MATRAC: Abdominal Massage to Prevent Postoperative Ileus After Colorectal Surgery

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Recruiting
CT.gov ID
NCT04462705
Collaborator
(none)
36
1
2
12.7
2.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Usual physiotherapeutic intervention and Abdominal Massage
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Abdominal Massage to Prevent Postoperative Ileus as Part of an Enhanced Recovery Program After Colorectal Surgery
Actual Study Start Date :
Aug 18, 2020
Anticipated Primary Completion Date :
Jul 9, 2021
Anticipated Study Completion Date :
Sep 9, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Usual physiotherapeutic intervention

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

Procedure: Usual physiotherapeutic intervention and Abdominal Massage
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.

Experimental: abdominal massage and usual physiotherapeutic intervention

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.

Procedure: Usual physiotherapeutic intervention and Abdominal Massage
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.

Outcome Measures

Primary Outcome Measures

  1. Evaluate the effect of abdominal massage on time to normal bowel function after colorectal surgery [through study completion, 30 days]

    Time to normal bowel function

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patients >18years (homme et femme de plus de 18 ans)

  • Elective Patients undergoing colorectal surgery with intestinal anastomosis (Colectomy, Anterior Resection, intestinal resection or stoma closure) without protective stoma creation in an Enhanced Recovery After Surgery Program

  • Able to give the consent

  • Affiliated to Social Security

Exclusion Criteria:
  • Mental disorders

  • Cutaneous infection on the abdomen

  • Pregrancy and breast feeding

  • Patients unable to give their free consent (incarcerated, legal protection measures)

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHu grenoble alpes Grenoble France

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

  • Principal Investigator: Bertrand TRILLING, MD, PhD, BTrilling@chu-grenoble.fr

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT04462705
Other Study ID Numbers:
  • 38RC20.021
First Posted:
Jul 8, 2020
Last Update Posted:
Apr 30, 2021
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 30, 2021