Prospective multicenter observational cohort study evaluating cost-effectiveness, quality of life, and functional outcomes after minimally invasive surgical treatment of rectal cancer in expert centers.

Rationale

The surgical treatment of rectal cancer typically involves minimally invasive total mesorectal excision (TME), performed using laparoscopic, robot-assisted, or transanal approaches. While robot-assisted and transanal TME are likely more costly, these techniques may lead to better outcomes, such as higher rates of primary anastomosis and fewer permanent stomas. However, their true impact on cost and patient-reported outcomes remains unclear. Existing trials are limited: they often lack sufficient size, do not account for the learning curve, and mainly focus on short-term or oncological outcomes without addressing cost-effectiveness, quality of life, or functional outcomes. The VANTAGE study is designed to close this gap by systematically evaluating these aspects across the three main minimally invasive techniques.

Study design

The VANTAGE study is a prospective multicenter cohort study conducted in Dutch expert centers, where surgeons have completed the learning curve for minimally invasive TME. Patients undergoing laparoscopic, robot-assisted, or transanal TME are asked to complete questionnaires at baseline, and at 3, 6, 9, 12, 18, 24 and 36 months. Data collection will take place in collaboration with the Prospective Dutch ColoRectal Cancer Cohort (PLCRC). PLCRC collects validated questionnaires on cost-effectiveness (iMCQ, WAI), quality of life (QLQ-C30, QLQ-CR29), sexual function (MFSQ, IIEF), and continence (UDI-6, IIQ-7). In addition, VANTAGE researchers will gather supplementary baseline characteristics, imaging data, short-term surgical and long-term oncological and stoma (complication) data. Between July 2021 and July 2025, 1,200 patients will be included

• Inclusion criteria: Adults (≥18 years) with rectal cancer, defined as tumors with a lower margin below the sigmoidal take-offUndergoing elective, curative laparoscopic, robot-assisted, or transanal TME in dedicated expert centers
• Primary outcome: Quality of life, based on Physical Functioning scores of the EORTC QLQ-C30 and QLQ-CR29 questionnaire
• Secondary outcomes: Amongst others functional outcomes (bowel, urinary and sexual function), Cost-effectiveness, Short- and long-term complications, including stoma-related complications

Funding

The VANTAGE study is supported by: 

• ZonMw Program for Efficiency Studies (DoelmatigheidsOnderzoek), Open Round 2023 – project number 2403434
• Intuitive Surgical – unrestricted research grant of USD $60,000 (grant number V20201105)