<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/NCT03754907</url>
  </required_header>
  <id_info>
    <org_study_id>Zunyi Medical University</org_study_id>
    <nct_id>NCT03754907</nct_id>
  </id_info>
  <brief_title>Stapled Anastomosis Versus Hand-sewn for Neonate With Intestinal Atresia</brief_title>
  <acronym>SAVSHA</acronym>
  <official_title>Comparing Stapled Anastomosis With Hand-sewn in Neonate With Intestinal Atresia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zunyi Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zunyi Medical College</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>
      Neonatal intestinal atresia is the most difficult disease to apply stapled anastomosis.&#xD;
      However, there are no high-quality clinical trial to verify its effectiveness. Therefore, the&#xD;
      investigators compared the outcomes of stapled and hand-sewn anastomosis in neonate with&#xD;
      intestinal atresia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intestinal anastomosis in neonates with intestinal atresia has traditionally been performed&#xD;
      using the hand-sewn end-to-end approach. After the introduction of stapled functional&#xD;
      end-to-end anastomosis (FEEA) in neonates and infants by Powell in 1995, the procedure is&#xD;
      gradually being accepted among pediatric surgeons. When treating intestinal atresia, great&#xD;
      discrepancy between diameters of the proximal and distal intestine caused by disuse atrophy&#xD;
      are often observed, which may cause difficulties and complications. To overcome size&#xD;
      discrepancy, proficiency in performing anastomosis is required when using hand-sewn&#xD;
      techniques. in theory, stapled functional end-to-end anastomosis does not require a special&#xD;
      technique and does not impair the passage of intestinal contents immediately after completion&#xD;
      because the side-to-side nature of the procedure retains the unique diameter of the target&#xD;
      intestine and preserves patency. Stapled side-to-side functional end-to-end intestinal&#xD;
      anastomosis is a potentially useful technique that is not affected by intestinal size&#xD;
      discrepancy and does not require specialized surgical experience.To date, there have been a&#xD;
      few studies about the safety and efficacy of stapled anastomosis in neonates and infants,&#xD;
      which reported the efficacy of stapled over hand-sewn anastomosis, including shorter&#xD;
      operative time, time to full feeding and hospitalization, and no difference in adverse&#xD;
      outcomes between both types of anastomoses. These studies compared the clinical outcomes in&#xD;
      neonates and infants. However,there are no high-quality clinical trials to verify its&#xD;
      effectiveness. Therefore, the investigators compared the outcomes of stapled FEEA and&#xD;
      hand-sewn anastomosis in neonate with intestinal atresia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2020</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment success rate</measure>
    <time_frame>1 year</time_frame>
    <description>Treatment success rate is defined as a patient successfully undergoing two respectively operative methods in two groups , resulting in discharge from the hospital without the need for reoperation intervention and no complication happened during a minimum follow-up of 1 year (treatment efficacy).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operative time(minute)</measure>
    <time_frame>1 year</time_frame>
    <description>the operative time(minute) in two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated blood loss(ml)</measure>
    <time_frame>1 year</time_frame>
    <description>the surgeon estimated blood loss(ml) in two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to initial oral feeding</measure>
    <time_frame>1 year</time_frame>
    <description>the time patients from operation to the first oral feeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to full oral feeding</measure>
    <time_frame>1 year</time_frame>
    <description>the time patients from operation to the full oral feeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anastomotic leakage and stricture</measure>
    <time_frame>1year</time_frame>
    <description>the incidence of complications include the anastomotic leakage and stricture between stapled anastomosis and hand-sewn anastomosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ileus</measure>
    <time_frame>1 year</time_frame>
    <description>the incidence of ileus after operations 1 year in two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>volvulus</measure>
    <time_frame>1 year</time_frame>
    <description>the incidence of Volvulus with adhesive bands and malrotation because of anastomotic dilatation in two groups after operation 1year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>reoperation</measure>
    <time_frame>1 year</time_frame>
    <description>the incidence of complication requiring reoperation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>classification</measure>
    <time_frame>3 year</time_frame>
    <description>counted the classification of intestinal atresia</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Intestinal Atresia</condition>
  <condition>Anastomotic Complication</condition>
  <arm_group>
    <arm_group_label>stapled anastomosis group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following the first side-to-side anastomosis at the antimesenteric border in both intestinal limbs, the staple lines are oversewn to reinforce the crotch. Thereafter, the stapler is again fired across the joined intestinal limbs to close the enterotomies. The suture line of the side-to-side anastomosis should not overlap, and the staple lines are oversewn to reinforce the double-stapled areas.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hand-sewn anastomosis group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients chose HA group will performed in an end-to-end manner using absorbable suture material.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endocutter stapler</intervention_name>
    <description>Endocutter ETS 35, ETS Flex 45 stapler, and the Echelon Flex Powered ENDOPATH Stapler with 2.5- or 3.5-mm staples (Johnson &amp; Johnson K.K., Tokyo, Japan)</description>
    <arm_group_label>stapled anastomosis group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>suture material</intervention_name>
    <description>absorbable suture material is used to perform hand-sewn anastomosis in an end-to-end manner.</description>
    <arm_group_label>hand-sewn anastomosis group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients were eligible if they were between 1 day and 30 days of age, and if they&#xD;
             suffered from intestinal atresia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  These patients were complicated with intestinal perforation and peritonitis,&#xD;
             instability of vital signs.&#xD;
&#xD;
          -  Stapled anastomosis could not be performed when the intestinal lumen could not admit a&#xD;
             22-Fr soft catheter.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>30 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuanmei Liu</last_name>
    <role>Study Director</role>
    <affiliation>Zunyi Medical College</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>zebing zheng, MD</last_name>
    <phone>18285269257</phone>
    <email>zebing1988@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yuanmei Liu</last_name>
    <phone>+868518609329</phone>
    <email>yuanmei116@aliyun.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Affiliated Hospital of Zunyi Medical University</name>
      <address>
        <city>Zunyi</city>
        <state>Guizhou</state>
        <zip>563000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rongruo Liao</last_name>
      <phone>+868518608225</phone>
      <email>zzbhaofan@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Sato K, Uchida H, Tanaka Y, Takazawa S, Jimbo T, Deie K. Stapled intestinal anastomosis is a simple and reliable method for management of intestinal caliber discrepancy in children. Pediatr Surg Int. 2012 Sep;28(9):893-8. doi: 10.1007/s00383-012-3146-y.</citation>
    <PMID>22864546</PMID>
  </reference>
  <reference>
    <citation>Amano H, Tanaka Y, Tainaka T, Hinoki A, Kawashima H, Kakihara T, Morita K, Uchida H. The impact of body weight on stapled anastomosis in pediatric patients. J Pediatr Surg. 2018 Oct;53(10):2036-2040. doi: 10.1016/j.jpedsurg.2018.04.030. Epub 2018 Apr 26.</citation>
    <PMID>29792281</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zunyi Medical College</investigator_affiliation>
    <investigator_full_name>zebing Zheng</investigator_full_name>
    <investigator_title>pediatric surgery</investigator_title>
  </responsible_party>
  <keyword>stapled anastomosis</keyword>
  <keyword>hand-sewn anastomosis</keyword>
  <keyword>intestinal atresia</keyword>
  <keyword>neonate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Atresia</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/NCT03754907
org study id: Zunyi Medical University
nct id: NCT03754907
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Neonatal intestinal atresia is the most difficult disease to apply stapled anastomosis.
      However, there are no high-quality clinical trial to verify its effectiveness. Therefore, the
      investigators compared the outcomes of stapled and hand-sewn anastomosis in neonate with
      intestinal atresia.
Intestinal anastomosis in neonates with intestinal atresia has traditionally been performed
      using the hand-sewn end-to-end approach. After the introduction of stapled functional
      end-to-end anastomosis (FEEA) in neonates and infants by Powell in 1995, the procedure is
      gradually being accepted among pediatric surgeons. When treating intestinal atresia, great
      discrepancy between diameters of the proximal and distal intestine caused by disuse atrophy
      are often observed, which may cause difficulties and complications. To overcome size
      discrepancy, proficiency in performing anastomosis is required when using hand-sewn
      techniques. in theory, stapled functional end-to-end anastomosis does not require a special
      technique and does not impair the passage of intestinal contents immediately after completion
      because the side-to-side nature of the procedure retains the unique diameter of the target
      intestine and preserves patency. Stapled side-to-side functional end-to-end intestinal
      anastomosis is a potentially useful technique that is not affected by intestinal size
      discrepancy and does not require specialized surgical experience.To date, there have been a
      few studies about the safety and efficacy of stapled anastomosis in neonates and infants,
      which reported the efficacy of stapled over hand-sewn anastomosis, including shorter
      operative time, time to full feeding and hospitalization, and no difference in adverse
      outcomes between both types of anastomoses. These studies compared the clinical outcomes in
      neonates and infants. However,there are no high-quality clinical trials to verify its
      effectiveness. Therefore, the investigators compared the outcomes of stapled FEEA and
      hand-sewn anastomosis in neonate with intestinal atresia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Treatment success rate
time frame: 1 year
description: Treatment success rate is defined as a patient successfully undergoing two respectively operative methods in two groups , resulting in discharge from the hospital without the need for reoperation intervention and no complication happened during a minimum follow-up of 1 year (treatment efficacy).
measure: Operative time(minute)
time frame: 1 year
description: the operative time(minute) in two groups
measure: Estimated blood loss(ml)
time frame: 1 year
description: the surgeon estimated blood loss(ml) in two groups
measure: Time to initial oral feeding
time frame: 1 year
description: the time patients from operation to the first oral feeding.
measure: Time to full oral feeding
time frame: 1 year
description: the time patients from operation to the full oral feeding.
measure: anastomotic leakage and stricture
time frame: 1year
description: the incidence of complications include the anastomotic leakage and stricture between stapled anastomosis and hand-sewn anastomosis.
measure: ileus
time frame: 1 year
description: the incidence of ileus after operations 1 year in two groups
measure: volvulus
time frame: 1 year
description: the incidence of Volvulus with adhesive bands and malrotation because of anastomotic dilatation in two groups after operation 1year
measure: reoperation
time frame: 1 year
description: the incidence of complication requiring reoperation
measure: classification
time frame: 3 year
description: counted the classification of intestinal atresia
arm group label: stapled anastomosis group
arm group type: Experimental
description: Following the first side-to-side anastomosis at the antimesenteric border in both intestinal limbs, the staple lines are oversewn to reinforce the crotch. Thereafter, the stapler is again fired across the joined intestinal limbs to close the enterotomies. The suture line of the side-to-side anastomosis should not overlap, and the staple lines are oversewn to reinforce the double-stapled areas.
arm group label: hand-sewn anastomosis group
arm group type: Active Comparator
description: Patients chose HA group will performed in an end-to-end manner using absorbable suture material.
intervention type: Procedure
intervention name: Endocutter stapler
description: Endocutter ETS 35, ETS Flex 45 stapler, and the Echelon Flex Powered ENDOPATH Stapler with 2.5- or 3.5-mm staples (Johnson & Johnson K.K., Tokyo, Japan)
arm group label: stapled anastomosis group
intervention type: Procedure
intervention name: suture material
description: absorbable suture material is used to perform hand-sewn anastomosis in an end-to-end manner.
arm group label: hand-sewn anastomosis group
criteria: 
gender: All
minimum age: 1 Day
maximum age: 30 Days
healthy volunteers: No
last name: Yuanmei Liu
role: Study Director
affiliation: Zunyi Medical College
last name: zebing zheng, MD
phone: 18285269257
email: zebing1988@sina.com
last name: Yuanmei Liu
phone: +868518609329
email: yuanmei116@aliyun.com
facility: 
status: Recruiting
contact: 
country: China
citation: Sato K, Uchida H, Tanaka Y, Takazawa S, Jimbo T, Deie K. Stapled intestinal anastomosis is a simple and reliable method for management of intestinal caliber discrepancy in children. Pediatr Surg Int. 2012 Sep;28(9):893-8. doi: 10.1007/s00383-012-3146-y.
PMID: 22864546
citation: Amano H, Tanaka Y, Tainaka T, Hinoki A, Kawashima H, Kakihara T, Morita K, Uchida H. The impact of body weight on stapled anastomosis in pediatric patients. J Pediatr Surg. 2018 Oct;53(10):2036-2040. doi: 10.1016/j.jpedsurg.2018.04.030. Epub 2018 Apr 26.
PMID: 29792281
responsible party type: Principal Investigator
investigator affiliation: Zunyi Medical College
investigator full name: zebing Zheng
investigator title: pediatric surgery
mesh term: Intestinal Atresia