Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol
Introduction Despite 40 randomised controlled trials (RCTs) investigating preoperative oral antibiotics (OA) and mechanical bowel preparation (MBP) to reduce surgical site infection (SSI) rate following colon surgery, there has never been an RCT published comparing OA alone versus no preparation. Of...
Saved in:
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2020-07-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/7/e036866.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850137894281281536 |
|---|---|
| author | Dean A Fergusson Kednapa Thavorn Rebecca C Auer Husein Moloo Sameer S Apte Ahwon Jeong Michelle Liu Lisa Vandemeer Kathryn Suh Mark Clemons |
| author_facet | Dean A Fergusson Kednapa Thavorn Rebecca C Auer Husein Moloo Sameer S Apte Ahwon Jeong Michelle Liu Lisa Vandemeer Kathryn Suh Mark Clemons |
| author_sort | Dean A Fergusson |
| collection | DOAJ |
| description | Introduction Despite 40 randomised controlled trials (RCTs) investigating preoperative oral antibiotics (OA) and mechanical bowel preparation (MBP) to reduce surgical site infection (SSI) rate following colon surgery, there has never been an RCT published comparing OA alone versus no preparation. Of the four possible regimens (OA alone, MBP alone, OA plus MBP and no preparation), randomised evidence is conflicting for studied groups. Furthermore, guidelines vary, with recommendations for OA alone, OA plus MBP or no preparation. The National Surgical Quality Improvement Program (NSQIP) has automated data collection for surgical patients. Similarly, the ‘REthinking Clinical Trials’ (REaCT) platform increases RCT enrolment by simplifying pragmatic trial design. In this novel RCT protocol, we combine REaCT and NSQIP to compare OA alone versus no preparation for SSI rate reduction in elective colon surgery. To our knowledge, this is the first published RCT protocol that leverages NSQIP for data collection. In our feasibility study, 67 of 74 eligible patients (90%) were enrolled and 63 of 67 (94%) were adherent to protocol. The ‘REaCT–NSQIP’ trial design has great potential to efficiently generate level I evidence for other perioperative interventions.Methods and analysis SSI rates following elective colorectal surgery after preoperative OA or no preparation will be compared. We predict 45% relative rate reduction of SSI, improvement in length of stay, reduced costs and increased quality of life, with similar antibiotic-related complications. Consent, using the ‘integrated consent model’, and randomisation on a mobile device are completed by the surgeon in a single clinical encounter. Data collection for the primary end point is automatic through NSQIP. Analysis of cost per weighted case, cost utility and quality-adjusted life years will be done.Ethics and dissemination This study is approved by The Ontario Cancer Research Ethics Board. Results will be disseminated in surgical conferences and peer-reviewed journals.Trial registration number NCT03663504; Pre-results, recruitment phase. |
| format | Article |
| id | doaj-art-189e931b02d64308b5d6f357787b0f70 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-189e931b02d64308b5d6f357787b0f702025-08-20T02:30:43ZengBMJ Publishing GroupBMJ Open2044-60552020-07-0110710.1136/bmjopen-2020-036866Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocolDean A Fergusson0Kednapa Thavorn1Rebecca C Auer2Husein Moloo3Sameer S Apte4Ahwon Jeong5Michelle Liu6Lisa Vandemeer7Kathryn Suh8Mark Clemons9Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, ON, CanadaSchool of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, CanadaCancer Research Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaFaculty of Medicine, The University of Ottawa, Ottawa, Ontario, CanadaDepartment of Surgery, The Ottawa Hospital, Ottawa, Ontario, CanadaCancer Therapeutics Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaCancer Therapeutics Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaCancer Therapeutics Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, CanadaFaculty of Medicine, The University of Ottawa, Ottawa, Ontario, CanadaFaculty of Medicine, The University of Ottawa, Ottawa, Ontario, CanadaIntroduction Despite 40 randomised controlled trials (RCTs) investigating preoperative oral antibiotics (OA) and mechanical bowel preparation (MBP) to reduce surgical site infection (SSI) rate following colon surgery, there has never been an RCT published comparing OA alone versus no preparation. Of the four possible regimens (OA alone, MBP alone, OA plus MBP and no preparation), randomised evidence is conflicting for studied groups. Furthermore, guidelines vary, with recommendations for OA alone, OA plus MBP or no preparation. The National Surgical Quality Improvement Program (NSQIP) has automated data collection for surgical patients. Similarly, the ‘REthinking Clinical Trials’ (REaCT) platform increases RCT enrolment by simplifying pragmatic trial design. In this novel RCT protocol, we combine REaCT and NSQIP to compare OA alone versus no preparation for SSI rate reduction in elective colon surgery. To our knowledge, this is the first published RCT protocol that leverages NSQIP for data collection. In our feasibility study, 67 of 74 eligible patients (90%) were enrolled and 63 of 67 (94%) were adherent to protocol. The ‘REaCT–NSQIP’ trial design has great potential to efficiently generate level I evidence for other perioperative interventions.Methods and analysis SSI rates following elective colorectal surgery after preoperative OA or no preparation will be compared. We predict 45% relative rate reduction of SSI, improvement in length of stay, reduced costs and increased quality of life, with similar antibiotic-related complications. Consent, using the ‘integrated consent model’, and randomisation on a mobile device are completed by the surgeon in a single clinical encounter. Data collection for the primary end point is automatic through NSQIP. Analysis of cost per weighted case, cost utility and quality-adjusted life years will be done.Ethics and dissemination This study is approved by The Ontario Cancer Research Ethics Board. Results will be disseminated in surgical conferences and peer-reviewed journals.Trial registration number NCT03663504; Pre-results, recruitment phase.https://bmjopen.bmj.com/content/10/7/e036866.full |
| spellingShingle | Dean A Fergusson Kednapa Thavorn Rebecca C Auer Husein Moloo Sameer S Apte Ahwon Jeong Michelle Liu Lisa Vandemeer Kathryn Suh Mark Clemons Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol BMJ Open |
| title | Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol |
| title_full | Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol |
| title_fullStr | Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol |
| title_full_unstemmed | Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol |
| title_short | Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol |
| title_sort | prospective randomised controlled trial using the rethinking clinical trials react platform and national surgical quality improvement program nsqip to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery a protocol |
| url | https://bmjopen.bmj.com/content/10/7/e036866.full |
| work_keys_str_mv | AT deanafergusson prospectiverandomisedcontrolledtrialusingtherethinkingclinicaltrialsreactplatformandnationalsurgicalqualityimprovementprogramnsqiptocomparenopreparationversuspreoperativeoralantibioticsaloneforsurgicalsiteinfectionratesinelectivecolonsurgeryaprotocol AT kednapathavorn prospectiverandomisedcontrolledtrialusingtherethinkingclinicaltrialsreactplatformandnationalsurgicalqualityimprovementprogramnsqiptocomparenopreparationversuspreoperativeoralantibioticsaloneforsurgicalsiteinfectionratesinelectivecolonsurgeryaprotocol AT rebeccacauer prospectiverandomisedcontrolledtrialusingtherethinkingclinicaltrialsreactplatformandnationalsurgicalqualityimprovementprogramnsqiptocomparenopreparationversuspreoperativeoralantibioticsaloneforsurgicalsiteinfectionratesinelectivecolonsurgeryaprotocol AT huseinmoloo prospectiverandomisedcontrolledtrialusingtherethinkingclinicaltrialsreactplatformandnationalsurgicalqualityimprovementprogramnsqiptocomparenopreparationversuspreoperativeoralantibioticsaloneforsurgicalsiteinfectionratesinelectivecolonsurgeryaprotocol AT sameersapte prospectiverandomisedcontrolledtrialusingtherethinkingclinicaltrialsreactplatformandnationalsurgicalqualityimprovementprogramnsqiptocomparenopreparationversuspreoperativeoralantibioticsaloneforsurgicalsiteinfectionratesinelectivecolonsurgeryaprotocol AT ahwonjeong prospectiverandomisedcontrolledtrialusingtherethinkingclinicaltrialsreactplatformandnationalsurgicalqualityimprovementprogramnsqiptocomparenopreparationversuspreoperativeoralantibioticsaloneforsurgicalsiteinfectionratesinelectivecolonsurgeryaprotocol AT michelleliu prospectiverandomisedcontrolledtrialusingtherethinkingclinicaltrialsreactplatformandnationalsurgicalqualityimprovementprogramnsqiptocomparenopreparationversuspreoperativeoralantibioticsaloneforsurgicalsiteinfectionratesinelectivecolonsurgeryaprotocol AT lisavandemeer prospectiverandomisedcontrolledtrialusingtherethinkingclinicaltrialsreactplatformandnationalsurgicalqualityimprovementprogramnsqiptocomparenopreparationversuspreoperativeoralantibioticsaloneforsurgicalsiteinfectionratesinelectivecolonsurgeryaprotocol AT kathrynsuh prospectiverandomisedcontrolledtrialusingtherethinkingclinicaltrialsreactplatformandnationalsurgicalqualityimprovementprogramnsqiptocomparenopreparationversuspreoperativeoralantibioticsaloneforsurgicalsiteinfectionratesinelectivecolonsurgeryaprotocol AT markclemons prospectiverandomisedcontrolledtrialusingtherethinkingclinicaltrialsreactplatformandnationalsurgicalqualityimprovementprogramnsqiptocomparenopreparationversuspreoperativeoralantibioticsaloneforsurgicalsiteinfectionratesinelectivecolonsurgeryaprotocol |