NCT04462705

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

August 18, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2021

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

11 months

First QC Date

February 20, 2020

Last Update Submit

September 20, 2022

Conditions

Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effect of abdominal massage on time to normal bowel function after colorectal surgery

    Time to normal bowel function

    through study completion, 30 days

Study Arms (2)

Usual physiotherapeutic intervention

ACTIVE COMPARATOR

the usual physiotherapeutic intervention (respiratory and walking exercices). Each patients will be treated following the ERAS Guideline. \- At D + 1 post-surgical: 1. \- First lift with verticalization. 2. \- A session with the Cliniflo® in a seated position. 3. \- 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 and usual physiotherapeutic intervention

EXPERIMENTAL

the usual physiotherapeutic intervention (respiratory and walking exercices). Each patients will be treated following the ERAS Guideline. \- At D + 1post-surgical: 1. \- First lift with verticalization. 2. \- A session with the Cliniflo® in a seated position. 3. \- 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

Interventions

Usual physiotherapeutic intervention and Abdominal MassagePROCEDURE

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.

Usual physiotherapeutic interventionabdominal massage and usual physiotherapeutic intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Mental disorders
  • Cutaneous infection on the abdomen
  • Pregrancy and breast feeding
  • Patients unable to give their free consent (incarcerated, legal protection measures)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHu grenoble alpes

Grenoble, France

Location

Related Publications (5)

  • 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: 11986017BACKGROUND

  • 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: 20347836BACKGROUND

  • 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: 26256133BACKGROUND

  • 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: 23294688BACKGROUND

  • 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: 30390183BACKGROUND

Study Officials

  • Bertrand TRILLING, MD, PhD

    BTrilling@chu-grenoble.fr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

July 8, 2020

Study Start

August 18, 2020

Primary Completion

July 9, 2021

Study Completion

September 9, 2021

Last Updated

September 21, 2022

Record last verified: 2022-09

Locations

FR(1)