Abdominal Massage After Colon Surgery for Cancer
ConditionColonic Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients required emergency surgery (obstruction or peritonitis),
A stoma for whatever reason,
Rectal cancer,
BMI > 40,
Trial design
Design model
Parallel
Treatments tested in this trial
ABDOMINAL MASSAGE
Other interventionAbdominal 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 intervention
Other interventionthe 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.
Treatment groups
225 Participants
are divided into 2 treatment groupsGroup A: abdominal massage and usual physiotherapeutic interventionExperimental treatment 2 interventions
Group B: Usual physiotherapeutic interventionActive comparator 1 intervention
Trial outcomes
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.
Time frame
Through study completion, 30 daysSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: