber Band Ligation for:

• Internal Hemorrhoids

Approved in United States as Hemorrhoid Banding for:

• Internal Hemorrhoids

Approved in Canada as Latex Band Ligation for:

• Internal Hemorrhoids

Who Is Running the Clinical Trial?

Huntington Memorial Hospital

Lead Sponsor

Trials

7

Recruited

2,000+

Findings from Research

Rubber band ligation of hemorrhoids results in significantly higher post-treatment pain and discomfort compared to radiofrequency coagulation, with patients experiencing more severe pain and rectal tenesmus after the procedure.

While radiofrequency coagulation offers less pain and allows patients to return to work sooner (2 days vs. 5 days), it has a higher recurrence rate of hemorrhoids, indicating a trade-off between comfort and long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency coagulation versus rubber band ligation in early hemorrhoids: pain versus gain. Gupta, PJ.[2018]

Rubber band ligation was found to be more effective than infrared coagulation for treating bleeding internal hemorrhoids, with 22 out of 23 patients showing improvement after one month compared to 16 out of 25 patients in the infrared group.

Despite some complications associated with rubber band ligation, such as thrombosed hemorrhoids and delayed bleeding, the discomfort levels during and after the procedure were similar for both treatments, indicating that rubber band ligation is a viable option for effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single session treatment for bleeding hemorrhoids. Weinstein, SJ., Rypins, EB., Houck, J., et al.[2009]

The rubber band ligation technique for treating hemorrhoidal disease was evaluated over four years with 60 patients, showing it to be an effective non-surgical option for early-stage hemorrhoids.

The technique was also successfully applied in select cases of advanced hemorrhoidal disease and intra-anal mucosal prolapse, indicating its versatility beyond traditional uses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rubber band ligation of hemorrhoids. A four-year experience]. Basile, M., Pierfelice, A., Quitadamo, S., et al.[2006]

Modified rubber band ligation (MRBL) significantly reduces post-operative pain, bleeding, and urine retention compared to Milligan-Morgan haemorrhoidectomy (MMH) in patients with grade III internal hemorrhoids, based on a study of 120 patients.

Both MRBL and MMH have similar post-operative recurrence rates, but MRBL maintains resting anal pressure (RAP) levels, while MMH leads to a significant increase in RAP after surgery, making MRBL a preferable option for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of modified rubber band ligation in the treatment of grade III internal hemorrhoids. Jin, L., Yang, H., Qin, K., et al.[2021]

Rubber band ligation, specifically the Barron technique, is an effective treatment for hemorrhoids, achieving a 74% success rate in grade 3 cases, while also being effective for grades 1 and 2.

For symptomatic hemorrhoids of grades 1 and 2 with a short clinical history, initial treatment with a high-fiber diet and increased water intake is recommended before considering ligation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rubber-band ligation for hemorrhoids in a colorectal unit. A prospective study. Bernal, JC., Enguix, M., López García, J., et al.[2019]

In a study of 20 patients with contact urticaria from rubber gloves, all participants tested positive to at least two latex glove eluates, confirming their latex allergy.

Non-latex gloves were found to be safe alternatives, as all patients had negative reactions to them, while hypoallergenic latex gloves caused a reaction in only one patient, suggesting they may not be suitable for everyone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prick and use tests with 6 glove brands in patients with immediate allergy to rubber proteins. Lahti, A., Turjanmaa, K.[2019]

Natural latex from the rubber tree can cause allergic reactions, ranging from mild skin irritation to severe anaphylaxis, particularly in certain high-risk groups.

Individuals with spina bifida, congenital urogenital anomalies, healthcare workers, and those in the rubber industry are most susceptible to these latex allergies, highlighting the need for healthcare workers to minimize patient exposure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latex allergy in children. Shaer, C., Slater, JE.[2019]

Allergic reactions to natural rubber latex (NRL) in dental practice are on the rise, affecting both dental professionals and patients, highlighting the need for awareness and preparedness.

A case report described a patient experiencing hypersensitivity symptoms shortly after the placement of a rubber dam, which was managed successfully with oxygen and intravenous hydrocortisone, indicating the importance of prompt treatment for allergic reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergic reaction after rubber dam placement. de Andrade, ED., Ranali, J., Volpato, MC., et al.[2019]

A 13-year-old boy developed severe latex allergy symptoms after prolonged exposure to orthodontic rubber bands, highlighting the increasing prevalence of latex hypersensitivity, especially in individuals with cumulative exposure.

While sublingual immunotherapy showed efficacy in treating his latex allergy, the safest approach remains complete avoidance of latex products, emphasizing the need for public health measures to promote synthetic alternatives in environments like airports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Failure of sublingual immunotherapy to treat latex allergy. A report of a case]. Morfin Maciel, BM., Castillo Morfin, BM.[2022]

There has been a significant increase in allergic reactions to natural rubber latex (NRL), particularly in medical procedures involving children with spina bifida, highlighting the need for awareness among healthcare workers and patients.

The report emphasizes the importance of diagnosing NRL allergies and suggests strategies to reduce occupational exposure for healthcare workers, which may help minimize allergic reactions associated with frequent glove use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dental team and latex hypersensitivity. ADA Council on Scientific Affairs. [2019]

In a study involving 8 patients allergic to 2-hydroxyethyl methacrylate (2-HEMA), two types of neoprene gloves provided the best protection against allergic reactions from dental bonding products.

The research highlights the importance of selecting appropriate non-latex gloves in dentistry to prevent allergic contact dermatitis and urticaria, demonstrating that some gloves offer significantly better protection than others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo testing of the protection provided by non-latex gloves against a 2-hydroxyethyl methacrylate-containing acetone-based dentin-bonding product. Andersson, T., Bruze, M., Gruvberger, B., et al.[2019]

Allergard latex-free surgical gloves are compromised by contact with polymethyl methacrylate (PMMA), which can pose safety risks during surgeries involving bone-cement, such as total knee arthroplasty.

In contrast, Biogel Neotech and Duraprene latex-free gloves do not degrade when in contact with PMMA, making them safer alternatives for surgical procedures that require the use of bone-cement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of polymethyl methacrylate on latex-free surgical gloves. Edwards, TB., Habetz, S., D'ambrosia, RD.[2004]

Preloaded haemorrhoid banding devices generate significantly lower load compared to manually loaded devices, with a mean difference of -11.9 grams, which could impact their effectiveness in treatment.

The load from preloaded bands decreases over time, losing approximately 3.7 grams for each month closer to the expiry date, likely due to being stored in a stretched state, highlighting the importance of considering device storage conditions in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inferior load generated by preloaded versus manually loaded haemorrhoid banding devices: the effect of 'creep relaxation'. Moloney, J., Hiscock, R., Nguyen, MH.[2020]

The study tested the cytotoxicity of five different orthodontic separating elastics (four latex and one non-latex) using human cell cultures, finding that the non-latex Masel elastic caused significantly less cell lysis compared to the latex options.

Despite some differences in cytotoxicity, all elastics were deemed clinically biocompatible, highlighting the importance of using materials that minimize allergic reactions and cytotoxic effects in orthodontic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the cytotoxicity of latex and non-latex orthodontic separating elastics. dos Santos, RL., Pithon, MM., Martins, FO., et al.[2010]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Radiofrequency coagulation versus rubber band ligation in early hemorrhoids: pain versus gain. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Single session treatment for bleeding hemorrhoids. [2009]

3. Italy pubmed.ncbi.nlm.nih.gov

[Rubber band ligation of hemorrhoids. A four-year experience]. [2006]

4. China pubmed.ncbi.nlm.nih.gov

Efficacy of modified rubber band ligation in the treatment of grade III internal hemorrhoids. [2021]

5. Spain pubmed.ncbi.nlm.nih.gov

Rubber-band ligation for hemorrhoids in a colorectal unit. A prospective study. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Prick and use tests with 6 glove brands in patients with immediate allergy to rubber proteins. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Latex allergy in children. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Allergic reaction after rubber dam placement. [2019]

9. Mexico pubmed.ncbi.nlm.nih.gov

[Failure of sublingual immunotherapy to treat latex allergy. A report of a case]. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The dental team and latex hypersensitivity. ADA Council on Scientific Affairs. [2019]

11. Sweden pubmed.ncbi.nlm.nih.gov

In vivo testing of the protection provided by non-latex gloves against a 2-hydroxyethyl methacrylate-containing acetone-based dentin-bonding product. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

The effect of polymethyl methacrylate on latex-free surgical gloves. [2004]

13. Australia pubmed.ncbi.nlm.nih.gov

Inferior load generated by preloaded versus manually loaded haemorrhoid banding devices: the effect of 'creep relaxation'. [2020]

14. England pubmed.ncbi.nlm.nih.gov

Evaluation of the cytotoxicity of latex and non-latex orthodontic separating elastics. [2010]