<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03283540</url>
  </required_header>
  <id_info>
    <org_study_id>CASE6217</org_study_id>
    <nct_id>NCT03283540</nct_id>
  </id_info>
  <brief_title>Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence</brief_title>
  <official_title>The Short Term Implications of Transanal Total Mesorectal Excision (TaTME) for Rectal Cancer on Anal Physiology and Fecal Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Low Anterior Resection (LAR) surgery can be done using various techniques. The traditional&#xD;
      technique for performing the surgery is through one or multiple incision(s) in the muscular&#xD;
      wall of the abdomen. This will allow the surgeon to gain access to inside the belly&#xD;
      (Abdominal cavity). The surgeon will start from above and go down until reaching the rectum&#xD;
      located low in the pelvis. The surgeon will then cut out the rectum along with some of the&#xD;
      tissue surrounding it and reconnect the bowel.&#xD;
&#xD;
      An alternative new approach to perform Low Anterior Resection is called the Trans-anal&#xD;
      approach. In this technique, a tube containing special surgical tools is introduced through&#xD;
      the anus (back passage), while the patient is asleep. These tools are used to free the rectum&#xD;
      up from its surroundings so that it can be removed.&#xD;
&#xD;
      Taking out the rectum via the opening of the anus (Trans-anal) is a relatively new surgical&#xD;
      approach. This new technique enables the surgeon to better see deep in the pelvis which makes&#xD;
      it easier to remove the rectum and its surrounding outer tissues while protecting other&#xD;
      important nerves and organs located in the pelvis. However, it also involves inserting a tube&#xD;
      through the opening of the anus to perform the rectal dissection. The alternative traditional&#xD;
      way of doing the operation does not involve inserting such a tube because the access to the&#xD;
      pelvis and rectum is gained from above through incision(s) in the abdominal wall.&#xD;
&#xD;
      The anal sphincter is the medical name for the muscle layers surrounding the opening of the&#xD;
      anus. The anal sphincter functions as a seal that can be opened to discharge body waste and&#xD;
      allow the passage of stool. A damage to the anal sphincter can result in inability to fully&#xD;
      control bowel movements, causing stool (feces) to leak unexpectedly. Because the Trans-anal&#xD;
      approach involves inserting a tube through the opening of the anus for the duration of the&#xD;
      surgery, this can lead to a certain degree of stretch and damage to the anal sphincter&#xD;
      muscles.&#xD;
&#xD;
      The main aim of this study is to compare the effect of the these two possible approaches to&#xD;
      perform &quot;Low Anterior Resection&quot; operation on the muscles of the anal sphincter and whether&#xD;
      they are associated with stool seepage from the anus after the operation.&#xD;
&#xD;
      Whether the patient is receiving the traditional or trans-anal approach is not related to the&#xD;
      subject's participation in the study and is decided by the treating surgeon based on medical&#xD;
      and surgical reasoning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective To evaluate effect of TaTME on anal sphincter via anorectal functional&#xD;
      studies and anorectal ultrasound administered post- and preoperatively.&#xD;
&#xD;
      Secondary Objective(s) To evaluate the effect of TaTME on fecal incontinence, quality of&#xD;
      life, and LARS utilizing validated questionnaires administered to patients preoperatively and&#xD;
      during postoperative follow-up.&#xD;
&#xD;
      Study Design This is a prospective two-arm cohort study. The study will include patients&#xD;
      already undergoing the standard-of-care, low anterior resection (LAR) for middle to low&#xD;
      rectal cancers. Low anterior resection of the rectum entails a sharp dissection&#xD;
      circumferentially around the mesorectum in an avascular plane between the visceral and&#xD;
      parietal layers of the endopelvic fascia in what is known as Total Mesorectal Excision (TME).&#xD;
      This dissection can be achieved transanally starting down in the pelvis and going up in what&#xD;
      is known as Transanal Total Mesorectal Excision- (TaTME). It can also be done via an&#xD;
      up-to-down approach beginning high in the abdomen and going low in the pelvis to achieve&#xD;
      dissection around the mesorectum. Access in the latter is achieved via laparoscopic or open&#xD;
      abdominal incisions with minimal anal sphincter dilation. In addition, the level of coloanal&#xD;
      anastomosis performed is potentially higher from the anal sphincter in comparison to TaTME.&#xD;
      TaTME on the other hand, involves introducing a special port (gelpoint path) transanally to&#xD;
      perform the TME dissection. In order to better evaluate the effect of TaTME on anal&#xD;
      sphincter, it is quintessential to include a control group with minimal anal sphincter&#xD;
      manipulation, thus the conventional abdominal (open or laparoscopic) TME group will serve as&#xD;
      a control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>average change in anal resting pressure</measure>
    <time_frame>Up to 6 months post-operation</time_frame>
    <description>anal resting pressure will be estimated by taking measurements prior to operation and at 3-6 months post-operation. The mean change along with its 95% confidence interval will be reported for both groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>maximum squeeze pressure</measure>
    <time_frame>Up to 6 months post-operation</time_frame>
    <description>maximum squeeze pressure will be estimated by taking measurements prior to operation and at 3-6 months post-operation. The mean change along with its 95% confidence interval will be reported for both groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average intra-balloon pressure</measure>
    <time_frame>Up to 6 months post-operation</time_frame>
    <description>Average intra-balloon pressure will be estimated by taking measurements prior to operation and at 3-6 months post-operation. The mean change along with its 95% confidence interval will be reported for both groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Fecal Incontinence Severity Index Score (FISI)</measure>
    <time_frame>From before operation up to 12 weeks after operation</time_frame>
    <description>Self-Reported, 4-question survey describing frequency of incontinence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cleveland Clinic Florida Fecal Incontinence (Wexner) score (CCF-FI)</measure>
    <time_frame>From before operation up to 12 weeks after operation</time_frame>
    <description>Self-Reported, 5-question survey scored 0-4 were higher scores indicate greater incontinence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cleveland Clinic Global Quality of Life score (CGQL)</measure>
    <time_frame>From before operation up to 12 weeks after operation</time_frame>
    <description>Self-Reported, 4-question survey scored 1-10 where higher scores indicate greater quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low Anterior Resection Syndrome score (LARS)</measure>
    <time_frame>From before operation up to 12 weeks after operation</time_frame>
    <description>Self-Reported, 5-question survey with total scores ranging from 0-42 where higher scores indicating less bowel function</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>TaTME</arm_group_label>
    <description>Trans-anal Total Mesorectal Excision (TaTME) is the visualization and dissection of the rectum located deep in the pelvis. In it, a trans-anal port is inserted for the duration of the surgery. Multiple surgical tools are then introduced through the port and the rectum is resected from down-to-up under direct visualization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>abdominal TME</arm_group_label>
    <description>Total Mesorectal Excision involves resecting the rectum along with its surrounding Mesorectal plane. If the anal sphincter is spared, this surgery is named Low Anterior resection (LAR) for rectal cancer. Traditionally, TME dissection in LAR is performed through open or laparoscopic incisions(s) made in the abdominal wall. Mobilization of the splenic flexure along with sigmoid dissection follows. Lastly, the rectum is dissected in accordance with TME principles from above. This &quot;up-to-down&quot; approach is known as abdominal TME.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TaTME</intervention_name>
    <description>Low anterior resection of the rectum entails a sharp dissection circumferentially around the mesorectum in an avascular plane between the visceral and parietal layers of the endopelvic fascia in what is known as Total Mesorectal Excision. This dissection can be achieved transanally starting down in the pelvis and going up in what is known as Transanal Total Mesorectal Excision</description>
    <arm_group_label>TaTME</arm_group_label>
    <other_name>Trans-anal Total Mesorectal Excision</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TME</intervention_name>
    <description>Low anterior resection of the rectum entails a sharp dissection circumferentially around the mesorectum in an avascular plane between the visceral and parietal layers of the endopelvic fascia in what is known as Total Mesorectal Excision. This surgery can also be done via an up-to-down approach beginning high in the abdomen and going low in the pelvis to achieve dissection around the mesorectum.</description>
    <arm_group_label>abdominal TME</arm_group_label>
    <other_name>Total Mesorectal Excision</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Surgical specimen will be evaluated by a pathologist as part of the standard of care for the&#xD;
      quality of resection and TME plane assessment.&#xD;
&#xD;
      Resections will be categorized as follows: R0-all gross disease resected by enblocresection&#xD;
      with margins histologically free of disease; R1-all gross disease resected byenblocresection&#xD;
      with margins histologically positive for disease; and R2-residual gross disease remains&#xD;
      unresected&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Men, women and members of all races and ethnic groups are eligible for this trial. Patients&#xD;
        will be identified prospectively by the treating Co-Investigator surgeon according to the&#xD;
        inclusion/exclusion criteria. The outpatient clinic schedule will be regularly screened&#xD;
        ahead of time to identify potential candidates that fit the enrollment criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have histologically confirmed Rectal Adenocarcinoma.&#xD;
&#xD;
          -  Subjects must have Rectal Adenocarcinoma located up to 10 cm from the anal verge&#xD;
             measured by preoperative MRI, proctoscopy, or digital rectal examination.&#xD;
&#xD;
          -  Subjects must have treated with Transanal total mesorectal excision (TaTME) or&#xD;
             abdominal transanal endoscopic microsurgery (TME) resections.&#xD;
&#xD;
          -  Subjects must be Patients treated with curative intention.&#xD;
&#xD;
          -  Subjects must have the ability to understand and the willingness to sign a written&#xD;
             informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Specific contraindications to laparoscopy.&#xD;
&#xD;
          -  Intestinal obstruction or perforation.&#xD;
&#xD;
          -  Histology other than adenocarcinoma.&#xD;
&#xD;
          -  Subjects with rectal cancer arising in the background of inflammatory bowel disease.&#xD;
&#xD;
          -  Subjects treated through local excision (ie, endoscopic, anorectal, or TEM approach).&#xD;
&#xD;
          -  Subjects with synchronous metastases, except those with resectability criteria for the&#xD;
             rectum.&#xD;
&#xD;
          -  Subjects requiring a multivisceral resection or an abdominoperineal resection.&#xD;
&#xD;
          -  Subjects converted to open technique.&#xD;
&#xD;
          -  Subjects with history of fecal incontinence. Fecal incontinence (FI) will be defined&#xD;
             based on Rome IV Criteria for Colorectal Disorders 31 as the uncontrolled passage of&#xD;
             solid or liquid stool, occurring at least two times in a 4-week period.&#xD;
&#xD;
        Very low rectal cancers can cause a feeling of tenesmus associated with mucus leakage. As a&#xD;
        result, patients will be asked if they had a bowel incontinence problem that dates back to&#xD;
        a year ago (i.e. prior to the manifestation of current rectal cancer symptoms).&#xD;
&#xD;
          -  Subjects with ultra-low rectal cancer where low anterior resection is converted to&#xD;
             abdominoperineal resection intraoperatively due to sphincter involvement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tracy Hull, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland Clinic, Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tracy Hull, MD</last_name>
    <phone>216-445-6063</phone>
    <email>hullt@ccf.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cleveland Clinic, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tracy Hull, MD</last_name>
      <phone>216-445-6063</phone>
      <email>hullt@ccf.org</email>
    </contact>
    <investigator>
      <last_name>Tracy Hull, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Awad Jarrar, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Matthew Kalady, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hermann Kessler, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Conor Delaney, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>David Liska, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Scott Steele, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Luca Stocchi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Valente, DO</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean Ashburn, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Emina Huang, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ian Lavery, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bradley Champagne, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Emre Gorgun, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>August 16, 2023</last_update_submitted>
  <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low Anterior Resection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Fecal Incontinence</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03283540
org study id: CASE6217
nct id: NCT03283540
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Low Anterior Resection (LAR) surgery can be done using various techniques. The traditional
      technique for performing the surgery is through one or multiple incision(s) in the muscular
      wall of the abdomen. This will allow the surgeon to gain access to inside the belly
      (Abdominal cavity). The surgeon will start from above and go down until reaching the rectum
      located low in the pelvis. The surgeon will then cut out the rectum along with some of the
      tissue surrounding it and reconnect the bowel.

      An alternative new approach to perform Low Anterior Resection is called the Trans-anal
      approach. In this technique, a tube containing special surgical tools is introduced through
      the anus (back passage), while the patient is asleep. These tools are used to free the rectum
      up from its surroundings so that it can be removed.

      Taking out the rectum via the opening of the anus (Trans-anal) is a relatively new surgical
      approach. This new technique enables the surgeon to better see deep in the pelvis which makes
      it easier to remove the rectum and its surrounding outer tissues while protecting other
      important nerves and organs located in the pelvis. However, it also involves inserting a tube
      through the opening of the anus to perform the rectal dissection. The alternative traditional
      way of doing the operation does not involve inserting such a tube because the access to the
      pelvis and rectum is gained from above through incision(s) in the abdominal wall.

      The anal sphincter is the medical name for the muscle layers surrounding the opening of the
      anus. The anal sphincter functions as a seal that can be opened to discharge body waste and
      allow the passage of stool. A damage to the anal sphincter can result in inability to fully
      control bowel movements, causing stool (feces) to leak unexpectedly. Because the Trans-anal
      approach involves inserting a tube through the opening of the anus for the duration of the
      surgery, this can lead to a certain degree of stretch and damage to the anal sphincter
      muscles.

      The main aim of this study is to compare the effect of the these two possible approaches to
      perform "Low Anterior Resection" operation on the muscles of the anal sphincter and whether
      they are associated with stool seepage from the anus after the operation.

      Whether the patient is receiving the traditional or trans-anal approach is not related to the
      subject's participation in the study and is decided by the treating surgeon based on medical
      and surgical reasoning.
Primary Objective To evaluate effect of TaTME on anal sphincter via anorectal functional
      studies and anorectal ultrasound administered post- and preoperatively.

      Secondary Objective(s) To evaluate the effect of TaTME on fecal incontinence, quality of
      life, and LARS utilizing validated questionnaires administered to patients preoperatively and
      during postoperative follow-up.

      Study Design This is a prospective two-arm cohort study. The study will include patients
      already undergoing the standard-of-care, low anterior resection (LAR) for middle to low
      rectal cancers. Low anterior resection of the rectum entails a sharp dissection
      circumferentially around the mesorectum in an avascular plane between the visceral and
      parietal layers of the endopelvic fascia in what is known as Total Mesorectal Excision (TME).
      This dissection can be achieved transanally starting down in the pelvis and going up in what
      is known as Transanal Total Mesorectal Excision- (TaTME). It can also be done via an
      up-to-down approach beginning high in the abdomen and going low in the pelvis to achieve
      dissection around the mesorectum. Access in the latter is achieved via laparoscopic or open
      abdominal incisions with minimal anal sphincter dilation. In addition, the level of coloanal
      anastomosis performed is potentially higher from the anal sphincter in comparison to TaTME.
      TaTME on the other hand, involves introducing a special port (gelpoint path) transanally to
      perform the TME dissection. In order to better evaluate the effect of TaTME on anal
      sphincter, it is quintessential to include a control group with minimal anal sphincter
      manipulation, thus the conventional abdominal (open or laparoscopic) TME group will serve as
      a control.
observational model: Cohort
time perspective: Prospective
measure: average change in anal resting pressure
time frame: Up to 6 months post-operation
description: anal resting pressure will be estimated by taking measurements prior to operation and at 3-6 months post-operation. The mean change along with its 95% confidence interval will be reported for both groups
measure: maximum squeeze pressure
time frame: Up to 6 months post-operation
description: maximum squeeze pressure will be estimated by taking measurements prior to operation and at 3-6 months post-operation. The mean change along with its 95% confidence interval will be reported for both groups
measure: Average intra-balloon pressure
time frame: Up to 6 months post-operation
description: Average intra-balloon pressure will be estimated by taking measurements prior to operation and at 3-6 months post-operation. The mean change along with its 95% confidence interval will be reported for both groups
measure: Change in Fecal Incontinence Severity Index Score (FISI)
time frame: From before operation up to 12 weeks after operation
description: Self-Reported, 4-question survey describing frequency of incontinence
measure: Change in Cleveland Clinic Florida Fecal Incontinence (Wexner) score (CCF-FI)
time frame: From before operation up to 12 weeks after operation
description: Self-Reported, 5-question survey scored 0-4 were higher scores indicate greater incontinence
measure: Cleveland Clinic Global Quality of Life score (CGQL)
time frame: From before operation up to 12 weeks after operation
description: Self-Reported, 4-question survey scored 1-10 where higher scores indicate greater quality of life
measure: Low Anterior Resection Syndrome score (LARS)
time frame: From before operation up to 12 weeks after operation
description: Self-Reported, 5-question survey with total scores ranging from 0-42 where higher scores indicating less bowel function
arm group label: TaTME
description: Trans-anal Total Mesorectal Excision (TaTME) is the visualization and dissection of the rectum located deep in the pelvis. In it, a trans-anal port is inserted for the duration of the surgery. Multiple surgical tools are then introduced through the port and the rectum is resected from down-to-up under direct visualization.
arm group label: abdominal TME
description: Total Mesorectal Excision involves resecting the rectum along with its surrounding Mesorectal plane. If the anal sphincter is spared, this surgery is named Low Anterior resection (LAR) for rectal cancer. Traditionally, TME dissection in LAR is performed through open or laparoscopic incisions(s) made in the abdominal wall. Mobilization of the splenic flexure along with sigmoid dissection follows. Lastly, the rectum is dissected in accordance with TME principles from above. This "up-to-down" approach is known as abdominal TME.
intervention type: Procedure
intervention name: TaTME
description: Low anterior resection of the rectum entails a sharp dissection circumferentially around the mesorectum in an avascular plane between the visceral and parietal layers of the endopelvic fascia in what is known as Total Mesorectal Excision. This dissection can be achieved transanally starting down in the pelvis and going up in what is known as Transanal Total Mesorectal Excision
arm group label: TaTME
other name: Trans-anal Total Mesorectal Excision
intervention type: Procedure
intervention name: TME
description: Low anterior resection of the rectum entails a sharp dissection circumferentially around the mesorectum in an avascular plane between the visceral and parietal layers of the endopelvic fascia in what is known as Total Mesorectal Excision. This surgery can also be done via an up-to-down approach beginning high in the abdomen and going low in the pelvis to achieve dissection around the mesorectum.
arm group label: abdominal TME
other name: Total Mesorectal Excision
Surgical specimen will be evaluated by a pathologist as part of the standard of care for the
      quality of resection and TME plane assessment.

      Resections will be categorized as follows: R0-all gross disease resected by enblocresection
      with margins histologically free of disease; R1-all gross disease resected byenblocresection
      with margins histologically positive for disease; and R2-residual gross disease remains
      unresected
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tracy Hull, MD
role: Principal Investigator
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
last name: Tracy Hull, MD
phone: 216-445-6063
email: hullt@ccf.org
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Rectal Neoplasms
mesh term: Fecal Incontinence