Rectal Surgery Evaluation Trial (RESET)

Korábbi kezelés

• Patient requires an abdominal perineal resection (APR)
• Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections)
• Patient included in another study which impact on the surgical technique or its choice.

Más betegség

• Patient with a comorbid illness or condition that would preclude the use of surgery.
• Patients with concurrent or previous invasive pelvic malignant tumors (cervical, uterine, or rectal; excluding the prostate) within 5 years before study enrollment
• Metastatic disease

Egyéb

• Patients with T4b tumors which impose a pelvectomy
• Patient undergoing emergency procedures
• Pregnant or suspected pregnancy
• Patients unwilling to comply with all follow-up study requirements

• Age ≥ 18 years old
• Rectal adenocarcinoma from middle and lower third (less than 10 cm from the anal verge) with a sphincter saving procedure
• High risk operative patients (two of these factors as assessed on MRI):
  • Obese patient with a BMI > 30 (male or female)
  • Narrow pelvis: inter-tuberous distance < 10 cm
  • Large tumoral volume with suspicion of close predictive margin (CRM ≤ 1 mm) at diagnosis
  • Expected coloanal or ultra-low colorectal anastomosis
• Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2)
• Patient has signed and dated the informed consent before inclusion in the study.