Phase
Condition
Rectal Cancer
Digestive System Neoplasms
Colon Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult aged from 18 years
Patients electively treated for rectal cancer with a low anterior resection
Between 3 and 18 months after the conservative colorectal surgery or 3 and 18 monthsafter the stoma reversal if applicable
LARS score >= 25 (minor or major LARS) (Emmertsen and Laurberg 2012) AND LARSdefinition as consensus with at least one symptom that results in at least oneconsequence (Keane et al. 2020)
Adult for whom previous conservative treatments were started for at least a month
Mental and physical capability of the patient to handle the MiniGo by himself.
Check of the anastomosis (no signs of leakage or clinical relevant stenosis) andabsence of local recurrence by Rectal digital examination of the anastomosis, anyother exam used in the current practice
Patient affiliated to the health social security system
Exclusion
Exclusion Criteria:
Contra-indication to use TAI
Former use of TAI (post colo-rectal surgery)
Clinically relevant stenosis
Current metastatic disease or local recurrence
Ongoing chemotherapy
Postoperative radiotherapy for rectal cancer
History of diarrhoeal disease
Inflammatory bowel disease
Dementia
Spinal cord injury, multiple sclerosis, Parkinson's disease or other significantdisease assessed to be a contributory cause to LARS symptoms.
Patient with cancer recurrence
Patient with a life expectancy < 1 year
Participating to another clinical trial for the treatment of LARS symptom
Ongoing pelvic floor rehabilitation/biofeedback
Pregnancy or intention to become pregnant during the trial period
Inability and unwillingness to give informed consent
Study Design
Connect with a study center
CHU Amiens-Picardie
Amiens, 80054
FranceActive - Recruiting
CHU Besançon
Besançon, 25030
FranceActive - Recruiting
Clinique Tivoli-Ducos
Bordeaux, 33000
FranceActive - Recruiting
CHU Grenoble
La Tronche, 38700
FranceActive - Recruiting
CHU Timone
Marseille, 13005
FranceSite Not Available
CHU de NANTES, Hôtel Dieu
Nantes, 44093
FranceActive - Recruiting
CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE
Pessac, 33604
FranceSite Not Available
CH Lyon Sud
Pierre-benite, 69495
FranceSite Not Available
CHU Charles Nicolle - Rouen
Rouen, 76 031
FranceActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.