<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/NCT01682395</url>
  </required_header>
  <id_info>
    <org_study_id>12-1091</org_study_id>
    <nct_id>NCT01682395</nct_id>
  </id_info>
  <brief_title>Best Management of Sigmoid Volvulus: A Prospective Randomized Trial</brief_title>
  <official_title>Best Management of Sigmoid Volvulus: A Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to obtain a better understanding of the best management of&#xD;
      left-sided colonic emergencies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants: Patients 18 years or older presenting to Kamuzu Central Hospital in Lilongwe&#xD;
      Malawi with sigmoid volvulus will be eligible for inclusion.&#xD;
&#xD;
      Procedures (methods): This is a prospective randomized trial. Subjects will be randomized&#xD;
      during surgery to receive resection and anastomosis or mesosigmoidopexy (for non-gangrenous&#xD;
      sigmoid volvulus), and resection and anastomosis or Hartmann's procedure (for gangrenous&#xD;
      sigmoid volvulus).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>30-Day</time_frame>
    <description>Mortality within 30 days of surgery, as determined by hospital inpatient records, outpatient clinical records and telephone contact (with next-of-kin)per study protocol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence of Sigmoid Volvulus</measure>
    <time_frame>3 Year</time_frame>
    <description>Recurrence of sigmoid volvulus confirmed radiologically or operatively within 3 years of surgery. This will be determined by hospital inpatient records, outpatient clinical records and telephone contact (with next-of-kin, and if recurrence diagnosed outside of study site contact with the treating physician) per study protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical Site Infection</measure>
    <time_frame>30-Day</time_frame>
    <description>Surgical site infections as defined by the Centers for Disease Control within 30 days of surgery.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Anastomotic Leak</measure>
    <time_frame>30-Day</time_frame>
    <description>Communication of the intraluminal and extraluminal space ad defined by clinical presence of a fecal fistula or operative determination of breakdown of the anastomosis within 30 days of surgery. Of note the NG-SV mesosigmoidopexy arm will not be included in this outcome as there is no anastomosis.</description>
  </other_outcome>
  <other_outcome>
    <measure>Stomal Complications</measure>
    <time_frame>3 Year</time_frame>
    <description>Stomal complications (necrosis, pain, skin irritation, retraction, prolapse, stenosis, parastomal herniation, ventral hernia at prior stoma incision) within 3 years of surgery. Of note the G-SV Resection and colostomy arm will be the only arm included in this outcome as none of the other arms include a colostomy.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Intestinal Volvulus</condition>
  <condition>Colon, Sigmoid</condition>
  <arm_group>
    <arm_group_label>G-SV Resection and colostomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gangrenous sigmoid volvulus patients randomized to undergo resection with colostomy and delayed anastomosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>G-SV Resection and anastomosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NG-SV resection and anastomosis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nongangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NG-SV mesosigmoidopexy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nongangrenous sigmoid volvulus subjects randomized to undergo mesosigmoidopexy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Resection and anastomosis</intervention_name>
    <description>Resection of sigmoid colon with primary anastomosis</description>
    <arm_group_label>G-SV Resection and anastomosis</arm_group_label>
    <arm_group_label>NG-SV resection and anastomosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Resection and colostomy</intervention_name>
    <description>Resection of sigmoid colon with end colostomy and Hartmann's pouch, followed at a later date by Hartmann's reversal as a second surgical procedure</description>
    <arm_group_label>G-SV Resection and colostomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mesosigmoidopexy</intervention_name>
    <description>Mesosigmoidopexy--the fixation of the sigmoid colon to lateral abdominal wall with concomitant shortening of the mesosigmoid length.</description>
    <arm_group_label>NG-SV mesosigmoidopexy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical suspicion of sigmoid volvulus as deemed by the surgeon on duty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  age under 18 years,&#xD;
&#xD;
          -  prisoners&#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>Jonathan C Samuel, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNC Chapel Hill Department of Surgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kamuzu Central Hospital</name>
      <address>
        <city>Lilongwe</city>
        <country>Malawi</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malawi</country>
  </location_countries>
  <link>
    <url>http://www.crd.york.ac.uk/prospero/display_record.asp?ID=CRD42012002137</url>
    <description>Related meta-analysis and systematic review registration</description>
  </link>
  <reference>
    <citation>Raveenthiran V, Madiba TE, Atamanalp SS, De U. Volvulus of the sigmoid colon. Colorectal Dis. 2010 Jul;12(7 Online):e1-17. doi: 10.1111/j.1463-1318.2010.02262.x. Epub 2010 Mar 10.</citation>
    <PMID>20236153</PMID>
  </reference>
  <reference>
    <citation>Akinkuotu A, Samuel JC, Msiska N, Mvula C, Charles AG. The role of the anatomy of the sigmoid colon in developing sigmoid volvulus: a case-control study. Clin Anat. 2011 Jul;24(5):634-7. doi: 10.1002/ca.21131. Epub 2011 Feb 14.</citation>
    <PMID>21322064</PMID>
  </reference>
  <reference>
    <citation>Samuel JC, Msiska N, Muyco AP, Cairns BA, Charles AG. An observational study addressing the anatomic basis of mesosigmoidopexy as a rational treatment of non-gangrenous sigmoid volvulus. Trop Doct. 2012 Jan;42(1):44-5. doi: 10.1258/td.2011.110317. Epub 2011 Dec 19.</citation>
    <PMID>22184737</PMID>
  </reference>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>December 8, 2017</last_update_submitted>
  <last_update_submitted_qc>December 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intestinal volvulus</keyword>
  <keyword>Colon, sigmoid</keyword>
  <keyword>Anastomosis, surgical</keyword>
  <keyword>Anastomotic leak</keyword>
  <keyword>Malawi</keyword>
  <keyword>Developing Country</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Volvulus</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/NCT01682395
org study id: 12-1091
nct id: NCT01682395
lead sponsor: 
has dmc: Yes
The purpose of this study is to obtain a better understanding of the best management of
      left-sided colonic emergencies.
Participants: Patients 18 years or older presenting to Kamuzu Central Hospital in Lilongwe
      Malawi with sigmoid volvulus will be eligible for inclusion.

      Procedures (methods): This is a prospective randomized trial. Subjects will be randomized
      during surgery to receive resection and anastomosis or mesosigmoidopexy (for non-gangrenous
      sigmoid volvulus), and resection and anastomosis or Hartmann's procedure (for gangrenous
      sigmoid volvulus).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mortality
time frame: 30-Day
description: Mortality within 30 days of surgery, as determined by hospital inpatient records, outpatient clinical records and telephone contact (with next-of-kin)per study protocol.
measure: Recurrence of Sigmoid Volvulus
time frame: 3 Year
description: Recurrence of sigmoid volvulus confirmed radiologically or operatively within 3 years of surgery. This will be determined by hospital inpatient records, outpatient clinical records and telephone contact (with next-of-kin, and if recurrence diagnosed outside of study site contact with the treating physician) per study protocol.
measure: Surgical Site Infection
time frame: 30-Day
description: Surgical site infections as defined by the Centers for Disease Control within 30 days of surgery.
measure: Anastomotic Leak
time frame: 30-Day
description: Communication of the intraluminal and extraluminal space ad defined by clinical presence of a fecal fistula or operative determination of breakdown of the anastomosis within 30 days of surgery. Of note the NG-SV mesosigmoidopexy arm will not be included in this outcome as there is no anastomosis.
measure: Stomal Complications
time frame: 3 Year
description: Stomal complications (necrosis, pain, skin irritation, retraction, prolapse, stenosis, parastomal herniation, ventral hernia at prior stoma incision) within 3 years of surgery. Of note the G-SV Resection and colostomy arm will be the only arm included in this outcome as none of the other arms include a colostomy.
arm group label: G-SV Resection and colostomy
arm group type: Active Comparator
description: Gangrenous sigmoid volvulus patients randomized to undergo resection with colostomy and delayed anastomosis
arm group label: G-SV Resection and anastomosis
arm group type: Experimental
description: Gangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis
arm group label: NG-SV resection and anastomosis
arm group type: Active Comparator
description: Nongangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis
arm group label: NG-SV mesosigmoidopexy
arm group type: Experimental
description: Nongangrenous sigmoid volvulus subjects randomized to undergo mesosigmoidopexy
intervention type: Procedure
intervention name: Resection and anastomosis
description: Resection of sigmoid colon with primary anastomosis
arm group label: G-SV Resection and anastomosis
arm group label: NG-SV resection and anastomosis
intervention type: Procedure
intervention name: Resection and colostomy
description: Resection of sigmoid colon with end colostomy and Hartmann's pouch, followed at a later date by Hartmann's reversal as a second surgical procedure
arm group label: G-SV Resection and colostomy
intervention type: Procedure
intervention name: Mesosigmoidopexy
description: Mesosigmoidopexy--the fixation of the sigmoid colon to lateral abdominal wall with concomitant shortening of the mesosigmoid length.
arm group label: NG-SV mesosigmoidopexy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jonathan C Samuel, MD, MPH
role: Principal Investigator
affiliation: UNC Chapel Hill Department of Surgery
facility: 
country: Malawi
url: http://www.crd.york.ac.uk/prospero/display_record.asp?ID=CRD42012002137
description: Related meta-analysis and systematic review registration
citation: Raveenthiran V, Madiba TE, Atamanalp SS, De U. Volvulus of the sigmoid colon. Colorectal Dis. 2010 Jul;12(7 Online):e1-17. doi: 10.1111/j.1463-1318.2010.02262.x. Epub 2010 Mar 10.
PMID: 20236153
citation: Akinkuotu A, Samuel JC, Msiska N, Mvula C, Charles AG. The role of the anatomy of the sigmoid colon in developing sigmoid volvulus: a case-control study. Clin Anat. 2011 Jul;24(5):634-7. doi: 10.1002/ca.21131. Epub 2011 Feb 14.
PMID: 21322064
citation: Samuel JC, Msiska N, Muyco AP, Cairns BA, Charles AG. An observational study addressing the anatomic basis of mesosigmoidopexy as a rational treatment of non-gangrenous sigmoid volvulus. Trop Doct. 2012 Jan;42(1):44-5. doi: 10.1258/td.2011.110317. Epub 2011 Dec 19.
PMID: 22184737
responsible party type: Sponsor
mesh term: Intestinal Volvulus