Trial Outcomes & Findings for A Comparison of Targinact vs. Oxycodone on Gut Function After Colorectal Surgery (NCT NCT02109640)

Last Updated: 2017-03-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

50 participants

Primary outcome timeframe

Day 3 post-op

Results posted on

2017-03-29

Participant Flow

62 patients consented to study participation but 12 were not assigned to the study. This was because consent was obtained a few weeks before the date of surgery and in that interval 12 patients became ineligible (change of planned operation, presentation as emergency, development of ineligibility criteria, withdrawn from anaesthetic protocol).

Participant milestones

Participant milestones
Measure	Targinact Oral Targinact 10-20mg bd following laparoscopic segmental colectomy Targinact: Post-operative analgesia Laparoscopic segmental colectomy	Oxycodone Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy Oxycodone: Postoperative analgesia Laparoscopic segmental colectomy
Overall Study STARTED	27	23
Overall Study COMPLETED	27	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Targinact vs. Oxycodone on Gut Function After Colorectal Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Targinact n=27 Participants Oral Targinact 10-20mg bd following laparoscopic segmental colectomy Targinact: Post-operative analgesia Laparoscopic segmental colectomy	Oxycodone n=23 Participants Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy Oxycodone: Postoperative analgesia Laparoscopic segmental colectomy	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 3 post-op

Outcome measures

Outcome measures
Measure	Targinact n=27 Participants Oral Targinact 10-20mg bd following laparoscopic segmental colectomy Targinact: Post-operative analgesia Laparoscopic segmental colectomy	Oxycodone n=23 Participants Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy Oxycodone: Postoperative analgesia Laparoscopic segmental colectomy
Prevalence of Postoperative Gut Dysfunction	13 Participants	15 Participants

SECONDARY outcome

Timeframe: Total postoperative period of analgesic consumption, an average of 1 week

Total dose of systemic and oral Oxycodone or Targinact taken in hospital or at home until discontinued by the participant

Outcome measures

Outcome measures
Measure	Targinact n=27 Participants Oral Targinact 10-20mg bd following laparoscopic segmental colectomy Targinact: Post-operative analgesia Laparoscopic segmental colectomy	Oxycodone n=23 Participants Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy Oxycodone: Postoperative analgesia Laparoscopic segmental colectomy
Total Opioid Analgesia Consumption	78 milligram morphine equivalents Standard Deviation 36	94 milligram morphine equivalents Standard Deviation 56

SECONDARY outcome

Timeframe: Postoperative day 3

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)

Outcome measures

Outcome measures
Measure	Targinact n=27 Participants Oral Targinact 10-20mg bd following laparoscopic segmental colectomy Targinact: Post-operative analgesia Laparoscopic segmental colectomy	Oxycodone n=23 Participants Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy Oxycodone: Postoperative analgesia Laparoscopic segmental colectomy
Pain Scores	2 units on a scale Interval 0.0 to 10.0	2 units on a scale Interval 0.0 to 11.0

Adverse Events

Targinact

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Oxycodone

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Targinact n=27 participants at risk Oral Targinact 10-20mg bd following laparoscopic segmental colectomy Targinact: Post-operative analgesia Laparoscopic segmental colectomy	Oxycodone n=23 participants at risk Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy Oxycodone: Postoperative analgesia Laparoscopic segmental colectomy
Gastrointestinal disorders Anastomotic leak	3.7% 1/27 • Number of events 1 • 30 days postoperative	0.00% 0/23 • 30 days postoperative
Gastrointestinal disorders Intraabdominal fluid collection	3.7% 1/27 • Number of events 1 • 30 days postoperative	0.00% 0/23 • 30 days postoperative

Other adverse events

Other adverse events
Measure	Targinact n=27 participants at risk Oral Targinact 10-20mg bd following laparoscopic segmental colectomy Targinact: Post-operative analgesia Laparoscopic segmental colectomy	Oxycodone n=23 participants at risk Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy Oxycodone: Postoperative analgesia Laparoscopic segmental colectomy
Cardiac disorders Hypotension	40.7% 11/27 • Number of events 11 • 30 days postoperative	47.8% 11/23 • Number of events 11 • 30 days postoperative
Renal and urinary disorders Acute urinary retention	14.8% 4/27 • Number of events 4 • 30 days postoperative	4.3% 1/23 • Number of events 1 • 30 days postoperative
Respiratory, thoracic and mediastinal disorders Hypoxaemia postop	11.1% 3/27 • Number of events 3 • 30 days postoperative	13.0% 3/23 • Number of events 3 • 30 days postoperative
General disorders Wound healing	14.8% 4/27 • Number of events 4 • 30 days postoperative	13.0% 3/23 • Number of events 3 • 30 days postoperative

Additional Information

Hugh M Paterson

University of Edinburgh

Phone: 44 131 537 1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place