Citations 3
Secondary analysis of data from the HeLiX trial regarding the association between estimated blood loss and post-hepatectomy outcomes: towards the definition of a minimal clinically significant difference
Hallet, Julie , Ribeiro, Tiago C. , Perri, Giampaolo , Ghorbani, Poya , Sparrelid, Ernesto , Marchegiani, Giovanni , Karanicolas, Paul J. , Team, the HPB CONCEPT, Lin, Yulia , McCluskey, Stuart A. , Tarshis, Jordan , Dixon, Elijah , Porter, Geoff , Chaudhury, Prosanto , Nanji, Sulaiman , Ruo, Leyo , Skaro, Anton , Eeson, Gareth, Moulton, Carol-Anne, Bal, Chad G, Coburn, Natalie G. , Serrano, Pablo E, Jayaraman, Shiva , Law, Calvin, Tandan, Ved, Nagorney, David M. , Quan, Douglas , Smoot, Rory L., Gallinger, Steven, Metrakos, Peter, Reichman, Trevor , Jalink, Diederick, Bennett, Sean, Sutherland, Francis, Solano, Edward, Molinari, Michele , Tang, Ephraim , Warner, Susanne G, Bathe, Oliver F. , Barkun, Jeffrey , Kendrick, Michael L. , Truty, Mark J. , Roke, Rachel , Xu, Grace , Fong, Zhi V, Perri, Giampaolo , Marchegiani, Giovanni , Karanicolas, Paul Jack , Ribeiro, Tiago, Fong, Zhi Ven , Team, the HPB CONCEPT, Thorpe, Kevin E. , Wei, Alice C. , Tsang, Melanie E. , Cleary, Sean P. , Bal, Chad G, Serrano, Pablo E , Sapisochín, Gonzalo , Warner, Susanne G. , Lafrenière‐Roula, Myriam , Guyatt, Gordon
British Journal of Surgery | November 11, 2025 | Volume: 112 | Issue: 11 | Pages: No page available
Clinical evaluation of adults undergoing elective surgery utilizing intraoperative incisional wound irrigation (CLEAN Wound): protocol for a randomised controlled trial
Roke, Rachel , Lillie, Erin , Daneman, Nick , Mason, Stephanie, Jiang, Yidi , Shiroky, Jonah , Puran, Sudarshani, Smith, David E. , Khalil, Jad Abou, Kayssi, Ahmed , Pinchuk, Brian, Apte, Sameer , Lamb, Tyler , Ma, Grace , Vogt, Kelly, Leslie, Kenneth , Mutabdzic, Dorotea, Gómez, David , Ladha, Karim S. , Bennett, Sean, Ullah, Shahnoor M, Holland, Jessica, Smith, Andrew J., Calderone, Michael, Herriott, Judith, Voltan, Ed, Sloan, B., Mazer, C. David , Kennedy, Erin, Aarts, Mary-Anne, Karanicolas, Paul J. , Kayssi, Ahmed , Apte, Sameer S , Lamb, Tyler , Delisle, Megan , Muaddi, Hala , Fergusson, Dean A , Marshall, John C. , Karanicolas, Paul Jack , Tomlinson, George , Serrano, Pablo E , Vogt, Kelly, Tsang, Melanie E. , Ullah, Shahnoor M, Nathens, Avery B.
BMJ Open | July 17, 2025 | Volume: 15 | Issue: 7 | Pages: e104375
Introduction In moderate to high-risk surgical procedures, 15–25% of patients develop a postoperative surgical site infection. Intraoperative incisional wound irrigation has the potential to reduce surgical site infections, and additional randomised controlled trials are required to provide evidence of effectiveness. Methods and analysis This protocol describes a pragmatic, adaptive, participant and adjudicator-blinded trial at 13 sites in Canada in up to 2500 participants. Participants planned for surgery with an abdominal or groin incision, who are eligible and provide verbal consent through an integrated consent model, are randomised to receive intraoperative incisional wound irrigation with povidone-iodine, saline or no irrigation. The primary outcome is surgical site infection within 30 days postoperatively. Secondary outcomes include quality of life measured 30 days postoperatively and morbidity, mortality and healthcare utilisation within 90 days postoperatively. Ethics and dissemination This trial has been approved by the research ethics board at the participating centres and stopped enrolling participants on May 23, 2025. All participants will provide verbal consent. Results will be disseminated via presentation at conferences, publication and posted on clinicaltrials.gov. Trial registration number The study is registered with http://clinicaltrial.gov ( NCT04548661 ; 14 September 2020).
Tranexamic Acid in Patients Undergoing Liver Resection
Karanicolas, Paul J. , Lin, Yulia , McCluskey, Stuart A. , Tarshis, Jordan , Dixon, Elijah , Porter, Geoff , Chaudhury, Prosanto , Nanji, Sulaiman , Ruo, Leyo , Tsang, Melanie E. , Skaro, Anton , Eeson, Gareth, Moulton, Carol-Anne, Ball, Chad G. , Hallet, Julie, Coburn, Natalie, Jayaraman, Shiva, Law, Calvin, Tandan, Ved, Nagorney, David, Quan, Douglas , Smoot, Rory L. , Gallinger, Steven, Metrakos, Peter , Reichman, Trevor , Jalink, Diederick, Bennett, Sean, Sutherland, Francis, Solano, Edward, Molinari, Michele , Tang, Ephraim , Bathe, Oliver F. , Barkun, Jeffrey , Kendrick, Michael L., Truty, Mark J. , Roke, Rachel , Xu, Grace , Lafrenière‐Roula, Myriam , Team, HPB CONCEPT, Truty, Mark, Smoot, Rory L , Thorpe, Kevin E. , Wei, Alice C. , Cleary, Sean P. , Serrano, Pablo E , Sapisochín, Gonzalo , Warner, Susanne G. , Kendrick, Michael L. , Guyatt, Gordon , Team, HPB CONCEPT
JAMA | August 19, 2024 | Volume: 332 | Issue: 13 | Pages: 1080
ImportanceTranexamic acid reduces bleeding and blood transfusion in many types of surgery, but its effect in patients undergoing liver resection for a cancer-related indication remains unclear.ObjectiveTo determine whether tranexamic acid reduces red blood cell transfusion within 7 days of liver resection.Design, Setting, and ParticipantsMulticenter randomized clinical trial of tranexamic acid vs placebo conducted from December 1, 2014, to November 8, 2022, at 10 hepatopancreaticobiliary sites in Canada and 1 site in the United States, with 90-day follow-up. Participants, clinicians, and data collectors were blinded to allocation. A volunteer sample of 1384 patients undergoing liver resection for a cancer-related indication met eligibility criteria and consented to randomization.InterventionsTranexamic acid (1-g bolus followed by 1-g infusion over 8 hours; n = 619) or matching placebo (n = 626) beginning at induction of anesthesia.Main Outcomes and MeasuresThe primary outcome was receipt of red blood cell transfusion within 7 days of surgery.ResultsThe primary analysis included 1245 participants (mean age, 63.2 years; 39.8% female; 56.1% with a diagnosis of colorectal liver metastases). Perioperative characteristics were similar between groups. Red blood cell transfusion occurred in 16.3% of participants (n = 101) in the tranexamic acid group and 14.5% (n = 91) in the placebo group (odds ratio, 1.15 [95% CI, 0.84-1.56]; P = .38; absolute difference, 2% [95% CI, −2% to 6%]). Measured intraoperative blood loss (tranexamic acid, 817.3 mL; placebo, 836.7 mL; P = .75) and total estimated blood loss over 7 days (tranexamic acid, 1504.0 mL; placebo, 1551.2 mL; P = .38) were similar between groups. Participants receiving tranexamic acid experienced significantly more complications compared with placebo (odds ratio, 1.28 [95% CI, 1.02-1.60]; P = .03), with no significant difference in venous thromboembolism (odds ratio, 1.68 [95% CI, 0.95-3.07]; P = .08).Conclusions and RelevanceAmong patients undergoing liver resection for a cancer-related indication, tranexamic acid did not reduce bleeding or blood transfusion but increased perioperative complications.Trial RegistrationClinicalTrials.gov Identifier: NCT02261415