Colorectal SurgeryMATRACNCT04462705
Abdominal Massage to Prevent Postoperative Ileus After Colorectal Surgery
A study testing Usual physiotherapeutic intervention and Abdominal Massage in people with Colorectal Surgery, run by University Hospital, Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Usual physiotherapeutic intervention and Abdominal Massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 18 Aug 2020to 9 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Mental disorders
- Cutaneous infection on the abdomen
- Pregrancy and breast feeding
- Patients unable to give their free consent (incarcerated, legal protection measures)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Abdominal Massage to Prevent Postoperative Ileus as Part of an Enhanced Recovery Program After Colorectal Surgery
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.
Read more
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.
- Conditions
- Colorectal Surgery
- Being tested
- Usual physiotherapeutic intervention and Abdominal Massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual physiotherapeutic intervention and Abdominal MassageProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Usual physiotherapeutic intervention and Abdominal Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of abdominal massage on time to normal bowel function after colorectal surgery
Time to normal bowel function
Measured: through study completion, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start18 Aug 2020
- Primary completion9 Jul 2021
- Study completion9 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand TRILLING, MD, PhD, Principal investigator, BTrilling@chu-grenoble.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462705
- Sponsor's protocol ID
- 38RC20.021
- Acronym
- MATRAC
- Status last verified
- Sep 2022
- First submitted
- 20 Feb 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 11986017Bauer 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.
PubMed 20347836Dreyer 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.
PubMed 26256133Chapelle 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.
PubMed 23294688Navalgund 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.
PubMed 30390183
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Massage to Prevent Postoperative Ileus as Part of an Enhanced Recovery Program After Colorectal Surgery
- ClinicalTrials.gov ID
- NCT04462705
- Acronym / sponsor ID
- MATRAC / 38RC20.021
- Conditions
- Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual physiotherapeutic intervention | Active comparator | Procedure: Usual physiotherapeutic intervention and Abdominal Massagethe 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 |
| abdominal massage and usual physiotherapeutic intervention | Experimental | Procedure: Usual physiotherapeutic intervention and Abdominal Massagethe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Mental disorders
- Cutaneous infection on the abdomen
- Pregrancy and breast feeding
- Patients unable to give their free consent (incarcerated, legal protection measures)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual physiotherapeutic intervention and Abdominal MassageAbdominal 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. | Procedure or surgery | Usual physiotherapeutic intervention, abdominal massage and usual physiotherapeutic intervention |
Primary outcome
Evaluate the effect of abdominal massage on time to normal bowel function after colorectal surgery
Time frame: through study completion, 30 days
Time to normal bowel function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Background: PubMed 11986017Le 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.
- Background: PubMed 20347836Bauer 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.
- Background: PubMed 26256133Dreyer 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.
- Background: PubMed 23294688Chapelle 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.
- Background: PubMed 30390183Navalgund 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand TRILLING, MD, PhD principal investigator
BTrilling@chu-grenoble.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual physiotherapeutic intervention and Abdominal Massage in people with Colorectal Surgery, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of abdominal massage on time to normal bowel function after colorectal surgery (time frame: through study completion, 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04462705, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.