Low Anterior Resection Syndrome
Conditions
Interventions
Trade Name: Glycerol "OBA"
Pharmaceutical Form: Suppository
INN or Proposed INN: Glycerol
Other descriptive name: GLYCEROL
Concentration
Sponsors
Department of Surgery, Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients electively treated for rectal cancer with a low anterior resection. 2. Unsuccessful PCT after at least 4 weeks of treatment for LARS (LARS score >29 at evaluation). 3. At least 3 months after surgery (including reversal of a temporary loop-ileostomy). 4. Age > 18 years 5. Ability to understand written and spoken language actual for the including site (due to questionnaire validity). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 57 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 57
Exclusion criteria
Exclusion criteria: 1. Former use of TAI 2. Anastomotic stenosis 3. History of anastomotic leakage 4. Current metastatic disease or local recurrence 5. Ongoing oncological treatment 6. Postoperative radiotherapy for rectal cancer 7. Previous or current cancer in the pelvic organs 8. Underlying diarrhoeal disease 9. Inflammatory bowel disease 10. Symptom 1 in MYMOP cannot be classified as a LARS symptom 11. Dementia 12. Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant neurologic disease assessed to be a contributory cause to LARS symptoms. 13. Inability of patient to use TAI 14. Inability and unwillingness to give informed consent 15. Pregnancy or intention to become pregnant during the trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TAI is used as a second-line treatment following unsuccessful personalised conservative treatment (PCT) of LARS. However, it is unknown if scheduled, initiated defecation with the aid of a glycerol suppository will have the same clinical effect as TAI. Thus, the aim of this study is to compare the effect of TAI with a glycerol suppository in patients suffering from major LARS. ;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint will be the improvement of the main symptom using the Measure My Medical Outcome Profile (MYMOP) score comparing the TAI group to the glycerol suppository group.; Timepoint(s) of evaluation of this end point: Baseline, 4 weeks, 8 weeks and at closeout in week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Assessment of bowel function with the LARS Score and the Memorial Sloan-Kettering Cancer Centre (MSKCC) Bowel Function Instrument (BFI). 2. Assessment of the faecal incontinence status with The St. Mark's Incontinence Score. 3. Assessment of QOL and bowel function-related QOL with the EORTC QLQ-C30 and EORTC QLQ-CR29. 4. Assessment of urinary function with The International Consultation on Incontinence Questionnaire Male/Female Lower Urinary Tract Symptoms (ICIQ-M/F-LUTS). 5. Assessment of sexual function with The Rectal Cancer Female Sexuality Score and The International Index of Erectile Function. 6. Real-time registration of bowel function with the Journl smartphone-based application. Main events recorded will be: Bowel movements, incontinence episodes (total, passive, and urge), urge episodes, urge time, incomplete emptying, soiling, daily gas incontinence, daily impact on QOL and social activities. 7. LARS international consensus items 8. Health economics 9. EQ5D-5L ; Timepoint(s) of evaluation of this end point: Baseline and closeout at week 12. Secondary endpoints 1-3 additionally in week 4 and week 8. | — |
Countries
Denmark
Contacts
Public ContactDepartment of Surgery, Aarhus Unive
Aarhus University Hospital
Outcome results
None listed