E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing emergency laparotomy due to either Intestinal obstruction or perforated abdominal viscus. |
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E.1.1.1 | Medical condition in easily understood language |
Patients who are being operated on for an acute abdominal condition, more precisely bowel obstruction or perforated stomach or intestine |
Patienter som bliver opereret for akut tilstand i maven, mere præcist tarmslyng eller hul på mavesækken eller tarmen |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10053361 |
E.1.2 | Term | Explorative laparotomy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051379 |
E.1.2 | Term | Systemic inflammatory response syndrome |
E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 22.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10021328 |
E.1.2 | Term | Ileus |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034406 |
E.1.2 | Term | Perforation bowel |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034430 |
E.1.2 | Term | Perforation stomach |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate changes in plasma C-reactive protein, assessed 6 hours after surgery and T24*, T72* and T120* (*+/- 6 hours) after surgery. |
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E.2.2 | Secondary objectives of the trial |
Postoperative inflammatory responses
Fluid distribution, both intravascular and extravascular during the early postoperative period
Pulmonary function by Peak Expiratory Flow measurements during the early postoperative period
Postoperative need for antiemetic and analgesic beyond standard course during the early perioperative period
Fatigue + mobilization, assessed by the physical therapists daily via Cumulated ambulation score
Postoperative delirium via Confusion Assessment method
Postoperative resting pain measured according to Numeric Rating Scale (NRS)
30-day postoperative mortality
30-day postoperative complications
Length of ICU
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Adults (18 years or over) undergoing emergency laparotomy (laparotomy or laparoscopy) for following abdominal pathology: a. Primary perforated viscus (perforated ulcer, small intestine or colon) b. Primary intestinal obstruction ( small intestine or colon) 2. Provided verbal and written informed consent 3. Must speak and understand the Danish language
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E.4 | Principal exclusion criteria |
1. Appendectomies, cholecystectomies, negative diagnostic laparoscopies/laparotomies, herniotomies without bowel resections, sub-acute internal hernias after gastric bypass surgery, sub-acute surgery for inflammatory bowel diseases. 2. Emergency re-operations after elective surgery owing to paralytic/obstructive ileus, perforated viscus, anastomotic leakage 3. Reoperation owing to fascial separation with no other abdominal pathology identified and sub-acute colorectal cancer-surgery will be excluded from the cohort. Sub-acute surgery is defined as surgery planned within 48 hours. 4. Intestinal Ischemia 5. intraabdominal bleeding 6. Traumas, gynecological, urogenital and other vascular pathology, pregnant participants. 7. Dementia and/or cognitive dysfunction (diagnosed). 8. Participants not oriented in time, place and person 9. Insuline treatment for diabetes mellitus type I and II 10. Current treatment with systemic glucocorticoids or immune suppressive treatment ( apart from inhalation steroids) 11. Allergies to trial medicine
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in plasma C-reactive protein, assessed 6 hours after surgery and T24*, T72* and T120* (*+/- 6 hours) after surgery. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
preoperatively, 6 hours after surgery and T24*, T72* and T120* (*+/- 6 hours) after surgery. |
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E.5.2 | Secondary end point(s) |
Postoperative inflammatory responses (IL-6, TNT)
Change in plasma Syndecain-1, plasma soluble thrombomodulin (sTM)(CD141), plasma sE-Selectin (CD62E) and vascular endothelial growth factor (VEGF),
qSOFA score, assessed once preoperatively and 4 times daily during the first 5 postoperative days
Fluid distribution, both intravascular (via stroke volume(SV) guided resuscitation) and extravascular (full body water via bioelectrical impedance vector analysis)
Pulmonary function during the perioperative period by Peak Expiratory Flow measurements
Postoperative need for antiemetic and analgesic beyond standard course
Fatigue + mobilization, assessed by the physical therapists daily
Postoperative delirium via Confusion Assessment method
Postoperative resting pain measured according to Numeric Rating Scale (NRS)
30-day postoperative mortality
30-day postoperative complications
Length of ICU
|
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
preoperatively, 6 hours after surgery and T24*, T72* and T120* (*+/- 6 hours) after surgery. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial is defined as the completion of data collection described in the protocol, for an individual participant that entails a 30-day period from day of inclusion. |
Afslutningen af forsøget defineres som færdiggørelsen af dataindsamling beskrevet i protokollen for en individuel deltager, der indebærer en periode på 30 dage fra dagen for inklusionen. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |