TES RCT Fleet Enema vs Oral Mechanical Bowel Prep
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNova Scotia Health Authority
About this trial
There is no consensus about the best bowel preparation prior to transanal endoscopic surgery TES). Cleanliness and visibility in the rectosigmoid and rectum are of utmost importance, possibly even more so than during colonoscopy, to facilitate safe, precise and efficient resection of the rectal lesion and potentially adequate closure of the defect. Both Fleet enemas and oral mechanical bowel preparation are considered standard of care in preparation for TES. This single center two arm single blinded randomized controlled trial will compare the effectiveness of Fleet enemas in comparison to Pico Salax oral mechanical bowel preparation in cleansing the rectum as measured by a modified version of the Ottawa Bowel Prep Scale.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
undergoing transanal endoscopic surgery at the QEII Health Sciences Center in Halifax by one of the colorectal trained surgeons
Disqualifiers
chronic constipation not well controlled with diet or stool softening agents
previous pelvic radiation
inflammatory bowel disease
repeat transanal surgery for the same lesion
Trial design
Design model
Parallel
Treatments tested in this trial
Fleet Enema
Drugstandard pre-op application, see arm description
Pico-Salax
Drugstandard pre-op application, see arm description
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Fleet EnemaActive comparator 1 intervention
Group B: Pico SalaxActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quality of bowel preparation
Measurement of the quality of cleanse of the rectum, expressed as a score on a modified version of the Ottawa Bowel Prep Scale (OBPS). The OBPS will be used to assess the one segment of the bowel visualized during TES surgery (rectosigmoid) using the segmental scale 0-4, where 0 is the best score and 4 is inadequate.
Time frame
A one-time intra-operative assessment for each patientSecondary outcomes
1
Validation of the modified version of the Ottawa Bowel Prep Scale
validation of the modified version of the OBPS as it applies to the use of Fleet enema and Pico Salax oral bowel prep in the rectosigmoid segment specifically for use in preparation for TES
Time frame
A one-time intra-operative assessment for each patient by a second blinded surgeon2
Time spent cleaning operating field
A measure of the time spent cleansing the operating field by the surgeon as per review of recording of the surgery
Time frame
A one-time intra-operative assessment for each patient3
Ability to close the surgical defect
An assessment as to whether the surgical wound in the rectum was left open or sutured closed
Time frame
A one-time intra-operative assessment for each patient4
Patient tolerability of preparation
An assessment of the patients tolerability of the prep, symptoms associated with the prep, whether they were able to complete the prep, satisfaction and willingness to take the same prep in the future, performed using a questionnaire. In the questionnaire, the severity of the symptoms associated with the prep can be selected from mild, moderate, severe, and intolerable.
Time frame
A one-time pre-op assessment for each patient the morning of surgerySponsors and contacts
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Source ClinicalTrials.gov