Hemorrhoids

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Hemorrhoids

General Purpose: 

Hemorrhoids, also known as piles, are veins in the anus and lower rectum area that become swollen and inflamed. They can occur as a result of straining during bowel movements, increased pressure during pregnancy, chronic constipation, obesity, and anal intercourse.

They are incredibly common – nearly half of all people will experience hemorrhoids by the age of 50. They can occur internally or externally, and symptoms include pain, burning, itching, bleeding, swelling, anal lumps, and leakage of fecal matter.

Complications rarely occur but when they do, they include anemia (decreased red blood cells and resulting fatigue), and tissue death (gangrene).

Due to their extreme prevalence, researchers continue to explore more effective ways of treating hemorrhoids, including refining both surgical and non-surgical methods of treatment. Researchers are also working to identify better ways to prevent the development of hemorrhoids at high-risk individuals.

What Will Hemorrhoid Clinical Trials Be Like?

The types of tests and assessments used in clinical trials for hemorrhoids will ultimately depend on the specific nature of the study. Provided below is a list of frequent procedures and tests that may be incorporated into clinical trials:

  • Physical exam, including a digital rectal exam (DRE), during which a doctor inserts a gloved, lubricated finger into the rectum to feel for abnormalities, as well as a visual inspection of the anus and rectum.
  • Detailed medical history
  • Blood tests to look for signs of infection
  • Sigmoidoscopy, which is a procedure during which the rectum and lower colon are examined using a thin, flexible tube with a tiny light and camera on the end.
  • Colonoscopy, which is a procedure similar to a sigmoidoscopy, however it is used to view the entire colon. Sigmoidoscopy and colonoscopy may be used for individuals with hemorrhoids to rule out the presence of other digestive system diseases, including cancer.
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Pain and quality of life assessments, as well as diet, exercise and/or medication diaries, may also be required in some studies, depending on the research question being studied.

Typical Hemorrhoid Clinical Trial Protocol:

Specific examples of clinical trials for hemorrhoids might include the following:

  • A randomized clinical trial to compare the effectiveness of two different treatments for bleeding internal hemorrhoids. In such a trial, half of the patients would be randomly assigned to receive treatment with band ligation (placing rubber bands around the hemorrhoids) or electrocoagulation (using electricity to burn the hemorrhoids).
  • A randomized clinical trial to determine if a newly-developed pain medication is more effective than standard post-operative pain control methods when administered to patients who undergo surgery to treat their hemorrhoids. In this study, half of the patients would receive the new drug while the other half would receive a placebo.
  • An interventional study to determine if a dietary and behavioral lifestyle intervention is more effective at promoting the healing of pregnancy-related hemorrhoids following delivery than standard post-natal care.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug or intervention, compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone (such as in the second example provided above). In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your history of hemorrhoids
  • Any underlying illnesses you have
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your history of treatment for hemorrhoids

Suggested Search Terms:

Once you are ready to begin your search for hemorrhoid clinical trials, the following terms may be of use when combined with “hemorrhoids”: “prevention,” “management,” “treatment,” “diet,” “exercise,” “disease,” “elderly,” “side effects,” “medication,” “surgery,” “pregnancy,” “childbirth,” and “diagnosis.”

 

 

Current Search Term:

“Hemorrhoids”

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Multi-Drug Analgesia vs. Standard Solution for Anal Surgery


Conditions:   Hemorrhoids;   Fissure in Ano;   Fistula;Rectal
Interventions:   Drug: Multi-drug local anesthetics (Combination);   Drug: Standard local anesthetics (Combination)
Sponsor:   Columbia University
Not yet recruiting - verified April 2017


Validation of Hemorrhoidal Bleeding Score


Condition:   Hemorrhoid Bleeding
Intervention:  
Sponsor:   Groupe Hospitalier Paris Saint Joseph
Recruiting - verified February 2017


Effect of Topical Trimebutine on Pain After Hemorrhoidectomy


Condition:   Hemorrhoids
Interventions:   Drug: Trimebutine;   Procedure: Hemorrhoidectomy
Sponsor:   Mansoura University
Not yet recruiting - verified January 2017


Efficacy and Safety of CLIFE1 Gel in Benign Anorectal Surgery


Conditions:   Fissure;Anal;   Fistula;Rectal;   Hemorrhoids
Interventions:   Drug: anesthesics plus antiinflammatory, CLIFE1;   Drug: local anesthesics, CLIFE2
Sponsor:   Hospital de Viladecans
Completed - verified November 2016


Validation of Sodergren Score for Haemorrhoids in Malaysia


Condition:   Hemorrhoids
Intervention:  
Sponsor:   University of Malaya
Recruiting - verified January 2017


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


Conditions:   Hemorrhoids;   Bleeding;   Pain
Interventions:   Procedure: Rubber Band Ligation;   Procedure: Hypertonic Saline Infusion
Sponsor:   American University of Beirut Medical Center
Not yet recruiting - verified May 2016


HET Bipolar System: Validation of Outpatient Hemorrhoid Treatment


Condition:   Hemorrhoids
Intervention:   Procedure: HET Application
Sponsors:   University of Illinois at Chicago;   Medtronic
Active, not recruiting - verified May 2016


Calcium Dobesilate vs Flavonoids for the Treatment of Early Hemorrhoidal Disease


Condition:   Hemorrhoids
Interventions:   Drug: Flavonoids;   Drug: CDobi
Sponsor:   Services Hospital, Lahore
Recruiting - verified January 2017


Prospective Randomized Trial About THD Versus Ligasure Hemorrhoidectomy for Grade III and IV Hemorrhoids


Condition:   Hemorrhoids
Interventions:   Device: Transanal hemorrhoidal dearterialization + mucopexy (THD).;   Procedure: Ligasure™ hemorrhoidectomy;   Device: THD anoscope and doppler;   Device: Ligasure Vessel Sealing
Sponsor:   Hospital Universitari de Bellvitge
Recruiting - verified March 2017


Posthemorrhoidectomy Pain Management With Electronic Bidet or Sitz Bath


Condition:   Hemorrhoid
Interventions:   Other: Electronic bidet;   Other: Sitz bath
Sponsors:   Seoul National University Hospital;   Daehang Hospital;   Coway Co
Enrolling by invitation - verified October 2016


Topical Anesthesia Versus Placebo to Decrease Pain in Rubber Band Ligation for Treatment of Internal Hemorrhoids


Conditions:   Hemorrhoids;   Pain
Interventions:   Drug: Topical 2,5% lidocaine + 2,5% prilocaine gel;   Drug: Placebo
Sponsor:   Pontificia Universidad Catolica de Chile
Completed - verified August 2016


Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy


Condition:   Hemorrhoid
Interventions:   Drug: Exparel;   Drug: Bupivacaine HCl with Epinephrine;   Drug: Normal Saline
Sponsor:   St. Luke's-Roosevelt Hospital Center
Terminated - verified January 2017


THD Versus Open Haemorrhoidectomy


Condition:   Hemorrhoids
Interventions:   Procedure: Transanal Haemorrhoidal Dearterialization;   Procedure: Open Haemorrhoidectomy
Sponsor:   Holbaek Sygehus
Active, not recruiting - verified December 2016


Safety and Efficacy of the Addition of Morphine Chloride to a Low Dose of Bupivacaine as Intradural Anaesthetic for the Removal Surgery of the Hemorrhoids


Condition:   Surgical Remove of Hemorrhoids
Interventions:   Drug: Bupivacaine low dose;   Drug: Bupivacaine standard dose;   Drug: Morphine Chloride
Sponsors:   Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias;   Spanish Agency of Medicines;   Spanish Health Ministry
Completed - verified August 2014


Perineal Self-Acupressure


Conditions:   Chronic Constipation;   Constipation;   Hemorrhoids
Interventions:   Behavioral: Perineal Self-Acupressure;   Behavioral: Educational Control
Sponsors:   University of California, Los Angeles;   Yale University
Completed - verified November 2016


Safety and Efficacy Study of Anucort HC TM 25mg Rectal Suppositories to Treat Symptomatic Internal Hemorrhoids


Condition:   Internal Hemorrhoids
Interventions:   Drug: Anucort-HC, 25 Mg Rectal Suppository;   Drug: Placebo suppository
Sponsor:   G & W Laboratories Inc.
Completed - verified November 2016


Safety and Efficacy Study of HET Bipolar System for Treatment of Stage I and Stage II Hemorrhoids


Condition:   Hemorrhoids, Internal
Intervention:   Device: HET Bipolar System
Sponsor:   Medtronic - MITG
Completed - verified November 2016


Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy


Condition:   Hemorrhoids
Interventions:   Procedure: Hemorrhoidal artery ligation with rectoanal repair;   Procedure: Stapled hemorrhoidopexy
Sponsor:   Cantonal Hospital of St. Gallen
Recruiting - verified June 2016


Is Doppler Necessary in Haemorrhoidal Artery Ligation Operation?


Conditions:   Piles;   Bleeding
Intervention:   Procedure: HALO
Sponsor:   Poole Hospital NHS Foundation Trust
Terminated - verified April 2017

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