Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol in Lower Gastrointestinal Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,050
- Locations
- 80
- Primary Endpoint
- The incidence of 60-day predefined (according EPCO guidelines) postoperative complications following elective lower gastrointestinal surgery within any compliance of an ERAS protocol.
Study Overview
Brief Summary
Short title POWER Audit
Methods 60 days national (Spain) audit of postoperative complications following elective gastrointestinal surgery within an enhanced recovery after surgery (ERAS) protocol.
Research sites Hospitals undertaking elective lower gastrointestinal surgery. Objective To provide detailed data describing post-operative complications and associated mortality; and length of stay.
To provide detailed data describing adherence to ERAS protocol and its association to morbidity.
Number of patients Not specified. All eligible patients undergoing surgery during the study month. Inclusion Criteria All adult patients (aged ≥18 years) undergoing lower gastrointestinal elective surgery within an ERAS protocol during the 60 day study period.
Statistical analysis Univariate analysis will be used to test factors (patient, surgical, and ERAS related) associated with surgical complications, length of stay (LOS) and in-hospital death. Single and multi-level logistic regression models will be constructed to identify factors independently associated with these outcomes and to adjust for differences in confounding factors. A stepwise approach will be used to enter new terms. A single final analysis is planned at the end of the study.
Summary statistics with post hoc Bonferroni corrections will be used to assess possible dose-response dependence in percentage of patients with postoperative complications and LOS.
Proposed Start Date A 60 day period between 2017
Proposed End Date
Data collection will end by September 2017
Study Duration Six months
Detailed Description
Study data Data will be collected on all eligible patients who undergo elective lower gastrointestinal surgery within any compliance of an ERAS protocol during the study months. Only routine clinical data will be included and where this is unavailable the domain will be left blank e.g. patients who do not require blood tests. It is possible that regional groups may supplement their core data set with a very limited number of additional variables if these can be accommodated within the two page case record form (CRF) and they comply with regulations applied to this study.
Data collection Data will be collected in individual hospitals on a paper CRF for each patient recruited. Paper CRFs will be stored within a locked office in each centre. This will include identifiable patient data in order to allow follow-up of clinical outcomes. Data will then be pseudo-anonymised by generating a unique numeric code and transcribed by local investigators onto an internet based electronic CRF. Each patient will only be identified on the electronic CRF (eCRF) by their numeric code. Thus the co- ordinating study team cannot trace data back to an individual patient without contact with the local team. A patient list will be used in each centre to match identifier codes in the database to individual patients in order to record clinical outcomes and supply any missing data points. Once the local co-ordinator confirms data entry is complete for their hospital they will receive a spreadsheet of raw (un-cleaned) data, allowing further checks for data completeness and accuracy.
Audit organisation
POWER will be led by the study management group who will be responsible for study administration, communication between project partners, data collation and data management. Regional co-ordinators will lead the project in each Spanish region and:
- Identify local co-ordinators in participating hospitals
- Assist with translation of study paperwork as required
- Ensure distribution of study paperwork and other materials
- Ensure necessary regulatory approvals are in place prior to the start date
- Ensure good communication with the participating sites in his/her region
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All adult patients (aged ≥18 years) undergoing elective lower gastrointestinal surgery within any compliance of an ERAS protocol (including patients with 0 compliance) in a participating hospital during the 60-day cohort period with a planned overnight stay.
- •SURGERY SCHEDULED IN THE INCLUSION CRITERIA
- •Right hemicolectomy
- •Resection of transverse colon
- •Left hemicolectomy
- •Sigmoidectomy
- •Low anterior resection of the rectum
- •Abdominoperineal rectal amputation
- •Subtotal colectomy
- •Total colectomy
Exclusion Criteria
- •Patients undergoing emergency surgery
Outcomes
Primary Outcomes
The incidence of 60-day predefined (according EPCO guidelines) postoperative complications following elective lower gastrointestinal surgery within any compliance of an ERAS protocol.
Time Frame: 30 days
To confirm the incidence of 30-day in-hospital complications following elective in-patient surgery.
Secondary Outcomes
- 30-day in-hospital mortality associated with these complications(30 days)
Investigators
Javier Ripollés Melchor
Principal Investigator
Grupo Español de Rehabilitación Multimodal