NCT07713472

Brief Summary

Postoperative ileus is a transient gastrointestinal dysmotility following abdominal surgery that leads to bloating, abdominal distention, visceral pain, nausea, vomiting, and delayed passage of flatus and stool. This paralytic state lasts longer when surgery involves the distal rather than the proximal digestive tract. Its incidence following colorectal surgery is between 10% and 30%. The main factors of postoperative ileus include age, predisposed constipation, method of anesthesia, type of surgical approach, perioperative analgesia, inflammatory reactions, and the psychopathology of the patient. Enhanced recovery after surgery (ERAS) provides patients with optimal means to counteract or minimize the deleterious effects of surgery, in particular toward minimizing postoperative ileus. Expert consensus among surgeons, anesthesiologists, physiotherapists, dieticians, and other team members has been reached that stated 24 clinical statements concerning preoperative, peroperative and postoperative periods that should be included in current rehabilitation programs in colorectal surgery. In China, massage, a 3000-year-old therapy guided by the theory of Yin and Yang, is widely used to treat various diseases. Chapelle and Bowe showed that abdominal massage reduced experimental postoperative ileus in a rat model and suggested that the effect was due to the attenuation of inflammation. Abdominal massage has not widely been applied after colorectal surgery. Due to the scarcity of literature on abdominal massage, it has never been considered to be part of ERAS recommendations in colorectal surgery. Nevertheless, massage involving profound maneuvering of the viscera through abdominal palpation and breathing has been used as part of the local postoperative protocol in our department for many years with interesting results, and no complication has been reported. To our knowledge, only one study has explored the effect of mechanical abdominal massage on the duration of ileus after colectomy. The aim of this prospective, multicenter randomized controlled trial (RCT) is to compare return of intestinal transit using the GI-2 criteria as defined by the time to first defecation and time to tolerance of solid food following the operation in two groups of patients following an ERAS protocol for colonic cancer surgery, one with and the other without early postoperative abdominal massage.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress4%
Jul 2026Aug 2028

First Submitted

Initial submission to the registry

June 26, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

June 26, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

Postoperative ileusSurgeryColonic cancerAbdominal massagePhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effectiveness of abdominal massage on the resumption of digestive transit after colonic resection surgery for cancer as part of ERAS protocol.

    The primary outcomes is the return of intestinal transit, as defined by the time to first defaecation and time to tolerance of solid food following the operation, calculated in hours from skin closure.

    Through study completion, 30 days

Study Arms (2)

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.

Other: ABDOMINAL MASSAGEOther: Usual physiotherapeutic intervention

Usual physiotherapeutic intervention

ACTIVE COMPARATOR

the usual physiotherapeutic intervention (respiratory and walking exercises). Each patient 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.

Other: Usual physiotherapeutic intervention

Interventions

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.

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: 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.

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:

  • Adults programmed to undergo surgery involving right, transverse or left colectomy due to cancer with anastomosis, regardless the approach (laparoscopy.
  • Laparotomy and Robot-assisted). Patients must be able to follow the colorectal surgery unit's ERAS protocol.

You may not qualify if:

  • Patients required emergency surgery (obstruction or peritonitis),
  • A stoma for whatever reason,
  • Rectal cancer,
  • BMI \> 40,
  • Psychiatric disorders,
  • An associated procedure, extensive resection,
  • Pregnancy, deprivation of liberty by judicial or administrative decision, or being under legal protection and patients with a hierarchical link to the principal investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble Alpes

Grenoble, 38043, France

Location

Related Publications (15)

  • van Bree SH, Vlug MS, Bemelman WA, Hollmann MW, Ubbink DT, Zwinderman AH, de Jonge WJ, Snoek SA, Bolhuis K, van der Zanden E, The FO, Bennink RJ, Boeckxstaens GE. Faster recovery of gastrointestinal transit after laparoscopy and fast-track care in patients undergoing colonic surgery. Gastroenterology. 2011 Sep;141(3):872-880.e1-4. doi: 10.1053/j.gastro.2011.05.034. Epub 2011 May 26.

    PMID: 21699777BACKGROUND
  • 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
  • Vincent D, Barbut M, Fisher J, et al. Is there any benefit to immediate postoperative abdominal massage in colorectal surgery? La revue de kinésithérapie 2026; in press

    BACKGROUND
  • Faucheron JL, Vincent D, Barbut M, Jacquet-Perrin I, Sage PY, Foote A, Quesada JL, Trilling B, Tidadini F. How long for gastrointestinal recovery following small bowel, right, or left colonic resection with anastomosis in a full fast-track recovery protocol? Int J Colorectal Dis. 2025 Apr 14;40(1):93. doi: 10.1007/s00384-025-04855-4.

    PMID: 40229620BACKGROUND
  • Faucheron JL, Vincent D, Barbut M, Jacquet-Perrin I, Sage PY, Foote A, Bellier A, Quesada JL, Tidadini F, Trilling B. Abdominal massage to prevent ileus after colorectal surgery. A single-center, prospective, randomized clinical trial: the MATRAC Trial. Tech Coloproctol. 2024 Mar 22;28(1):42. doi: 10.1007/s10151-024-02914-6.

    PMID: 38517591BACKGROUND
  • Wang Y, Xu J, Bao R, Li Z. Massage for gastrointestinal function among participants after abdominal surgery. A protocol for systematic review and meta-analysis. Medicine 21201.100(49):e28087 12. Chapelle SL, Bove GM. Visceral massage reduces postoperative ileus in a rat model. J Bodyw Mov Ther 2013;17:83-88

    BACKGROUND
  • Trilling B, Sage PY, Faucheron JL. What is fast track multimodal management of colorectal cancer surgery in real life? Tech Coloproctol. 2018 May;22(5):401-402. doi: 10.1007/s10151-018-1799-9. Epub 2018 Jun 1. No abstract available.

    PMID: 29855815BACKGROUND
  • Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.

    PMID: 30426190BACKGROUND
  • Alfonsi P, Slim K, Chauvin M, Mariani P, Faucheron JL, Fletcher D; Working Group of Societe francaise d'anesthesie et reanimation (SFAR); Societe francaise de chirurgie digestive (SFCD). French guidelines for enhanced recovery after elective colorectal surgery. J Visc Surg. 2014 Feb;151(1):65-79. doi: 10.1016/j.jviscsurg.2013.10.006. Epub 2013 Dec 27.

    PMID: 24378143BACKGROUND
  • Mazzotta E, Villalobos-Hernandez EC, Fiorda-Diaz J, Harzman A, Christofi FL. Postoperative Ileus and Postoperative Gastrointestinal Tract Dysfunction: Pathogenic Mechanisms and Novel Treatment Strategies Beyond Colorectal Enhanced Recovery After Surgery Protocols. Front Pharmacol. 2020 Nov 24;11:583422. doi: 10.3389/fphar.2020.583422. eCollection 2020.

    PMID: 33390950BACKGROUND
  • Bragg D, El-Sharkawy AM, Psaltis E, Maxwell-Armstrong CA, Lobo DN. Postoperative ileus: Recent developments in pathophysiology and management. Clin Nutr. 2015 Jun;34(3):367-76. doi: 10.1016/j.clnu.2015.01.016. Epub 2015 Jan 31.

    PMID: 25819420BACKGROUND
  • Sugawara K, Kawaguchi Y, Nomura Y, Suka Y, Kawasaki K, Uemura Y, Koike D, Nagai M, Furuya T, Tanaka N. Perioperative Factors Predicting Prolonged Postoperative Ileus After Major Abdominal Surgery. J Gastrointest Surg. 2018 Mar;22(3):508-515. doi: 10.1007/s11605-017-3622-8. Epub 2017 Nov 8.

    PMID: 29119528BACKGROUND
  • Venara A, Neunlist M, Slim K, Barbieux J, Colas PA, Hamy A, Meurette G. Postoperative ileus: Pathophysiology, incidence, and prevention. J Visc Surg. 2016 Dec;153(6):439-446. doi: 10.1016/j.jviscsurg.2016.08.010. Epub 2016 Sep 23.

    PMID: 27666979BACKGROUND
  • Kronberg U, Kiran RP, Soliman MS, Hammel JP, Galway U, Coffey JC, Fazio VW. A characterization of factors determining postoperative ileus after laparoscopic colectomy enables the generation of a novel predictive score. Ann Surg. 2011 Jan;253(1):78-81. doi: 10.1097/SLA.0b013e3181fcb83e.

    PMID: 21233608BACKGROUND
  • Vather R, Trivedi S, Bissett I. Defining postoperative ileus: results of a systematic review and global survey. J Gastrointest Surg. 2013 May;17(5):962-72. doi: 10.1007/s11605-013-2148-y. Epub 2013 Feb 2.

    PMID: 23377782BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

June 26, 2026

First Posted

July 20, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

August 31, 2028

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations