Abdominal Massage After Colon Surgery for Cancer | NCT07713472

NCT07713472

Overview

NCT ID: NCT07713472
Lead Sponsor: University Hospital, GrenobleOTHER
Official Title: Benefits of Abdominal Massage After Colon Surgery for Cancer Following an ERAS Protocol (MATRAC_Ter): a Multicenter, Prospective, Randomized Clinical Trial
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 20, 2026Actual
Start Date: Jul 2026Estimated
Primary Completion Date: Dec 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

All included patients are required to have signed a study specific written informed consent form prior to inclusion in the trial.

Exclusion Criteria:

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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 225Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Mihaela Barbut, MScContact
mbarbut@chu-grenoble.fr00 334 76 76 48 02

Similar Studies

Participant Group/Arms

abdominal massage and usual physiotherapeutic interventionExperimental

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 MASSAGE

Other: Usual physiotherapeutic intervention

Usual physiotherapeutic interventionActive 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