<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/NCT04401787</url>
  </required_header>
  <id_info>
    <org_study_id>IR-20780302-1</org_study_id>
    <nct_id>NCT04401787</nct_id>
  </id_info>
  <brief_title>Converted Laparoscopic Resection of Upper Rectal Carcinoma T1-4 N0-1 in Obese Patients.</brief_title>
  <official_title>Is There Better Oncological and Short Term Outcome for Laparoscopic Resection of Upper Rectal Carcinoma T1-4 N0-1 Over Laparoscopic Converted Cases in Obese Patients?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</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>
      Background: laparoscopic resection (LAR) is a safe approach and widely used for rectal cancer&#xD;
      after neoadjuvant chemo-radiotherapy, but short term and oncological outcome for converted&#xD;
      cases to open surgery (cLAR), may be questioned in an obese patient.&#xD;
&#xD;
      Objective: validating the short-term and oncological outcomes after laparoscopic resection&#xD;
      and after conversion to open surgery for upper rectal cancer in obese patients.&#xD;
&#xD;
      Patients and methods: A prospective study included 191 patients, randomly allocated into two&#xD;
      arms of the study, Arm I is open anterior resection (OAR), this is the control and arm II,&#xD;
      The LAR. Only 156 analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: A randomized control study assigned to involve obese patients with BMI 30&#xD;
      diagnosed with upper rectal carcinoma T1-4 N0-1, 181 patients assigned into two arms and&#xD;
      operated in multi-centres in a tertiary hospitals.&#xD;
&#xD;
      Ethical approval and clinical registration: Our study was submitted, revised and finally&#xD;
      permitted and approved by the Institutional Review Board of the Zagazig University hospital,&#xD;
      faculty of medicine, holding number IR-20780302-1, and informed consent was obtained from all&#xD;
      participants agreed to be involved. Study registered in ClinicalTrial.gove: ID: ………&#xD;
&#xD;
      Protocol and setting:&#xD;
&#xD;
      A study was done in the period from December 2016 to December 2019 and data registered after&#xD;
      each procedure in our database system The controlled arm included patients underwent open&#xD;
      anterior resection (OAR) for upper rectal carcinoma and divided into Ia, underwent OAR and&#xD;
      IIa, included patients with cLAR, whereas Group II included patients underwent LAR.&#xD;
&#xD;
      Method of randomization:&#xD;
&#xD;
      Randomization was done via a computer-generated protocol, already designed and uploaded in&#xD;
      our database, and the results were unlabeled and sealed into envelopes. These envelopes were&#xD;
      opened in the operating room by the head-nurse and an assistant surgery specialist who was&#xD;
      not engaged in the study&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
      Obese patients with BMI ≥27 with operable upper rectal carcinoma staged T1-4 N0-1 based on&#xD;
      colonoscopy, endo-rectal ultrasound, CT abdomen and pelvis and MRI abdomen Exclusion criteria&#xD;
      BMI less than 27, According to AJCC TNM staging 7th edition, N2-3 patients were excluded, any&#xD;
      evidence of inoperability whether distant metastasis or invasive tumours, Patients with&#xD;
      synchronous colorectal tumours, synchronous liver metastasis obstructive symptomatic patients&#xD;
      and patients with intraoperative tumour rupture or perforation, rectal tumours below&#xD;
      peritoneal reflection.&#xD;
&#xD;
      There are 2 parameters prospectively assessed and registered in our database: First the&#xD;
      clinical parameters, second is the onco-pathological parameter Clinical parameter included,&#xD;
      operative basic demographic data (age, sex and BMI), peri-operative clinical variables (&#xD;
      operative time, intraoperative complication, completeness of TME, the feasibility of&#xD;
      stapling, causes of conversion if there, postoperative (PO) short term outcome, Recovery,&#xD;
      hospital stay, PO morbidity and bowel function.&#xD;
&#xD;
      The onco-pathological outcome included: tumour site, site and staging of tumour according to&#xD;
      TNM- longitudinal and circumferential resection margin- LN involved (N) - loco-regional&#xD;
      recurrence and recurrence-free survival.&#xD;
&#xD;
      Intervention methods The preoperative nCRT: our protocol according to a multidisciplinary&#xD;
      tumour board committee, is to give a long course of neo-adjuvant chemo-radiotherapy for mid&#xD;
      and lower rectal cancer but upper rectum, we give a 4 weeks course of CRT, 45 Gy with&#xD;
      systemic 5-fluorouracil based regimen infusion. This is proposed for stage II-III not stage&#xD;
      I.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2016</start_date>
  <completion_date type="Actual">May 18, 2020</completion_date>
  <primary_completion_date type="Actual">December 29, 2019</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>
    <intervention_model_description>A prospective study included 191 patients, randomly allocated into two arms of the study, Arm I is open anterior resection (OAR), this is the control and arm II, The LAR. Only 156 analyzed.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>recovery time-intraoperative bleeding</measure>
    <time_frame>up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of wound infection</measure>
    <time_frame>up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>hospital stay-perioperative length</measure>
    <time_frame>up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>oncological outcome</measure>
    <time_frame>3 years</time_frame>
    <description>total mesorectal excision, margin included or not</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>early locoregional recurrence</measure>
    <time_frame>6 months</time_frame>
    <description>early locoregional recurrence within 6 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Cancer, Rectum</condition>
  <arm_group>
    <arm_group_label>laparoscopic anterior resection (LAR)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>LAR group included 88 patients, 17 patients converted to open</description>
  </arm_group>
  <arm_group>
    <arm_group_label>open anterior resection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Open anterior resection for 56 patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anterior resection for upper rectal cancer in obese</intervention_name>
    <description>Anterior resection for upper rectal cancer in obese</description>
    <arm_group_label>laparoscopic anterior resection (LAR)</arm_group_label>
    <arm_group_label>open anterior resection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obese patients with BMI ≥27 with operable upper rectal carcinoma staged T1-4 N0-1&#xD;
             based on colonoscopy, endo-rectal ultrasound, CT abdomen and pelvis and MRI abdomen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI less than 27, According to AJCC TNM staging 7th edition, N2-3 patients were&#xD;
             excluded, any evidence of inoperability whether distant metastasis or invasive&#xD;
             tumours, Patients with synchronous colorectal tumours, synchronous liver metastasis&#xD;
             obstructive symptomatic patients and patients with intraoperative tumour rupture or&#xD;
             perforation, rectal tumours below peritoneal reflection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>26 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>https://link.springer.com/article/10.1007/s12262-020-02299-4</url>
    <description>Total Laparoscopic Approach for Rectal Cancer Resection-a Novel Technique and Review of the Literature</description>
  </link>
  <results_reference>
    <citation>Kinlen D, Cody D, O'Shea D. Complications of obesity. QJM. 2018 Jul 1;111(7):437-443. doi: 10.1093/qjmed/hcx152.</citation>
    <PMID>29025162</PMID>
  </results_reference>
  <results_reference>
    <citation>Allaix ME, Furnee E, Esposito L, Mistrangelo M, Rebecchi F, Arezzo A, Morino M. Analysis of Early and Long-Term Oncologic Outcomes After Converted Laparoscopic Resection Compared to Primary Open Surgery for Rectal Cancer. World J Surg. 2018 Oct;42(10):3405-3414. doi: 10.1007/s00268-018-4614-x.</citation>
    <PMID>29610930</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Bassem Mohamed Sieda</investigator_full_name>
    <investigator_title>Assistant professor of general surgery</investigator_title>
  </responsible_party>
  <keyword>rectal cancer</keyword>
  <keyword>laparoscopic resection</keyword>
  <keyword>obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>through international publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>1 year</ipd_time_frame>
    <ipd_access_criteria>laparoscopic anterior resection for upper rectal cancer in obese patients</ipd_access_criteria>
  </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/NCT04401787
org study id: IR-20780302-1
nct id: NCT04401787
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: laparoscopic resection (LAR) is a safe approach and widely used for rectal cancer
      after neoadjuvant chemo-radiotherapy, but short term and oncological outcome for converted
      cases to open surgery (cLAR), may be questioned in an obese patient.

      Objective: validating the short-term and oncological outcomes after laparoscopic resection
      and after conversion to open surgery for upper rectal cancer in obese patients.

      Patients and methods: A prospective study included 191 patients, randomly allocated into two
      arms of the study, Arm I is open anterior resection (OAR), this is the control and arm II,
      The LAR. Only 156 analyzed.
Study design: A randomized control study assigned to involve obese patients with BMI 30
      diagnosed with upper rectal carcinoma T1-4 N0-1, 181 patients assigned into two arms and
      operated in multi-centres in a tertiary hospitals.

      Ethical approval and clinical registration: Our study was submitted, revised and finally
      permitted and approved by the Institutional Review Board of the Zagazig University hospital,
      faculty of medicine, holding number IR-20780302-1, and informed consent was obtained from all
      participants agreed to be involved. Study registered in ClinicalTrial.gove: ID: ………

      Protocol and setting:

      A study was done in the period from December 2016 to December 2019 and data registered after
      each procedure in our database system The controlled arm included patients underwent open
      anterior resection (OAR) for upper rectal carcinoma and divided into Ia, underwent OAR and
      IIa, included patients with cLAR, whereas Group II included patients underwent LAR.

      Method of randomization:

      Randomization was done via a computer-generated protocol, already designed and uploaded in
      our database, and the results were unlabeled and sealed into envelopes. These envelopes were
      opened in the operating room by the head-nurse and an assistant surgery specialist who was
      not engaged in the study

      Inclusion criteria:

      Obese patients with BMI ≥27 with operable upper rectal carcinoma staged T1-4 N0-1 based on
      colonoscopy, endo-rectal ultrasound, CT abdomen and pelvis and MRI abdomen Exclusion criteria
      BMI less than 27, According to AJCC TNM staging 7th edition, N2-3 patients were excluded, any
      evidence of inoperability whether distant metastasis or invasive tumours, Patients with
      synchronous colorectal tumours, synchronous liver metastasis obstructive symptomatic patients
      and patients with intraoperative tumour rupture or perforation, rectal tumours below
      peritoneal reflection.

      There are 2 parameters prospectively assessed and registered in our database: First the
      clinical parameters, second is the onco-pathological parameter Clinical parameter included,
      operative basic demographic data (age, sex and BMI), peri-operative clinical variables (
      operative time, intraoperative complication, completeness of TME, the feasibility of
      stapling, causes of conversion if there, postoperative (PO) short term outcome, Recovery,
      hospital stay, PO morbidity and bowel function.

      The onco-pathological outcome included: tumour site, site and staging of tumour according to
      TNM- longitudinal and circumferential resection margin- LN involved (N) - loco-regional
      recurrence and recurrence-free survival.

      Intervention methods The preoperative nCRT: our protocol according to a multidisciplinary
      tumour board committee, is to give a long course of neo-adjuvant chemo-radiotherapy for mid
      and lower rectal cancer but upper rectum, we give a 4 weeks course of CRT, 45 Gy with
      systemic 5-fluorouracil based regimen infusion. This is proposed for stage II-III not stage
      I.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A prospective study included 191 patients, randomly allocated into two arms of the study, Arm I is open anterior resection (OAR), this is the control and arm II, The LAR. Only 156 analyzed.
primary purpose: Treatment
masking: Single (Participant)
measure: recovery time-intraoperative bleeding
time frame: up to 3 years
measure: Incidence of wound infection
time frame: up to 3 years
measure: hospital stay-perioperative length
time frame: up to 3 years
measure: oncological outcome
time frame: 3 years
description: total mesorectal excision, margin included or not
measure: early locoregional recurrence
time frame: 6 months
description: early locoregional recurrence within 6 months
arm group label: laparoscopic anterior resection (LAR)
arm group type: Active Comparator
description: LAR group included 88 patients, 17 patients converted to open
arm group label: open anterior resection
arm group type: Active Comparator
description: Open anterior resection for 56 patients
intervention type: Procedure
intervention name: Anterior resection for upper rectal cancer in obese
description: Anterior resection for upper rectal cancer in obese
arm group label: laparoscopic anterior resection (LAR)
arm group label: open anterior resection
criteria: 
gender: All
minimum age: 26 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
url: https://link.springer.com/article/10.1007/s12262-020-02299-4
description: Total Laparoscopic Approach for Rectal Cancer Resection-a Novel Technique and Review of the Literature
citation: Kinlen D, Cody D, O'Shea D. Complications of obesity. QJM. 2018 Jul 1;111(7):437-443. doi: 10.1093/qjmed/hcx152.
PMID: 29025162
citation: Allaix ME, Furnee E, Esposito L, Mistrangelo M, Rebecchi F, Arezzo A, Morino M. Analysis of Early and Long-Term Oncologic Outcomes After Converted Laparoscopic Resection Compared to Primary Open Surgery for Rectal Cancer. World J Surg. 2018 Oct;42(10):3405-3414. doi: 10.1007/s00268-018-4614-x.
PMID: 29610930
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Bassem Mohamed Sieda
investigator title: Assistant professor of general surgery
mesh term: Rectal Neoplasms
sharing ipd: Yes
ipd description: through international publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 1 year
ipd access criteria: laparoscopic anterior resection for upper rectal cancer in obese patients