Prospective multicenter observational cohort to assess quality of life, cost-effectivity and functional outcomes following minimal invasive surgical techniques for rectal cancer in ‘dedicated centers’

Total mesorectal excision is the standard of care for rectal cancer, which can be performed using open, laparoscopic, robot-assisted, and transanal technique. Large prospective (randomized controlled) trials comparing these techniques are lacking, do not take into account the learning curve, and have short term or long-term oncological results as their primary endpoint, without addressing quality of life (QoL), cost-effectiveness (CE) and functional outcomes. Comparative data with regard to these outcomes is necessary to identify the optimal minimal invasive technique and provide guidelines for clinical application.

The Vantage trial will be a prospective observational multicenter cohort trial, aiming to compare laparoscopic (L-TME), robot-assisted (R-TME) and transanal (TaTME) total mesorectal excision in adult rectal cancer patients performed by experienced surgeons in dedicated centers. Data collection will be performed in collaboration with the prospective Dutch ColoRectal Audit and the Prospective Dutch ColoRectal Cancer Cohort. QoL at 1 year postoperatively will be the primary outcome. CE, functional outcomes, short term outcomes, and long-term oncological outcomes will be the secondary outcomes. In total, 1200 patients will be enrolled over a period of two years in twenty-six dedicated centers in the Netherlands.

Data will be collected through collaborating parties, who already obtained approval by their medical ethical committee. Participants will be included in the vantage trial after having signed informed consent. Results of this study will be disseminated to participating centers, patient organizations, (inter)national society meetings, and peer-reviewed journals.

QoL, CE and functional outcomes differ significantly between L-TME, R-TME and TaTME.

PLCRC will provide the current study with:
QoL outcomes, collected through the EORTC QoL Questionnaire-Core questionnaire (QLQ-C30) and EORTC QoL Questionnaire ColoRectal Cancer module (QLQ-CR29) sent at baseline, three, six, 12, 18 and 24 months postoperative.

CE outcomes, collected through the EQ-5D and WAI at baseline, three, six, 12, 18 and 24 months postoperative. And through the iMCQ at three, six, 12, 18 and 24 months postoperative.

Functional outcomes, collected through Low Anterior Resection Syndrome (LARS) Questionnaire, Macoy Female Sexuality Questionnaire (MFSQ), International Index of Erectile Function (IIEF), Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) sent at baseline, three, six, 12, 18 and 24 months postoperative.

The DCRA will provide the current study with:
Short term outcomes and baseline characteristics, collected at 90 days postoperative, including patient, imaging, perioperative and histopathological characteristics.

Additionally, Vantage will collect data not provided by DCRA and PLCRC: imaging characteristics (sigmoidal take-off, low rectal tumors defined according to the LOREC definition, ycTNM staging) and long term oncological and stoma outcomes (complications, anastomotic leakage (significant for CE and QoL)).

Not applicable.