Study hypothesis: Targinact is effective as oral analgesia after major colorectal surgery and
is associated with less gut dysfunction than Oxycodone.
Up to 40% of patients suffer delayed return of gut function after elective colorectal
surgery, leading to prolonged hospital stay and higher inpatient costs. For the patient, this
is characterised by a variety of symptoms including nausea and vomiting, delayed ability to
regain normal oral intake, abdominal discomfort/distension and constipation. Although
post-operative gut dysfunction tends to resolve spontaneously in 3-7 days, both symptoms and
supportive treatment (nasogastric tube insertion, repeated venous cannulation for intravenous
fluid administration etc) are unpleasant.
Elective colorectal surgery is a common hospital intervention hence a reduction in the
prevalence of post-operative gut dysfunction would be expected to benefit a large number of
patients with attendant reduction in health service costs. The objective aligns well with the
current national dissemination of Enhanced Recovery after Surgery programmes by the UK
Department of Health and Scottish Government.
Post-operative gut dysfunction is multifactorial. Opioid analgesics are contributory and all
Enhanced Recovery after Surgery (ERAS) programmes emphasise strategies to minimise systemic
opioid use (eg using regional or local anaesthetic techniques).
Targinact has not been evaluated in the setting of short-term post operative analgesia in
colorectal surgery but offers the potential to achieve effective analgesia with a lower
incidence of gut dysfunction and therefore an important role within the ERAS program after
colorectal surgery. Oxycodone is currently the oral opioid analgesic of choice in our unit
and most patients are prescribed a combination of oxycodone and oxynorm as step-down
analgesia following cessation of systemic or epidural analgesia, often in combination with
fentanyl patches.
Data will be collected from patient hospital records and questionnaires administered by the
principal investigator and research study nurse.
Multiple measures will be employed to record both presence of good function and absence of
dysfunction.
Time to first flatus
Time to first bowel movement
Time from surgery to cessation of iv fluids
Total dose of rescue antiemetic (protocol ondansetron not included)
Reinstitution of iv fluids (Y/N) Quantity of laxative used
Measurement of oral nutritional intake:
Preoperative intake will be recorded by means of a recall diary. Postoperative oral intake
will be recorded by the participant using a food diary for 7 days from the date of surgery.
Energy intake will then be estimated using CompEat Pro® forWindows® (Nutrition Systems,
Banbury, UK). Time to attain and maintain 80% of normal solid food intake and the percentage
Recommended Nutritional Intake (RNI) achieved on days 1-3 and days 5-7 after surgery will be
used in comparisons between study groups.
Validated nausea and vomiting score (Miles and Wengritzky)
Presence of abdominal distension (Y/N)
13C Stable Isotope Gastric Empyting Breath Test to measure gastric motility on the
second postoperative morning. The technique has been previously used in the Edinburgh
Department of Surgery and validated to be a reproducible and accurate measurement of
upper GI motility.
Additional data to be recorded:
Patient demographics, co morbidity, regular medications
Pre op bowel function questionnaire
Postoperative nausea and vomiting prediction data (Apfel score)
Day 3 achievement of discharge criteria (pain controlled by oral analgesia, tolerating
adequate oral diet and fluids, independently mobile and willing to go home) Y/N
30-day/Inpatient mortality
Duration of hospital admission
Complications (recorded by organ system and severity as assessed by Clavien/Dindo scale)
Unscheduled readmissions to hospital within 30 days of discharge
Patient-reported outcome questionnaire