Study of a New Circular Anal Dilator
Condition: Hemorrhoids
MeSH terms: Hemorrhoids
Study type: Interventional

Summary: 
      The purpose of this research study is to test the effectiveness of a new anoscope used while
      performing a traditional hemorrhoidectomy.
    

Detailed description: 
      Historically, surgical hemorrhoidectomy has been effective at eliminating hemorrhoids but is
      associated with high complication rates and post-operative disability. The problems that are
      most common immediately after hemorrhoidectomy are severe pain, urinary retention, bleeding
      and fecal impaction. The most dreaded long term complications are anal stricture and fecal
      incontinence.

      Stricture or narrowing of the anal canal after hemorrhoidectomy is the direct result of
      excising too much anoderm and mucosa. Even in circumferential prolapsed hemorrhoids, a
      standard three quadrant hemorrhoidectomy is all that is necessary. Mild anal stricture can be
      treated with a Hegar dilator but severe stricture requires a lateral internal sphincterotomy
      with or without a skin advancement flap. These operations are morbid and results are
      generally poor.

      Anal sensation is partially impaired leading to some degree of incontinence of 50% of
      patients after hemorrhoidectomy. Persistent incontinence results from being over aggressive
      during the hemorrhoidectomy and excising muscle with the hemorrhoid during dissection.

      The majority of these long term complications are solely dependent on surgical technique. The
      majority of hemorrhoidectomies performed today are still performed by non-specialty surgeons.
      They rely on various instruments during the surgery to perform the operation in the anal
      canal with adequate exposure but the most important instrument is the anoscope.

      A variety of anoscopes are currently available, but the standard anoscope used for
      hemorrhoidectomy is the Hill-Ferguson. The Hill-Ferguson is a crescent shaped instrument that
      provides adequate exposure in the anal canal and allows the surgeon to perform a Ferguson
      hemorrhoidectomy, the standard of care for hemorrhoidectomy in this country. During this
      procedure an elliptical excision is begun at the perianal skin to include both external and
      internal hemorrhoids and is ended at the anorectal ring. A full thickness of mucosa and
      submucosa is excised and the surgeon should dissect superficial to the internal sphincter
      muscle. The strip of this excision should be no wider than 1.5 cm but currently nothing
      prevents the surgeon from exceeding this limitation or from taking muscle with the excision.
      The widely accepted Hill-Ferguson Anoscopes provide vast exposure but do not set any
      boundaries for the surgeon when performing this operation.

      Over the last several decades few modifications have been introduced to alter the contour of
      the anoscope in an attempt to reduce the complications of post-operative stricture and
      incontinence. Furthermore, the current anoscopes lack the ability to outline a precise
      excision path for the infrequent anorectal surgeon or for the non-specialist in the
      community.

      Recently, Ethicon surgical has developed an anoscope that outlines the precise path for
      hemorrhoid excision without the possibility of excision greater than 1.5 cm of anoderm with
      each excision. This instrument allows the standard of care Ferguson hemorrhoidectomy to be
      performed and does not alter the steps of the operation. The presumed advantages are the
      ability of the instrument to guide an accurate dissection and also to decrease the overall
      time it takes to perform hemorrhoidectomy. It has been tested in several porcine models.
      Operative times, tissue excised, and evaluation of the suture line were addressed during
      these trials and there were no instances of bleeding or excessive tissue excision.

      The study design will be a prospective feasibility trial. Patients who are scheduled for
      operative excisional hemorrhoidectomy will undergo their planned procedure according to the
      standard of care which is a Ferguson hemorrhoidectomy. The only new variable introduced will
      be the application of a new anoscope to facilitate the dissection. Other than the new
      anoscope all pre-operative, intra-operative, and post-operative guidelines consistent with
      the current standards will be followed. The primary goal is to confirm that the new anoscope
      permits standard hemorrhoidectomy, and to obtain phase I data confirming that this novel
      anoscope is safe and efficacious in the performance of a Ferguson hemorrhoidectomy.
    

Intervention name(s): Circular Anal Dilator for Transanal Hemorrhoidectomy
Intervention type(s): Device
Intervention description(s): The Circular Anal Dilator for Transanal Hemorrhoidectomy (product #CAD01) allows the standard of care Ferguson hemorrhoidectomy to be performed and does not alter the steps of the operation. The presumed advantages are the ability of the dilator to guide an accurate dissection and also to decrease the overall time it takes to perform hemorrhoidectomy.
Other intervention name(s): Chemo 2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Hemorrhoids