Postoperative PainPhase 3TACSNCT02109640
A Comparison of Targinact vs. Oxycodone on Gut Function After Colorectal Surgery
A Phase 3 study testing Targinact, Oxycodone and Laparoscopic segmental colectomy in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Two key requirements for discharge from hospital after major abdominal surgery are adequate oral analgesia and resumption of oral nutrition. Up to 40% of patients suffer delayed discharge after abdominal surgery due to delayed return of gut function, manifesting as nausea, vomiting, constipation and abdominal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea and Vomiting
- What is being tested?
- Targinact, Oxycodone and Laparoscopic segmental colectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Aug 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective laparoscopic segmental colectomy at the Colorectal Surgery Unit, Western General Hospital, Edinburgh.
Who cannot join
- Pregnancy Age <18 years Patients lacking capacity to give informed consent. Severe liver dysfunction (Child's A or greater) Patients participating in another therapeutic clinical trial Contraindication to oxycodone, naloxone or Targinact Pre-existing dependence on opioid analgesia (current medications will be checked prior to discussing consent) Pre-existing use of opioid analgesia for chronic pain (current medications will be checked prior to discussing consent) Patients with rectal cancer Plan to form any stoma during procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Blinded Pilot Study to Compare Targinact vs. Oxycodone in Early Return of Gastrointestinal Function After Colorectal Surgery
Two key requirements for discharge from hospital after major abdominal surgery are adequate oral analgesia and resumption of oral nutrition. Up to 40% of patients suffer delayed discharge after abdominal surgery due to delayed return of gut function, manifesting as nausea, vomiting, constipation and abdominal distension. Opiates and their derivatives are the mainstay of postoperative analgesic regimens after abdominal surgery and are highly effective in achieving adequate pain control. However, opioids cause impaired gut function by reducing normal forward propulsion and increasing gut spasm. Opioid receptor blockers such as Alvimopan counteract these effects and can accelerate postoperative gut recovery but are expensive and cause cardiac complications; alternative painkillers such as non-steroidal anti-inflammatories are less effective than opioids and have been linked with increased risk of anastomotic leaks.
Targinact is a combination of prolonged release opioid analgesic (oxycodone hydrochloride) and naloxone hydrochloride (an opioid receptor blocker). The formulation of the product confines the naloxone action to the gut to reduce the unwanted side-effects on gut function. Targinact has been shown in patients with chronic severe pain to provide comparable analgesia to other opioid analgesics whilst reducing the unwanted side-effect of constipation.
The Investigators wish to test the hypothesis that Targinact will provide adequate analgesia after colonic resection with reduced postoperative gastrointestinal dysfunction. The surgical procedure chosen to test this hypothesis is laparoscopic segmental colectomy, a consistently reproducible intervention with a postoperative gut dysfunction rate of up to 40% (prospective data from the Edinburgh Colorectal Unit). The main outcome of the study will be return of normal gut function at the time of planned discharge (Day 3).
Read the detailed description
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
- Being tested
- Targinact, Oxycodone, Laparoscopic segmental colectomy
- Keywords
- Colorectal, Surgery, Laparoscopic, Analgesia, Enhanced Recovery, Targinact
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarginactDrug
Also called Oxycodone-Naloxone
Post-operative analgesia
OxycodoneDrug
Postoperative analgesia
Laparoscopic segmental colectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Targinact | Experimental | Oral Targinact 10-20mg bd following laparoscopic segmental colectomy Receives: Drug: Targinact; Procedure: Laparoscopic segmental colectomy |
| Oxycodone | Active comparator | Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy Receives: Drug: Oxycodone; Procedure: Laparoscopic segmental colectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Postoperative Gut Dysfunction
The proportion of participants with gut dysfunction, defined as the presence of any of the following sufficient to delay discharge on the 3rd postoperative day: nausea, vomiting, intolerance of oral intake or constipation.
Measured: Day 3 post-op
Secondary outcomes (2)
Total Opioid Analgesia Consumption
Total dose of systemic and oral Oxycodone or Targinact taken in hospital or at home until discontinued by the participant
Measured: Total postoperative period of analgesic consumption, an average of 1 week
Pain Scores
Overall Benefit of Analgesia Score (OBAS): Score range 0-28 with low score=high benefit. Summed from subscales of 0-4 for the following questions:
- Please rate your current pain at rest on a scale between 0⁄4 minimal pain and 4⁄4 maximum imaginable pain
- Please grade any distress and bother from vomiting in the past 24 h (0⁄4 not at all to 4⁄4 very much)
- Please grade any distress and bother from itching in the past 24 h (0⁄4 not at all to 4⁄4 very much)
- Please grade any distress and bother from sweating in the past 24 h (0⁄4 not at all to 4⁄4 very much)
- Please grade any distress and bother from freezing in the past 24 h (0⁄4 not at all to 4⁄4 very much)
- Please grade any distress and bother from dizziness in the past 24 h (0⁄4 not at all to 4⁄4 very much)
- How satisfied are you with your pain treatment during the past 24 h (0⁄4 not at all to 4⁄4 very much) Lehmann N. British Journal of Anaesthesia 105 (4): 511-18 (2010)
Measured: Postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugh M Paterson, MD FRCS, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109640
- Sponsor's protocol ID
- 2013-005327-16
- Acronym
- TACS
- Status last verified
- Feb 2017
- First submitted
- 3 Apr 2014
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170.
PubMed 19841366Hendry PO, Hausel J, Nygren J, Lassen K, Dejong CH, Ljungqvist O, Fearon KC; Enhanced Recovery After Surgery Study Group. Determinants of outcome after colorectal resection within an enhanced recovery programme. Br J Surg. 2009 Feb;96(2):197-205. doi: 10.1002/bjs.6445.
PubMed 19160347Simpson K, Leyendecker P, Hopp M, Muller-Lissner S, Lowenstein O, De Andres J, Troy Ferrarons J, Bosse B, Krain B, Nichols T, Kremers W, Reimer K. Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain. Curr Med Res Opin. 2008 Dec;24(12):3503-12. doi: 10.1185/03007990802584454.
PubMed 19032132Creamer F, Balfour A, Nimmo S, Foo I, Norrie JD, Williams LJ, Fearon KC, Paterson HM. Randomized open-label phase II study comparing oxycodone-naloxone with oxycodone in early return of gastrointestinal function after laparoscopic colorectal surgery. Br J Surg. 2017 Jan;104(1):42-51. doi: 10.1002/bjs.10322. Epub 2016 Oct 20.
PubMed 27762434
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Blinded Pilot Study to Compare Targinact vs. Oxycodone in Early Return of Gastrointestinal Function After Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02109640
- Acronym / sponsor ID
- TACS / 2013-005327-16
- Keywords
- Colorectal, Surgery, Laparoscopic, Analgesia, Enhanced Recovery, Targinact
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Posted 29 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two key requirements for discharge from hospital after major abdominal surgery are adequate oral analgesia and resumption of oral nutrition. Up to 40% of patients suffer delayed discharge after abdominal surgery due to delayed return of gut function, manifesting as nausea, vomiting, constipation and abdominal distension. Opiates and their derivatives are the mainstay of postoperative analgesic regimens after abdominal surgery and are highly effective in achieving adequate pain control. However, opioids cause impaired gut function by reducing normal forward propulsion and increasing gut spasm. Opioid receptor blockers such as Alvimopan counteract these effects and can accelerate postoperative gut recovery but are expensive and cause cardiac complications; alternative painkillers such as non-steroidal anti-inflammatories are less effective than opioids and have been linked with increased risk of anastomotic leaks.
Targinact is a combination of prolonged release opioid analgesic (oxycodone hydrochloride) and naloxone hydrochloride (an opioid receptor blocker). The formulation of the product confines the naloxone action to the gut to reduce the unwanted side-effects on gut function. Targinact has been shown in patients with chronic severe pain to provide comparable analgesia to other opioid analgesics whilst reducing the unwanted side-effect of constipation.
The Investigators wish to test the hypothesis that Targinact will provide adequate analgesia after colonic resection with reduced postoperative gastrointestinal dysfunction. The surgical procedure chosen to test this hypothesis is laparoscopic segmental colectomy, a consistently reproducible intervention with a postoperative gut dysfunction rate of up to 40% (prospective data from the Edinburgh Colorectal Unit). The main outcome of the study will be return of normal gut function at the time of planned discharge (Day 3).
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targinact | Experimental | Drug: Targinact, Procedure: Laparoscopic segmental colectomyOral Targinact 10-20mg bd following laparoscopic segmental colectomy |
| Oxycodone | Active comparator | Drug: Oxycodone, Procedure: Laparoscopic segmental colectomyOral oxycodone 10-20mg bd following laparoscopic segmental colectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective laparoscopic segmental colectomy at the Colorectal Surgery Unit, Western General Hospital, Edinburgh.
Key exclusion criteria (1 listed)
- Pregnancy Age <18 years Patients lacking capacity to give informed consent. Severe liver dysfunction (Child's A or greater) Patients participating in another therapeutic clinical trial Contraindication to oxycodone, naloxone or Targinact Pre-existing dependence on opioid analgesia (current medications will be checked prior to discussing consent) Pre-existing use of opioid analgesia for chronic pain (current medications will be checked prior to discussing consent) Patients with rectal cancer Plan to form any stoma during procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TarginactAlso: Oxycodone-NaloxonePost-operative analgesia | Drug | Targinact |
| OxycodonePostoperative analgesia | Drug | Oxycodone |
| Laparoscopic segmental colectomy | Procedure or surgery | Oxycodone, Targinact |
Primary outcome
Prevalence of Postoperative Gut Dysfunction
Time frame: Day 3 post-op
The proportion of participants with gut dysfunction, defined as the presence of any of the following sufficient to delay discharge on the 3rd postoperative day: nausea, vomiting, intolerance of oral intake or constipation.
2 secondary outcomes
Total Opioid Analgesia Consumption
Time frame: Total postoperative period of analgesic consumption, an average of 1 week
Pain Scores
Time frame: Postoperative day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19841366Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170.
- Background: PubMed 19160347Hendry PO, Hausel J, Nygren J, Lassen K, Dejong CH, Ljungqvist O, Fearon KC; Enhanced Recovery After Surgery Study Group. Determinants of outcome after colorectal resection within an enhanced recovery programme. Br J Surg. 2009 Feb;96(2):197-205. doi: 10.1002/bjs.6445.
- Background: PubMed 19032132Simpson K, Leyendecker P, Hopp M, Muller-Lissner S, Lowenstein O, De Andres J, Troy Ferrarons J, Bosse B, Krain B, Nichols T, Kremers W, Reimer K. Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain. Curr Med Res Opin. 2008 Dec;24(12):3503-12. doi: 10.1185/03007990802584454.
- Derived from this study: PubMed 27762434Creamer F, Balfour A, Nimmo S, Foo I, Norrie JD, Williams LJ, Fearon KC, Paterson HM. Randomized open-label phase II study comparing oxycodone-naloxone with oxycodone in early return of gastrointestinal function after laparoscopic colorectal surgery. Br J Surg. 2017 Jan;104(1):42-51. doi: 10.1002/bjs.10322. Epub 2016 Oct 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugh M Paterson, MD FRCS principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Targinact, Oxycodone and Laparoscopic segmental colectomy in people with Postoperative Pain and Postoperative Nausea and Vomiting, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Postoperative Gut Dysfunction (time frame: Day 3 post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02109640, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.