Trial · NCT01424150
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disability-free Survival | 1 year postoperative | Disability-free survival up to 1 year: survival and freedom from disability. The latter is defined as a persistent (≥6 months) reduction in health status as measured by a 12-item version (12-60 points) of World Health Organisation Disability Assessment Schedule score (WHODAS) of 24 points, reflecting a disability level of at least 25% and being the threshold point between "disabled" and "not disabled" as per WHO guidelines. Disability will be assessed by the participant, but if unable then we will use the proxy's report. The date of onset of new disability will be recorded. Further details are provided in the Procedures Manual and the Statistical Analysis Plan. |
| Secondary | Death | 90 days, then up to 12 months after surgery | deceased within 12 months |
| Secondary | Composite Septic Outcome or Death | 30 days postoperative | composite of 1 or more of:sepsis, surgical site infection, anastomotic leak, death and pneumonia |
| Secondary | Sepsis | 30 days postoperative | using Centers for Disease Control and Prevention (CDC) with National Healthcare Safety Network (NHSN) criteria, two or more features of the systematic inflammatory response syndrome (SIRS) plus evidence of a source or site of infection (can be positive blood culture or purulence from any site) |
| Secondary | Surgical Site Infection | 30 days postoperative | using CDC criteria (http://www.cdc.gov/nhsn/PDFs/pscManual/9pscSSIcurrent.pdf): |
| Secondary | Pneumonia | 30 Days postoperative | The presence of new and/or progressive pulmonary infiltrates on chest radiograph plus two or more of the following: 1. Fever ≥ 38.5°C or postoperative hypothermia \<36°C 2. Leukocytosis ≥ 12,000 WBC/mm3 or leukopenia \< 4,000 WBC/mm3 3. Purulent sputum and/or 4. New onset or worsening cough or dyspnoea. |
| Secondary | Acute Kidney Injury | 30 days postoperative | according to The Kidney Disease: Improving Global Outcomes (KDIGO) group criteria, but not urine output - for Stage 2 or worse AKI defined as at least 2-fold increase in creatinine, or estimated GFR decrease \>50%.(73) We also plan to report renal replacement therapy up to 90 days after surgery. Because a restrictive IV fluid regimen may artificially elevate serum creatinine due to a smaller dilutional effect from less IV fluids, we therefore calculated adjusted creatinine by first estimating the volume of distribution for creatinine as equal to total body water (assumed to be 60% of body weight, expressed in mL). |
| Secondary | Pulmonary Oedema | 30 days postoperative | respiratory distress or impaired oxygenation AND radiological evidence of pulmonary oedema |
| Secondary | Total Duration of Time Spend in the ICU or HDU (in Days) | 30 day postoperative | including initial ICU admission and readmission times up to 30 days post operatively |
| Secondary | Hospital Stay | 30 days postoperative | from the start (date, time) of surgery until actual hospital discharge |
| Secondary | Quality of Recovery | days 3 | 15-item Quality of Recovery Score. The score is a patient reported outcome measure to score the individuals recovery following anaesthesia and surgery. Minimum value is 0 and maximum value is 150. The score of 150 is good. The higher the score the better |
| Secondary | Anastomotic Leak | 30 days postoperative | A defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- an extra luminal compartments. |
| Secondary | C-reactive Protein | Day 3 postoperative | plasma C-reactive protein (CRP, using site-specific assay) concentration on Day 3 |
| Secondary | mmol/L | 24 hours post surgery | peak serum lactate within 24 hours of surgery |
| Secondary | Total ICU Stay and Unplanned ICU Admission to ICU | 30 days postoperative | additive, including initial ICU admission and readmission times up to Day 30 |
| Other | Preplanned Substudies (for Mechanistic Understanding) | 5 years | We plan several substudies (to be funded from other sources), each of which will have a separate protocol and authorship plan (using an expanded list of contributors). Additional blood tests and other investigations will be done at selected hospitals according to local interest and expertise. 1. Cost-effectiveness, to include hospital stay and complications as we have done previously 2. Hyperchloraemic acidosis (to measure strong ion difference, Cl-, lactate, albumin …) 3. Pulmonary oedema and acute lung injury (to measure FiO2/PaO2 ratio, CT/CXR-confirmed atelectasis …) 4. Perioperative oliguria and acute kidney injury 5. Obesity and perioperative risk 6. BNP and risk prediction 7. Goal directed therapy - decision analysis 8. Perioperative diabetes and HbA1C 9. CKD follow-up |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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