xml: <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/NCT05985252</url>
    </required_header>
    <id_info>
      <org_study_id>GS-RCT</org_study_id>
      <nct_id>NCT05985252</nct_id>
    </id_info>
    <brief_title>Virtual Ileostomy Versus Conventional Loop Ileostomy</brief_title>
    <official_title>Virtual Ileostomy Versus Conventional Loop Ileostomy in Patients Undergoing Low Anterior Resection for Rectal Cancer: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</source>
    <oversight_info>
      <has_dmc>No</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>
        This study aimed at comparing the Comprehensive Complication Index (CCI), readmission rates,&#xD;
        postoperative hospitalization days, duration of bearing the stoma (months), hospitalization&#xD;
        costs, the number of hospitalizations with ghost ileostomy versus conventional loop ileostomy&#xD;
        after low anterior resection for rectal cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Diverting ileostomy (DI) is a common procedure performed in patients undergoing low anterior&#xD;
        resection for rectal cancer to protect the anastomosis and reduce the risk of complications.&#xD;
        Although DI remains one of the most common methods used in clinical practice to prevent&#xD;
        anastomotic leakage, there is still considerable debate in clinical practice about whether to&#xD;
        perform a routine ileostomy. Despite temporary ileostomy fecal diversion can reduce the&#xD;
        development of abdominal abscesses, wound inflammation, peritonitis, and sepsis after the&#xD;
        occurrence of AL, however, it not only failed to reduce the incidence of AL but significantly&#xD;
        increased the risk of non-elective readmissions and reinterventions as well as higher total&#xD;
        costs. Meanwhile, stoma significantly increase the risk of stoma-related complication such as&#xD;
        small bowel obstruction, postoperative ileus, dehydration from high-output stoma culminating&#xD;
        in acute kidney injury, electrolyte imbalance, stoma stenosis/ necrosis, parastomal hernia,&#xD;
        peristomal abscess, and fistula, etc.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2025</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>Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient</measure>
      <time_frame>An average of 1 year from the date of low anterior resection for rectal cancer until the date of when the patient's condition is stabilized without complications</time_frame>
      <description>The Comprehensive Complication Index (CCI)summarises all postoperative complications based on the established Clavien-Dindo classification (ranging from mild complications not leading to a deviation from the normal clinical course (grade I) up to postoperative death (grade V)) at an individual patient level according to their grade of severity.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Postoperative hospitalization days</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Patients in the virtual stoma group who did not have a second surgery due to complications recorded days of postoperative hospitalization after low anterior resection for rectal cancer, if the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record days of postoperative hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmission rates</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Patients in the virtual stoma group who did not have a second surgery due to complications recorded the number of hospitalization after low anterior resection for rectal cancer. If the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the number of hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The number of hospitalizations</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Patients in the virtual stoma group who did not have a second surgery due to complications recorded the number of hospitalization after low anterior resection for rectal cancer. If the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the number of hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of bearing the stoma (months)</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>If the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the duration of bearing the stoma since the data of surgery of diverting ileostomy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>First hospitalization costs</measure>
      <time_frame>During hospitalization,approximately 7 days</time_frame>
      <description>Patient hospitalization costs for radical resection of rectal cancer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total hospitalization costs</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Patients in the virtual stoma group who did not have a second surgery due to complications recorded the costs after low anterior resection for rectal cancer, if the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the costs due to complications and reoperation since the data of low anterior resection for rectal cancer.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Whether patients undergo terminal ostomy after low anterior resection for rectal cancer.</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Hartmann's procedure or for example, abdominoperineal extirpation</description>
    </other_outcome>
    <other_outcome>
      <measure>Patients with stoma (terminal/loop) at 6 months after initial surgery</measure>
      <time_frame>6 months from the date of low anterior resection for rectal cancer</time_frame>
      <description>Patients carrying stoma 6 months after low anterior resection for rectal cancer.</description>
    </other_outcome>
    <other_outcome>
      <measure>The number of participants with virtual ileostomy converted to diverting ileostomy</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>The virtual stoma required bedside or secondary surgery for diverting ileostomy due to complications.</description>
    </other_outcome>
    <other_outcome>
      <measure>The number of patients who required secondary abdominal surgery under general anesthesia due to complications</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Patient undergoes second abdominal surgery for complications after first surgery</description>
    </other_outcome>
    <other_outcome>
      <measure>Ghost ileostomy remove time</measure>
      <time_frame>During hospitalization,approximately 7 days</time_frame>
      <description>Duration of days from the date of radical resection of rectal cancer to virtual stoma removed.</description>
    </other_outcome>
    <other_outcome>
      <measure>The number of patients with complications after low anterior resection for rectal cancer</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Abdominal abscess,Anastomotic bleeding,Pelvic infection,Surgical incision infection, Peritonitis,Interventional drainage ,ileostomy wounds/abscesses/edema/dermatitis/ ulcers,Parastomal hernia ,Stoma prolapse,Anastomotic separation/poor healing, Anastomotic stenosis,Anastomotic leakage,Bowel obstruction,Anastomotic bowel necrosis ,Wound dehiscence / bleeding / sinus tract / abscess/fat liquefaction,Acute kidney injury ,Dehydration/output &gt;1500 mL/day,Converted to permanent ileostomy,Intestinal fistula,Incisional hernia ,fecal incontinence.</description>
    </other_outcome>
    <other_outcome>
      <measure>Adjuvant chemotherapy in patients after low anterior resection for rectal cancer.</measure>
      <time_frame>6 months from the date of low anterior resection for rectal cancer</time_frame>
      <description>Whether the patient has completed chemotherapy.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Rectal Neoplasms</condition>
    <arm_group>
      <arm_group_label>Virtual ileostomy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Laparoscopic or robotic surgery with virtual ileostomy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Diverting ileostomy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Laparoscopic or robotic surgery with diverting ileostomy</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Virtual ileostomy</intervention_name>
      <description>Laparoscopic or robotic surgery with virtual ileostomy</description>
      <arm_group_label>Virtual ileostomy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Diverting ileostomy</intervention_name>
      <description>Laparoscopic or robotic surgery with diverting ileostomy</description>
      <arm_group_label>Diverting ileostomy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pathologically confirmed low to intermediate level rectal cancer, with the lower&#xD;
               margin of anastomosis &lt;10cm from the anus.&#xD;
  &#xD;
            -  age ≥18 years and ≤80 years.&#xD;
  &#xD;
            -  the surgical procedure is anterior rectal resection (LAR).&#xD;
  &#xD;
            -  intraoperative virtual or conventional ileostomy was performed.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  BMI &gt;30 kg/m².&#xD;
  &#xD;
            -  ASA score &gt;3.&#xD;
  &#xD;
            -  Patients with coexisting complete intestinal obstruction.&#xD;
  &#xD;
            -  History of long-term use of immunosuppressive drugs or glucocorticoids.&#xD;
  &#xD;
            -  Combined severe cardiac disease: with congestive heart failure or NYHA cardiac&#xD;
               function ≥ grade 2. Patients with a history of myocardial infarction or coronary&#xD;
               artery surgery within 6 months prior to the procedure.&#xD;
  &#xD;
            -  chronic renal failure (requiring dialysis or glomerular filtration rate &lt;30 mL/min).&#xD;
  &#xD;
          Intraoperative combined multi-organ resection.&#xD;
  &#xD;
            -  Combined cirrhosis of the liver.&#xD;
  &#xD;
            -  Intraoperative findings of incomplete anastomosis and positive insufflation test.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>fan li</last_name>
      <role>Principal Investigator</role>
      <affiliation>Daping Hospital, Third Military Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>fan li</last_name>
      <phone>+86 023 68757958</phone>
      <email>levinecq@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Daping hospital</name>
        <address>
          <city>Chongqing</city>
          <zip>400042</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Daping Hospital, Third Military Medical University</name>
        <address>
          <city>Chongqing</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Degiuli M, Elmore U, De Luca R, De Nardi P, Tomatis M, Biondi A, Persiani R, Solaini L, Rizzo G, Soriero D, Cianflocca D, Milone M, Turri G, Rega D, Delrio P, Pedrazzani C, De Palma GD, Borghi F, Scabini S, Coco C, Cavaliere D, Simone M, Rosati R, Reddavid R; collaborators from the Italian Society of Surgical Oncology Colorectal Cancer Network Collaborative Group. Risk factors for anastomotic leakage after anterior resection for rectal cancer (RALAR study): A nationwide retrospective study of the Italian Society of Surgical Oncology Colorectal Cancer Network Collaborative Group. Colorectal Dis. 2022 Mar;24(3):264-276. doi: 10.1111/codi.15997. Epub 2021 Dec 6.</citation>
      <PMID>34816571</PMID>
    </reference>
    <reference>
      <citation>Zhao S, Zhang L, Gao F, Wu M, Zheng J, Bai L, Li F, Liu B, Pan Z, Liu J, Du K, Zhou X, Li C, Zhang A, Pu Z, Li Y, Feng B, Tong W. Transanal Drainage Tube Use for Preventing Anastomotic Leakage After Laparoscopic Low Anterior Resection in Patients With Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2021 Dec 1;156(12):1151-1158. doi: 10.1001/jamasurg.2021.4568.</citation>
      <PMID>34613330</PMID>
    </reference>
    <reference>
      <citation>Chapman WC Jr, Subramanian M, Jayarajan S, Makhdoom B, Mutch MG, Hunt S, Silviera ML, Glasgow SC, Olsen MA, Wise PE. First, Do No Harm: Rethinking Routine Diversion in Sphincter-Preserving Rectal Cancer Resection. J Am Coll Surg. 2019 Apr;228(4):547-556.e8. doi: 10.1016/j.jamcollsurg.2018.12.012. Epub 2019 Jan 9.</citation>
      <PMID>30639302</PMID>
    </reference>
    <reference>
      <citation>Kim JH, Kim S, Jung SH. Fecal diverting device for the substitution of defunctioning stoma: preliminary clinical study. Surg Endosc. 2019 Jan;33(1):333-340. doi: 10.1007/s00464-018-6389-4. Epub 2018 Aug 14.</citation>
      <PMID>30109482</PMID>
    </reference>
    <reference>
      <citation>Tsujinaka S, Suzuki H, Miura T, Sato Y, Shibata C. Obstructive and secretory complications of diverting ileostomy. World J Gastroenterol. 2022 Dec 21;28(47):6732-6742. doi: 10.3748/wjg.v28.i47.6732.</citation>
      <PMID>36620340</PMID>
    </reference>
    <reference>
      <citation>Murken DR, Bleier JIS. Ostomy-Related Complications. Clin Colon Rectal Surg. 2019 May;32(3):176-182. doi: 10.1055/s-0038-1676995. Epub 2019 Apr 2.</citation>
      <PMID>31061647</PMID>
    </reference>
    <reference>
      <citation>Huttner FJ, Probst P, Mihaljevic A, Contin P, Dorr-Harim C, Ulrich A, Schneider M, Buchler MW, Diener MK, Knebel P. Ghost ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer (DRKS00013997): protocol for a randomised controlled trial. BMJ Open. 2020 Oct 15;10(10):e038930. doi: 10.1136/bmjopen-2020-038930.</citation>
      <PMID>33060088</PMID>
    </reference>
    <reference>
      <citation>Miccini M, Amore Bonapasta S, Gregori M, Barillari P, Tocchi A. Ghost ileostomy: real and potential advantages. Am J Surg. 2010 Oct;200(4):e55-7. doi: 10.1016/j.amjsurg.2009.12.017.</citation>
      <PMID>20887836</PMID>
    </reference>
    <reference>
      <citation>Sacchi M, Legge PD, Picozzi P, Papa F, Giovanni CL, Greco L. Virtual ileostomy following TME and primary sphincter-saving reconstruction for rectal cancer. Hepatogastroenterology. 2007 Sep;54(78):1676-8.</citation>
      <PMID>18019692</PMID>
    </reference>
    <reference>
      <citation>Zenger S, Gurbuz B, Can U, Balik E, Yalti T, Bugra D. Comparative study between ghost ileostomy and defunctioning ileostomy in terms of morbidity and cost-effectiveness in low anterior resection for rectal cancer. Langenbecks Arch Surg. 2021 Mar;406(2):339-347. doi: 10.1007/s00423-021-02089-w. Epub 2021 Feb 4.</citation>
      <PMID>33537875</PMID>
    </reference>
    <reference>
      <citation>Baloyiannis I, Perivoliotis K, Diamantis A, Tzovaras G. Virtual ileostomy in elective colorectal surgery: a systematic review of the literature. Tech Coloproctol. 2020 Jan;24(1):23-31. doi: 10.1007/s10151-019-02127-2. Epub 2019 Dec 9.</citation>
      <PMID>31820192</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</investigator_affiliation>
      <investigator_full_name>fan li</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Virtual ileostomy</keyword>
    <keyword>Diverting ileostomy</keyword>
    <keyword>Rectal Neoplasms</keyword>
    <keyword>Rectosigmoid junction</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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985252
  org study id: GS-RCT
  nct id: NCT05985252
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed at comparing the Comprehensive Complication Index (CCI), readmission rates,
        postoperative hospitalization days, duration of bearing the stoma (months), hospitalization
        costs, the number of hospitalizations with ghost ileostomy versus conventional loop ileostomy
        after low anterior resection for rectal cancer.
  Diverting ileostomy (DI) is a common procedure performed in patients undergoing low anterior
        resection for rectal cancer to protect the anastomosis and reduce the risk of complications.
        Although DI remains one of the most common methods used in clinical practice to prevent
        anastomotic leakage, there is still considerable debate in clinical practice about whether to
        perform a routine ileostomy. Despite temporary ileostomy fecal diversion can reduce the
        development of abdominal abscesses, wound inflammation, peritonitis, and sepsis after the
        occurrence of AL, however, it not only failed to reduce the incidence of AL but significantly
        increased the risk of non-elective readmissions and reinterventions as well as higher total
        costs. Meanwhile, stoma significantly increase the risk of stoma-related complication such as
        small bowel obstruction, postoperative ileus, dehydration from high-output stoma culminating
        in acute kidney injury, electrolyte imbalance, stoma stenosis/ necrosis, parastomal hernia,
        peristomal abscess, and fistula, etc.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Calculation postoperative of the Comprehensive Complication Index (CCI) for each patient
  time frame: An average of 1 year from the date of low anterior resection for rectal cancer until the date of when the patient's condition is stabilized without complications
  description: The Comprehensive Complication Index (CCI)summarises all postoperative complications based on the established Clavien-Dindo classification (ranging from mild complications not leading to a deviation from the normal clinical course (grade I) up to postoperative death (grade V)) at an individual patient level according to their grade of severity.
  measure: Postoperative hospitalization days
  time frame: Through study completion, an average of 1 year
  description: Patients in the virtual stoma group who did not have a second surgery due to complications recorded days of postoperative hospitalization after low anterior resection for rectal cancer, if the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record days of postoperative hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.
  measure: Readmission rates
  time frame: Through study completion, an average of 1 year
  description: Patients in the virtual stoma group who did not have a second surgery due to complications recorded the number of hospitalization after low anterior resection for rectal cancer. If the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the number of hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.
  measure: The number of hospitalizations
  time frame: Through study completion, an average of 1 year
  description: Patients in the virtual stoma group who did not have a second surgery due to complications recorded the number of hospitalization after low anterior resection for rectal cancer. If the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the number of hospitalization due to complications and/or reoperation since the data of low anterior resection for rectal cancer.
  measure: Duration of bearing the stoma (months)
  time frame: Through study completion, an average of 1 year
  description: If the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the duration of bearing the stoma since the data of surgery of diverting ileostomy.
  measure: First hospitalization costs
  time frame: During hospitalization,approximately 7 days
  description: Patient hospitalization costs for radical resection of rectal cancer.
  measure: Total hospitalization costs
  time frame: Through study completion, an average of 1 year
  description: Patients in the virtual stoma group who did not have a second surgery due to complications recorded the costs after low anterior resection for rectal cancer, if the virtual stoma group required bedside or secondary surgery for diverting ileostomy due to complications and all patients in the diverting ileostomy group required reoperation for stoma reversal, record the costs due to complications and reoperation since the data of low anterior resection for rectal cancer.
  measure: Whether patients undergo terminal ostomy after low anterior resection for rectal cancer.
  time frame: Through study completion, an average of 1 year
  description: Hartmann's procedure or for example, abdominoperineal extirpation
  measure: Patients with stoma (terminal/loop) at 6 months after initial surgery
  time frame: 6 months from the date of low anterior resection for rectal cancer
  description: Patients carrying stoma 6 months after low anterior resection for rectal cancer.
  measure: The number of participants with virtual ileostomy converted to diverting ileostomy
  time frame: Through study completion, an average of 1 year
  description: The virtual stoma required bedside or secondary surgery for diverting ileostomy due to complications.
  measure: The number of patients who required secondary abdominal surgery under general anesthesia due to complications
  time frame: Through study completion, an average of 1 year
  description: Patient undergoes second abdominal surgery for complications after first surgery
  measure: Ghost ileostomy remove time
  time frame: During hospitalization,approximately 7 days
  description: Duration of days from the date of radical resection of rectal cancer to virtual stoma removed.
  measure: The number of patients with complications after low anterior resection for rectal cancer
  time frame: Through study completion, an average of 1 year
  description: Abdominal abscess,Anastomotic bleeding,Pelvic infection,Surgical incision infection, Peritonitis,Interventional drainage ,ileostomy wounds/abscesses/edema/dermatitis/ ulcers,Parastomal hernia ,Stoma prolapse,Anastomotic separation/poor healing, Anastomotic stenosis,Anastomotic leakage,Bowel obstruction,Anastomotic bowel necrosis ,Wound dehiscence / bleeding / sinus tract / abscess/fat liquefaction,Acute kidney injury ,Dehydration/output >1500 mL/day,Converted to permanent ileostomy,Intestinal fistula,Incisional hernia ,fecal incontinence.
  measure: Adjuvant chemotherapy in patients after low anterior resection for rectal cancer.
  time frame: 6 months from the date of low anterior resection for rectal cancer
  description: Whether the patient has completed chemotherapy.
  arm group label: Virtual ileostomy
  arm group type: Experimental
  description: Laparoscopic or robotic surgery with virtual ileostomy
  arm group label: Diverting ileostomy
  arm group type: Active Comparator
  description: Laparoscopic or robotic surgery with diverting ileostomy
  intervention type: Procedure
  intervention name: Virtual ileostomy
  description: Laparoscopic or robotic surgery with virtual ileostomy
  arm group label: Virtual ileostomy
  intervention type: Procedure
  intervention name: Diverting ileostomy
  description: Laparoscopic or robotic surgery with diverting ileostomy
  arm group label: Diverting ileostomy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: fan li
  role: Principal Investigator
  affiliation: Daping Hospital, Third Military Medical University
  last name: fan li
  phone: +86 023 68757958
  email: levinecq@163.com
  facility: 
  facility: 
  country: China
  citation: Degiuli M, Elmore U, De Luca R, De Nardi P, Tomatis M, Biondi A, Persiani R, Solaini L, Rizzo G, Soriero D, Cianflocca D, Milone M, Turri G, Rega D, Delrio P, Pedrazzani C, De Palma GD, Borghi F, Scabini S, Coco C, Cavaliere D, Simone M, Rosati R, Reddavid R; collaborators from the Italian Society of Surgical Oncology Colorectal Cancer Network Collaborative Group. Risk factors for anastomotic leakage after anterior resection for rectal cancer (RALAR study): A nationwide retrospective study of the Italian Society of Surgical Oncology Colorectal Cancer Network Collaborative Group. Colorectal Dis. 2022 Mar;24(3):264-276. doi: 10.1111/codi.15997. Epub 2021 Dec 6.
  PMID: 34816571
  citation: Zhao S, Zhang L, Gao F, Wu M, Zheng J, Bai L, Li F, Liu B, Pan Z, Liu J, Du K, Zhou X, Li C, Zhang A, Pu Z, Li Y, Feng B, Tong W. Transanal Drainage Tube Use for Preventing Anastomotic Leakage After Laparoscopic Low Anterior Resection in Patients With Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2021 Dec 1;156(12):1151-1158. doi: 10.1001/jamasurg.2021.4568.
  PMID: 34613330
  citation: Chapman WC Jr, Subramanian M, Jayarajan S, Makhdoom B, Mutch MG, Hunt S, Silviera ML, Glasgow SC, Olsen MA, Wise PE. First, Do No Harm: Rethinking Routine Diversion in Sphincter-Preserving Rectal Cancer Resection. J Am Coll Surg. 2019 Apr;228(4):547-556.e8. doi: 10.1016/j.jamcollsurg.2018.12.012. Epub 2019 Jan 9.
  PMID: 30639302
  citation: Kim JH, Kim S, Jung SH. Fecal diverting device for the substitution of defunctioning stoma: preliminary clinical study. Surg Endosc. 2019 Jan;33(1):333-340. doi: 10.1007/s00464-018-6389-4. Epub 2018 Aug 14.
  PMID: 30109482
  citation: Tsujinaka S, Suzuki H, Miura T, Sato Y, Shibata C. Obstructive and secretory complications of diverting ileostomy. World J Gastroenterol. 2022 Dec 21;28(47):6732-6742. doi: 10.3748/wjg.v28.i47.6732.
  PMID: 36620340
  citation: Murken DR, Bleier JIS. Ostomy-Related Complications. Clin Colon Rectal Surg. 2019 May;32(3):176-182. doi: 10.1055/s-0038-1676995. Epub 2019 Apr 2.
  PMID: 31061647
  citation: Huttner FJ, Probst P, Mihaljevic A, Contin P, Dorr-Harim C, Ulrich A, Schneider M, Buchler MW, Diener MK, Knebel P. Ghost ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer (DRKS00013997): protocol for a randomised controlled trial. BMJ Open. 2020 Oct 15;10(10):e038930. doi: 10.1136/bmjopen-2020-038930.
  PMID: 33060088
  citation: Miccini M, Amore Bonapasta S, Gregori M, Barillari P, Tocchi A. Ghost ileostomy: real and potential advantages. Am J Surg. 2010 Oct;200(4):e55-7. doi: 10.1016/j.amjsurg.2009.12.017.
  PMID: 20887836
  citation: Sacchi M, Legge PD, Picozzi P, Papa F, Giovanni CL, Greco L. Virtual ileostomy following TME and primary sphincter-saving reconstruction for rectal cancer. Hepatogastroenterology. 2007 Sep;54(78):1676-8.
  PMID: 18019692
  citation: Zenger S, Gurbuz B, Can U, Balik E, Yalti T, Bugra D. Comparative study between ghost ileostomy and defunctioning ileostomy in terms of morbidity and cost-effectiveness in low anterior resection for rectal cancer. Langenbecks Arch Surg. 2021 Mar;406(2):339-347. doi: 10.1007/s00423-021-02089-w. Epub 2021 Feb 4.
  PMID: 33537875
  citation: Baloyiannis I, Perivoliotis K, Diamantis A, Tzovaras G. Virtual ileostomy in elective colorectal surgery: a systematic review of the literature. Tech Coloproctol. 2020 Jan;24(1):23-31. doi: 10.1007/s10151-019-02127-2. Epub 2019 Dec 9.
  PMID: 31820192
  responsible party type: Principal Investigator
  investigator affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  investigator full name: fan li
  investigator title: Professor
  mesh term: Rectal Neoplasms
  sharing ipd: No