<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/NCT03026738</url>
  </required_header>
  <id_info>
    <org_study_id>AssiutU4988</org_study_id>
    <nct_id>NCT03026738</nct_id>
  </id_info>
  <brief_title>Anterior Versus Posterior Laparoscopic Mesh Rectopexy For Rectal Prolapse; a Randomized Controlled Trial.</brief_title>
  <official_title>Anterior Versus Posterior Laparoscopic Mesh Rectopexy For Rectal Prolapse; a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of this work is to compare results between Laparoscopic Anterior Mesh Rectopexy and&#xD;
      Laparoscopic Posterior Mesh Rectopexy for patients with rectal prolapse by assessment of&#xD;
      operative time, intraoperative blood loss , intraoperative organ injury, overall length of&#xD;
      hospital stay, recurrence,and improvement of incontinence and constipation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rectal prolapse is a disabling condition, which is more common in females and increases in&#xD;
      frequency with age.&#xD;
&#xD;
      There are two types of rectal prolapse; external and internal. External rectal prolapse is a&#xD;
      circumferential protrusion of all layers of the rectum through the anal sphincter. Internal&#xD;
      rectal prolapse, also referred to as rectal intussusception.&#xD;
&#xD;
      The majority of patients with a RP suffer from symptoms of fecal incontinence and&#xD;
      constipation, causing a significant negative impact on quality of life.&#xD;
&#xD;
      The aims of the surgical treatment are to correct the anatomical abnormality and to cure the&#xD;
      accompanying symptoms of incontinence, constipation and pain, with the lowest rate of&#xD;
      complications as possible and an acceptable rate of recurrence.&#xD;
&#xD;
      Since the emergence of minimally invasive surgery, laparoscopic techniques for the treatment&#xD;
      for RP have been applied in patients of all ages.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>improvement of incontinence and / or constipation.</measure>
    <time_frame>1 year postoperatively</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>recurrence rate</measure>
    <time_frame>1 year postoperatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Surgery</measure>
    <time_frame>intraoperative</time_frame>
    <description>The duration of the procedure will be registered in minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peri-operative blood loss</measure>
    <time_frame>during surgery, 1 day</time_frame>
    <description>Blood loss will be measured in milliliters</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Rectal Prolapse</condition>
  <arm_group>
    <arm_group_label>Laparoscopic anterior mesh rectopexy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A superficial peritoneal window will be made over the right part of the sacral promontory and extended caudally over the right outer border of the mesorectum down to the right side of the pouch of Douglas. In females, the vagina will be retracted anteriorly and a careful dissection of the rectovaginal septum will be performed down to the pelvic floor. A strip of polypropylene (3×20 cm) mesh will be introduced and sutured as distally as possible on the anterior rectal wall/ perineal body with three, interrupted nonabsorbable sutures.The posterior wall of the vagina will be fixed to the mesh using absorbable sutures. The mesh is then secured tension-free to the sacral promontory using three absorbable sutures. The mesh will be peritonealized by suturing the free edges of the previously divided peritoneum over the mesh to provide additional ventral elevation of the enterocele and avoid small bowel adhesions to the mesh.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic posterior mesh rectopexy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mobilization of the mesorectum posteriorly from the sacral promontory to the pelvic floor. Lateral stalks will not be divided. Bowel resection and circumferential division of the peritoneum will not be done in this study. A T-shaped polypropylene mesh will be placed with the vertical &quot;leg&quot; laying flush with the anterior surface of the sacrum, and secured to the promontory and sacrum with three absorbable sutures. The mesh &quot;wings&quot; will be sutured to the lateral sides of the rectum/mesorectum with two absorbable sutures on each side. The visceral peritoneum will be left open.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic anterior mesh rectopexy</intervention_name>
    <description>fixation of the rectum anteriorly using laparosopy and polypropylene mesh</description>
    <arm_group_label>Laparoscopic anterior mesh rectopexy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic posterior mesh rectopexy</intervention_name>
    <description>fixation of the rectum posteriorly using laparosopy and polypropylene mesh</description>
    <arm_group_label>Laparoscopic posterior mesh rectopexy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>polypropylene mesh</intervention_name>
    <description>A strip of polypropylene mesh will be introduced and sutured.</description>
    <arm_group_label>Laparoscopic anterior mesh rectopexy</arm_group_label>
    <arm_group_label>Laparoscopic posterior mesh rectopexy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients with rectal prolapse either external or internal prolapse&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 18 years.&#xD;
&#xD;
          -  Pregnancy or breast-feeding.&#xD;
&#xD;
          -  Recurrence of rectal prolapse.&#xD;
&#xD;
          -  patients with previous complicated abdominal surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 14, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ibrahim Mostafa Ahmed Abdel Aal</investigator_full_name>
    <investigator_title>Assistant lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Prolapse</mesh_term>
    <mesh_term>Prolapse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03026738
org study id: AssiutU4988
nct id: NCT03026738
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
Aim of this work is to compare results between Laparoscopic Anterior Mesh Rectopexy and
      Laparoscopic Posterior Mesh Rectopexy for patients with rectal prolapse by assessment of
      operative time, intraoperative blood loss , intraoperative organ injury, overall length of
      hospital stay, recurrence,and improvement of incontinence and constipation.
Rectal prolapse is a disabling condition, which is more common in females and increases in
      frequency with age.

      There are two types of rectal prolapse; external and internal. External rectal prolapse is a
      circumferential protrusion of all layers of the rectum through the anal sphincter. Internal
      rectal prolapse, also referred to as rectal intussusception.

      The majority of patients with a RP suffer from symptoms of fecal incontinence and
      constipation, causing a significant negative impact on quality of life.

      The aims of the surgical treatment are to correct the anatomical abnormality and to cure the
      accompanying symptoms of incontinence, constipation and pain, with the lowest rate of
      complications as possible and an acceptable rate of recurrence.

      Since the emergence of minimally invasive surgery, laparoscopic techniques for the treatment
      for RP have been applied in patients of all ages.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: improvement of incontinence and / or constipation.
time frame: 1 year postoperatively
measure: recurrence rate
time frame: 1 year postoperatively
measure: Duration of Surgery
time frame: intraoperative
description: The duration of the procedure will be registered in minutes.
measure: Peri-operative blood loss
time frame: during surgery, 1 day
description: Blood loss will be measured in milliliters
arm group label: Laparoscopic anterior mesh rectopexy
arm group type: Experimental
description: A superficial peritoneal window will be made over the right part of the sacral promontory and extended caudally over the right outer border of the mesorectum down to the right side of the pouch of Douglas. In females, the vagina will be retracted anteriorly and a careful dissection of the rectovaginal septum will be performed down to the pelvic floor. A strip of polypropylene (3×20 cm) mesh will be introduced and sutured as distally as possible on the anterior rectal wall/ perineal body with three, interrupted nonabsorbable sutures.The posterior wall of the vagina will be fixed to the mesh using absorbable sutures. The mesh is then secured tension-free to the sacral promontory using three absorbable sutures. The mesh will be peritonealized by suturing the free edges of the previously divided peritoneum over the mesh to provide additional ventral elevation of the enterocele and avoid small bowel adhesions to the mesh.
arm group label: Laparoscopic posterior mesh rectopexy
arm group type: Active Comparator
description: Mobilization of the mesorectum posteriorly from the sacral promontory to the pelvic floor. Lateral stalks will not be divided. Bowel resection and circumferential division of the peritoneum will not be done in this study. A T-shaped polypropylene mesh will be placed with the vertical "leg" laying flush with the anterior surface of the sacrum, and secured to the promontory and sacrum with three absorbable sutures. The mesh "wings" will be sutured to the lateral sides of the rectum/mesorectum with two absorbable sutures on each side. The visceral peritoneum will be left open.
intervention type: Procedure
intervention name: Laparoscopic anterior mesh rectopexy
description: fixation of the rectum anteriorly using laparosopy and polypropylene mesh
arm group label: Laparoscopic anterior mesh rectopexy
intervention type: Procedure
intervention name: Laparoscopic posterior mesh rectopexy
description: fixation of the rectum posteriorly using laparosopy and polypropylene mesh
arm group label: Laparoscopic posterior mesh rectopexy
intervention type: Device
intervention name: polypropylene mesh
description: A strip of polypropylene mesh will be introduced and sutured.
arm group label: Laparoscopic anterior mesh rectopexy
arm group label: Laparoscopic posterior mesh rectopexy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ibrahim Mostafa Ahmed Abdel Aal
investigator title: Assistant lecturer
mesh term: Rectal Prolapse
mesh term: Prolapse
sharing ipd: Undecided