<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/NCT04462705</url>
  </required_header>
  <id_info>
    <org_study_id>38RC20.021</org_study_id>
    <nct_id>NCT04462705</nct_id>
  </id_info>
  <brief_title>Abdominal Massage to Prevent Postoperative Ileus After Colorectal Surgery</brief_title>
  <acronym>MATRAC</acronym>
  <official_title>Abdominal Massage to Prevent Postoperative Ileus as Part of an Enhanced Recovery Program After Colorectal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</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>
      Post operative ileus refers to an disrupt in normal gastrointestinal motility responsible of&#xD;
      nausea and vomiting. It occurs in about 15-20% of colorectal surgeries. Some preventive&#xD;
      measures have been included in the Enhanced Recovery After Surgery Program such as early&#xD;
      mobilisation and enteral feeding or minimal invasive approach.&#xD;
&#xD;
      Abdominal massage is not widely applied amongst general surgery team and is not part of the&#xD;
      recommendation. This technique refers to profound manœuvrers of visceras through abdominal&#xD;
      palpation and breathing, and has been used as part of the local protocol of Grenoble Alps&#xD;
      University Hospital for many years with satisfactory results. No complications have been&#xD;
      reported.&#xD;
&#xD;
      Various studies have evaluated the value of physiotherapy and massage for resumption of&#xD;
      normal bowel function. A study from Rouen University Hospital demonstrated that a mechanical&#xD;
      stress to the cuteaneous tissue by LPG Cellu M50® machine would reduce pain and lower the&#xD;
      time to first flatus. Similar results were obtained after Cardiac surgery. In a preclinical&#xD;
      study on operated rats, abdominal massage also improved normal bowel function recovery.&#xD;
&#xD;
      Physiotherapist plays a key role in RAC. Their action on respiratory function (movement of&#xD;
      diaphragm) and musculoskeletal system (early walking) allows a faster recovery and a&#xD;
      reduction of time of hospitalization. Even though the results on time to first flatus and&#xD;
      anxiety seem interesting, Deep abdominal massage has never been evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2020</start_date>
  <completion_date type="Actual">September 9, 2021</completion_date>
  <primary_completion_date type="Actual">July 9, 2021</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the effect of abdominal massage on time to normal bowel function after colorectal surgery</measure>
    <time_frame>through study completion, 30 days</time_frame>
    <description>Time to normal bowel function</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Colorectal Surgery</condition>
  <arm_group>
    <arm_group_label>Usual physiotherapeutic intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the usual physiotherapeutic intervention (respiratory and walking exercices). Each patients will be treated following the ERAS Guideline.&#xD;
- At D + 1 post-surgical:&#xD;
- First lift with verticalization.&#xD;
- A session with the Cliniflo® in a seated position.&#xD;
- Walk at least 100 m with the help of the physiotherapist.&#xD;
At- D+2 and D+3 post-surgical Same session as on D+1 with progressive increase in the walking perimeter. Add up and down stairs on D+ 3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>abdominal massage and usual physiotherapeutic intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the usual physiotherapeutic intervention (respiratory and walking exercices). Each patients will be treated following the ERAS Guideline.&#xD;
- At D + 1post-surgical:&#xD;
- First lift with verticalization.&#xD;
- A session with the Cliniflo® in a seated position.&#xD;
- Walk at least 100 m with the help of the physiotherapist.&#xD;
At- D + 2 and D + 3 post-surgical Same session as on D + 1 with progressive increase in the walking perimeter. Add up and down stairs on D+ 3&#xD;
In this experimental arm, a abdominal massage will be performed in addition to the usual physiotherapeutic intervention (respiratory and walking exercices).&#xD;
The sessions take place on D+1, D+2 and D+3 post-surgical The first session is performed at least 20 hours after surgery (incision begins) Never within an hour of a meal. The session is timed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Usual physiotherapeutic intervention and Abdominal Massage</intervention_name>
    <description>Abdominal massage is not widely applied amongst general surgery team and is not part of the recommendation. This technique refers to profound manœuvrers of visceras through abdominal palpation and breathing, and has been used as part of the local protocol of Grenoble Alps University Hospital for many years with satisfactory results. No complications have been reported.</description>
    <arm_group_label>Usual physiotherapeutic intervention</arm_group_label>
    <arm_group_label>abdominal massage and usual physiotherapeutic intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients &gt;18years (homme et femme de plus de 18 ans)&#xD;
&#xD;
          -  Elective Patients undergoing colorectal surgery with intestinal anastomosis&#xD;
             (Colectomy, Anterior Resection, intestinal resection or stoma closure) without&#xD;
             protective stoma creation in an Enhanced Recovery After Surgery Program&#xD;
&#xD;
          -  Able to give the consent&#xD;
&#xD;
          -  Affiliated to Social Security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mental disorders&#xD;
&#xD;
          -  Cutaneous infection on the abdomen&#xD;
&#xD;
          -  Pregrancy and breast feeding&#xD;
&#xD;
          -  Patients unable to give their free consent (incarcerated, legal protection measures)&#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>Bertrand TRILLING, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BTrilling@chu-grenoble.fr</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHu grenoble alpes</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Le Blanc-Louvry I, Costaglioli B, Boulon C, Leroi AM, Ducrotte P. Does mechanical massage of the abdominal wall after colectomy reduce postoperative pain and shorten the duration of ileus? Results of a randomized study. J Gastrointest Surg. 2002 Jan-Feb;6(1):43-9. doi: 10.1016/s1091-255x(01)00009-9.</citation>
    <PMID>11986017</PMID>
  </reference>
  <reference>
    <citation>Bauer BA, Cutshall SM, Wentworth LJ, Engen D, Messner PK, Wood CM, Brekke KM, Kelly RF, Sundt TM 3rd. Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study. Complement Ther Clin Pract. 2010 May;16(2):70-5. doi: 10.1016/j.ctcp.2009.06.012. Epub 2009 Jul 14.</citation>
    <PMID>20347836</PMID>
  </reference>
  <reference>
    <citation>Dreyer NE, Cutshall SM, Huebner M, Foss DM, Lovely JK, Bauer BA, Cima RR. Effect of massage therapy on pain, anxiety, relaxation, and tension after colorectal surgery: A randomized study. Complement Ther Clin Pract. 2015 Aug;21(3):154-9. doi: 10.1016/j.ctcp.2015.06.004. Epub 2015 Jun 12.</citation>
    <PMID>26256133</PMID>
  </reference>
  <reference>
    <citation>Chapelle SL, Bove GM. Visceral massage reduces postoperative ileus in a rat model. J Bodyw Mov Ther. 2013 Jan;17(1):83-8. doi: 10.1016/j.jbmt.2012.05.004. Epub 2012 Aug 12.</citation>
    <PMID>23294688</PMID>
  </reference>
  <reference>
    <citation>Navalgund A, Axelrod S, Axelrod L, Singhal S, Tran K, Legha P, Triadafilopoulos G. Colon Myoelectric Activity Measured After Open Abdominal Surgery with a Noninvasive Wireless Patch System Predicts Time to First Flatus. J Gastrointest Surg. 2019 May;23(5):982-989. doi: 10.1007/s11605-018-4030-4. Epub 2018 Nov 2.</citation>
    <PMID>30390183</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>February 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>September 20, 2022</last_update_submitted>
  <last_update_submitted_qc>September 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04462705
org study id: 38RC20.021
nct id: NCT04462705
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Post operative ileus refers to an disrupt in normal gastrointestinal motility responsible of
      nausea and vomiting. It occurs in about 15-20% of colorectal surgeries. Some preventive
      measures have been included in the Enhanced Recovery After Surgery Program such as early
      mobilisation and enteral feeding or minimal invasive approach.

      Abdominal massage is not widely applied amongst general surgery team and is not part of the
      recommendation. This technique refers to profound manœuvrers of visceras through abdominal
      palpation and breathing, and has been used as part of the local protocol of Grenoble Alps
      University Hospital for many years with satisfactory results. No complications have been
      reported.

      Various studies have evaluated the value of physiotherapy and massage for resumption of
      normal bowel function. A study from Rouen University Hospital demonstrated that a mechanical
      stress to the cuteaneous tissue by LPG Cellu M50® machine would reduce pain and lower the
      time to first flatus. Similar results were obtained after Cardiac surgery. In a preclinical
      study on operated rats, abdominal massage also improved normal bowel function recovery.

      Physiotherapist plays a key role in RAC. Their action on respiratory function (movement of
      diaphragm) and musculoskeletal system (early walking) allows a faster recovery and a
      reduction of time of hospitalization. Even though the results on time to first flatus and
      anxiety seem interesting, Deep abdominal massage has never been evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Evaluate the effect of abdominal massage on time to normal bowel function after colorectal surgery
time frame: through study completion, 30 days
description: Time to normal bowel function
arm group label: Usual physiotherapeutic intervention
arm group type: Active Comparator
description: the usual physiotherapeutic intervention (respiratory and walking exercices). Each patients will be treated following the ERAS Guideline.
- At D + 1 post-surgical:
- First lift with verticalization.
- A session with the Cliniflo® in a seated position.
- Walk at least 100 m with the help of the physiotherapist.
At- D+2 and D+3 post-surgical Same session as on D+1 with progressive increase in the walking perimeter. Add up and down stairs on D+ 3
arm group label: abdominal massage and usual physiotherapeutic intervention
arm group type: Experimental
description: the usual physiotherapeutic intervention (respiratory and walking exercices). Each patients will be treated following the ERAS Guideline.
- At D + 1post-surgical:
- First lift with verticalization.
- A session with the Cliniflo® in a seated position.
- Walk at least 100 m with the help of the physiotherapist.
At- D + 2 and D + 3 post-surgical Same session as on D + 1 with progressive increase in the walking perimeter. Add up and down stairs on D+ 3
In this experimental arm, a abdominal massage will be performed in addition to the usual physiotherapeutic intervention (respiratory and walking exercices).
The sessions take place on D+1, D+2 and D+3 post-surgical The first session is performed at least 20 hours after surgery (incision begins) Never within an hour of a meal. The session is timed.
intervention type: Procedure
intervention name: Usual physiotherapeutic intervention and Abdominal Massage
description: Abdominal massage is not widely applied amongst general surgery team and is not part of the recommendation. This technique refers to profound manœuvrers of visceras through abdominal palpation and breathing, and has been used as part of the local protocol of Grenoble Alps University Hospital for many years with satisfactory results. No complications have been reported.
arm group label: Usual physiotherapeutic intervention
arm group label: abdominal massage and usual physiotherapeutic intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bertrand TRILLING, MD, PhD
role: Principal Investigator
affiliation: BTrilling@chu-grenoble.fr
facility: 
country: France
citation: Le Blanc-Louvry I, Costaglioli B, Boulon C, Leroi AM, Ducrotte P. Does mechanical massage of the abdominal wall after colectomy reduce postoperative pain and shorten the duration of ileus? Results of a randomized study. J Gastrointest Surg. 2002 Jan-Feb;6(1):43-9. doi: 10.1016/s1091-255x(01)00009-9.
PMID: 11986017
citation: Bauer BA, Cutshall SM, Wentworth LJ, Engen D, Messner PK, Wood CM, Brekke KM, Kelly RF, Sundt TM 3rd. Effect of massage therapy on pain, anxiety, and tension after cardiac surgery: a randomized study. Complement Ther Clin Pract. 2010 May;16(2):70-5. doi: 10.1016/j.ctcp.2009.06.012. Epub 2009 Jul 14.
PMID: 20347836
citation: Dreyer NE, Cutshall SM, Huebner M, Foss DM, Lovely JK, Bauer BA, Cima RR. Effect of massage therapy on pain, anxiety, relaxation, and tension after colorectal surgery: A randomized study. Complement Ther Clin Pract. 2015 Aug;21(3):154-9. doi: 10.1016/j.ctcp.2015.06.004. Epub 2015 Jun 12.
PMID: 26256133
citation: Chapelle SL, Bove GM. Visceral massage reduces postoperative ileus in a rat model. J Bodyw Mov Ther. 2013 Jan;17(1):83-8. doi: 10.1016/j.jbmt.2012.05.004. Epub 2012 Aug 12.
PMID: 23294688
citation: Navalgund A, Axelrod S, Axelrod L, Singhal S, Tran K, Legha P, Triadafilopoulos G. Colon Myoelectric Activity Measured After Open Abdominal Surgery with a Noninvasive Wireless Patch System Predicts Time to First Flatus. J Gastrointest Surg. 2019 May;23(5):982-989. doi: 10.1007/s11605-018-4030-4. Epub 2018 Nov 2.
PMID: 30390183
responsible party type: Sponsor