Galaal 2019 (TIC TOC).
Study characteristics | ||
Methods |
Design: RCT, parallel two‐arm, multicentre feasibility study Setting: four UK NHS hospitals (3 university teaching hospitals, 1 district general hospital) Recruitment: July 2016 to June 2018 (study dates) Maximum follow‐up: not reported |
|
Participants | Adult women requiring primary or interval surgery for suspected ovarian cancer (Figo III/IV or primary peritoneal cancer) were randomised to one of the following two groups: Intraoperative cell salvage (Cell salvage/intervention group) Donor blood transfusion (Control/no cell salvage group) The authors do not report a between‐group comparison at baseline and no demographic data are provided. |
|
Interventions |
Intraoperative cell salvage (Cell salvage/intervention group): intraoperative cell salvage was used to salvage intraoperative blood, which was subsequently processed prior to autotransfusion. As cell saver machines varied between participating sites, no specific device is named. Donor blood transfusion (Control/no cell salvage group): participants in the donor blood group were considered for transfusion according to clinical judgement and local hospital policy |
|
Outcomes | Outcomes reported: mortality, cancer recurrence, inadvertent visceral injury (bladder, bowel, ureters, blood vessels, nerve), return to theatre within 48 hours, surgical site infection (see online supplementary appendix 4) within 30 days, thromboembolic complications (DVT, PE) within 30 days, number and nature of adverse events, amount of donor blood given (total and ≤ 24 hours postsurgery), length of hospital stay, resource use, generic quality of life (QOL) measure: EQ‐5D‐5L, cancer‐specific QOL measure: EORTC QLQ‐C30 (Version 3.0) (confirmed cancer only), ovarian cancer QOL measure: EORTC QLQ‐OV28 (confirmed cancer only) | |
Notes | Full results for this study are not available. We extracted data from a conference abstract; we extracted methods from the published protocol and trial registration Transfusion protocol: all sites followed a common intraoperative cell salvage protocol and donor transfusion was considered during surgery in accordance with clinical judgement, guided by local hospital policy. No further details with regards to the study's transfusion protocol or local hospital policy are available. Prospective registration status: the study was prospectively registered with a trials registry (ISRCTN19517317). Ethical approval: ethical approval was granted by the South West Exeter Research Ethics Committee (ref: 16/SW/0256). Language of publication: English Trial funding: National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) programme grant (PB‐PG‐1014‐35005). Conflicts of interest: none declared |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients will be randomised to either group using a web‐based randomisation system. Randomisation will be performed using random permuted blocks of varying size in a 1:1 allocation ratio, stratified by study site. Randomisation will be performed as close as possible to the time of surgery." |
Allocation concealment (selection bias) | Low risk | Quote: "Randomisation will be achieved by means of a web‐based system created by the UK Clinical Research Collaboration‐registered Peninsula Clinical Trials Unit (CTU) in conjunction with the trial statistician, using random permuted blocks of varying size." |
Blinding of participants and personnel (performance bias) Objective outcome: mortality | Low risk | Objective outcome (mortality) unlikely to be influenced by blinding |
Blinding of participants and personnel (performance bias) Subjective: transfusion protocol | High risk | Transfusion according to local protocol but guided by clinical judgement |
Blinding of participants and personnel (performance bias) Subjective: all other outcomes | High risk | Surgeons, other theatre staff, and the person recording details of intraoperative blood transfusion or re‐infusion could not be blinded in this study. |
Blinding of outcome assessment (detection bias) Objective outcomes: mortality and transfusions | Low risk | Objective outcome (mortality) unlikely to be influenced by blinding |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Quote: "The research nurse responsible for recording postoperative outcomes will aim to remain blinded to treatment allocation." Unclear if this remained the case |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Protocol published and initial results presented as a conference abstract only with no information regarding patient flow. |
Selective reporting (reporting bias) | Unclear risk | Protocol published, initial results presented as a conference abstract only (limited results reported) |
Other bias | Unclear risk | Conference abstract only ‐ does not comment on baseline characteristics or funding. Authors state no conflicts of interest to disclose |