Latex vs Non-Latex Banding for Hemorrhoids
(NO-Tex Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Huntington Memorial Hospital
Must not be taking: Anticoagulants
Disqualifiers: Latex allergy, Pregnancy, Bleeding disorder, others
No Placebo Group
Trial Summary
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.
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.12345
Is latex banding safe for humans?
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.611121314
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
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Trial 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 (Device)
- Non-Latex Band (Device)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Non-latex bandExperimental Treatment1 Intervention
Non-latex bands will be placed on hemorrhoids during banding
Group II: Latex bandActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Huntington Memorial HospitalPasadena, CA
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Who Is Running the Clinical Trial?
Huntington Memorial HospitalLead Sponsor
References
Radiofrequency coagulation versus rubber band ligation in early hemorrhoids: pain versus gain. [2018]Band ligation of internal hemorrhoids is a well-established and accepted office procedure. However, there are several reports focusing on problems associated with this technique, which is perceived by many to be risk-free. This randomized study is aimed to compare radiofrequency coagulation and rubber band ligation of hemorrhoids on the parameters of effectiveness and comfort.
Single session treatment for bleeding hemorrhoids. [2009]Fifty consecutive outpatients with bleeding internal hemorrhoids were prospectively treated with a single application of rubber band ligation or infrared coagulation. Complete follow-up observation was obtained in 48 patients (23 underwent rubber band ligation and 25 underwent infrared coagulation). At one month after treatment, 22 patients who underwent rubber band ligation and 16 who underwent infrared coagulation, were symptomatically improved (p less than 0.05). At six months, 15 patients who had undergone rubber band ligation and ten who had infrared coagulation treatment, remained improved (p less than 0.05). There was no statistical difference in the discomfort experienced by either group during or after the procedure as determined by a self-assessment scale. Two patients who underwent rubber band ligation experienced complications--a thrombosed external hemorrhoid developed in one patient and another had delayed rectal bleeding. Although associated with occasional complications after treatment, rubber band ligation is more effective than in infrared coagulation for single session treatment of bleeding internal hemorrhoids.
[Rubber band ligation of hemorrhoids. A four-year experience]. [2006]The non-surgical approach to hemorrhoidal disease was considered, particularly in relation to the rubber band ligation technique. On the basis of a four-year experience collected on 60 treated patients among 75 observed, cases, indications, results and advantages of the method were outlined. Besides the classic method's applications, two cases were presented in which the technique was applied on the grounds of non typical indications. From the final results the rubber band method represents a good therapeutic option for early degrees of hemorrhoidal disease. Moreover, on the basis of the author's experience, this method is also suitable in appropriately selected cases of advanced hemorrhoidal disease intra-anal mucosal prolapse.
Efficacy of modified rubber band ligation in the treatment of grade III internal hemorrhoids. [2021]Traditional rubber band ligation can improve the symptoms of hemorrhoids, the techniques used vary among centers and the degree of hemorrhoids may also affect the therapeutic efficacy and postoperative outcome, especially for patients with grade III hemorrhoids (hemorrhoid prolapses). This study aimed to investigate the clinical efficacy of modified rubber band ligation (MRBL) in the treatment of grade III internal hemorrhoids.
Rubber-band ligation for hemorrhoids in a colorectal unit. A prospective study. [2019]Nowadays the rubber band ligation technique is one of the most worldwide used and effective treatment of the hemorrhoidal disease.
Prick and use tests with 6 glove brands in patients with immediate allergy to rubber proteins. [2019]20 patients with contact urticaria from rubber gloves were prick tested using eluates from 4 latex (Triflex, Ansell Gammex, Exona, Armi) and 2 non-latex (Tactylon, Elastyren) glove brands. All patients showed a positive prick test reaction to at least 2 latex glove eluates. A hypoallergenic glove (Ansell Gammex) gave a positive prick test reaction in 1 patient, but non-latex gloves were negative in all cases. All patients showed a positive result in the use test with a latex surgical glove (Triflex), whereas none did with a non-latex glove (Tactylon). Non-latex gloves and, in some cases, also hypoallergenic latex gloves, are a good alternative to rubber gloves for patients with immediate latex allergy.
Latex allergy in children. [2019]Natural latex, a product of the tropical rubber tree, Hevea brasiliensis, has been shown to cause allergic reactions in an increasing number of individuals. Severity of reaction has ranged from mild contact dermatitis to anaphylaxis. Individuals with spina bifida, congenital urogenital anomalies, health care workers, and those employed in the rubber industry are at highest risk for immediate hypersensitivity to latex. Health care workers should be aware of this high risk to minimize exposure of patients.
Allergic reaction after rubber dam placement. [2019]In the last few years allergic reactions to natural rubber latex (NRL) have increased in dental practice affecting both the dental team and patients. Some case reports discuss the potential risks of hypersensitivity to NRL products. An adverse patient reaction after dental rubber dam placement is reported. About 1 min after the isolation of the tooth with a rubber dam the patient presented signs and symptoms of hypersensitivity. Oxygen and intravenous hydrocortisone were administered and the patient kept under observation. After 2 h she had stable vital signs and no more allergics symptoms. It is unclear whether components of the NRL dam or the cornstarch powder incorporated with the rubber dam was responsible for the allergic reaction. Dentists must be aware of the health problem and be prepared for an adequate management in dental practice.
[Failure of sublingual immunotherapy to treat latex allergy. A report of a case]. [2022]Natural rubber latex has been in widespread use for over a century. Reports of immediate hypersensitivity to latex have increased dramatically since the first case was reported in 1979, specially in persons with cumulative latex exposure. A 13 year old male was referred to our office. He had been wearing orthodontic rubber bands for two years. The previous year he started having itchy, red and watery eyes, with sneezing and runny nose when he was exposed to rubber products. Then he developed oral edema and lip ulcers. Finally, he experienced cough, wheezing, chest tightness and dyspnea. The patient had no history of undergoing surgery, and his mother denied pacifier use. He had no history of fruit and vegetables allergy. Physical examination revealed conjunctival hyperemia, with fine papillary response in the upper tarsal plate, hyaline rhinorrhea, turbinate hypertrophy and perioral ulcers. Skin prick test were positive for latex and Quercus albus. Patch test with latex glove was negative, but positive with rubber tourniquet. Total IgE was 365 UI/mL. Latex-specific IgE testing confirmed the diagnosis. Spirometric values were normal. He started rush sublingual immunotherapy with latex extract. When he had finished, he traveled abroad. At immigration the inspectors examined him with latex gloves. Immediately he developed anaphylaxis, needing urgent medical attention. Although the efficacy and safety of sublingual immunotherapy for latex allergy has been demonstrated, the most effective strategy is complete avoidance of latex-containing products. World Public Health Services must promote the use of synthetic elastomer gloves in airports worldwide.
The dental team and latex hypersensitivity. ADA Council on Scientific Affairs. [2019]In the late 1980s, there were notable increases in reports of allergic reactions to natural rubber latex, or NRL, particularly in association with barium enema procedures and medical procedures performed on children with spina bifida. These reports also raised awareness of the growing concern about NRL allergy in both patients and health care workers.
In vivo testing of the protection provided by non-latex gloves against a 2-hydroxyethyl methacrylate-containing acetone-based dentin-bonding product. [2019]In dentistry, allergic contact dermatitis to acrylates and allergic contact urticaria to latex are important occupational hazards. There is a need to identify non-latex gloves which are suitable for dental work but at the same time provide adequate protection against acrylate monomers. In a previous study, a new open-chamber system was used for testing the in vivo protection of 6 different gloves against an acrylate-containing ethanol-based dental adhesive. A nitrile glove gave the best protection among the gloves suitable for dental work. In the present study, the test model was used to investigate the in vivo protection of 7 non-latex gloves against a dental bonding product containing 2-hydroxyethyl methacrylate (2-HEMA) in an acetone/water vehicle. Eight 2-HEMA-allergic patients participated. Two neoprene gloves gave the best protection. The protection of the poorest glove was comparable to that of the positive control (no glove). The study produced in vivo data useful in the implementation of individual preventative measures against contact allergy to acrylates.
The effect of polymethyl methacrylate on latex-free surgical gloves. [2004]In the current medical environment of increased awareness about latex sensitivity, more patients are presenting with known latex allergy. One such patient presented to us for total knee arthroplasty. During this procedure, we noticed holes in our latex-free surgical gloves when polymethyl methacrylate (PMMA) was being handled. Through subsequent testing of different brands of latex-free surgical gloves with various brands of bone-cement, we found that Allergard latex-free surgical gloves are destroyed by contact with PMMA. Biogel Neotech and Duraprene latex-free gloves show no such destruction. These results indicate that Allergard gloves should not be used in procedures in which bone-cement is employed. Biogel Neotech and Duraprene latex-free gloves are an acceptable alternative.
Inferior load generated by preloaded versus manually loaded haemorrhoid banding devices: the effect of 'creep relaxation'. [2020]The efficacy of rubber band ligation of haemorrhoids relies on the load generated on haemorrhoidal tissue by bands as they return to their preformed shape after being deployed. 'Preloaded' haemorrhoid banding devices are widely available, but the effect of the resultant prolonged stretch on bands while stored in this manner has never been examined by comparing these to manually loaded devices, which are stretch immediately prior to being deployed. A difference could have clinical relevance, potentially resulting in a higher rate of clinical failure. The present study aimed to investigate any difference in load generated by preloaded versus manually loaded devices.
Evaluation of the cytotoxicity of latex and non-latex orthodontic separating elastics. [2010]To test the hypothesis that a difference in cytotoxicity exists between latex and non-latex orthodontic separating elastics.