Study of NOTES-TME Versus L-LAR in Rectal Cancer

INTRODUCTION: The laparoscopic total mesorectal excision (TME) has provided better patient recovery with less morbidity and shorter hospital stay compared with open surgery. However in laparoscopic low rectal surgery, overall conversion to open surgery is around 20%. Transanal TME (T-TME) combined with laparoscopy, called hybrid-NOTES, is a less invasive procedure that responds to some of the limitations of the rectal laparoscopic approach.

MAIN OBJECTIVE: To analyze that the T-TME gets a faster recovery due to a lower conversion rate to open surgery than laparoscopic low anterior resection (L-LAR) in rectal cancer with the same pathological, functional and oncologic results.

METHODOLOGY: A prospective multicenter randomized controlled study of patients diagnosed with adenocarcinoma of the rectum that after inclusion and exclusion criteria, were randomized in the T-TME- and L-LAR group. The main variables are: general morbidity, anastomotic dehiscence, conversion rate to open surgery and hospital stay. The other variables studied were: demographic, surgical, pathological, 30-day morbidity and mortality, quality of life and oncologic results. The sample calculation is 53 patients per group. With an estimated loss of 10%, the final number will be 116 patients.

Inclusion criteria

• Age over 18 years
• Patients with rectal cancer stage: cT1-2-3, cN0-1, cM0.
• Tumor equal or below 10 cm from the anal verge, candidates to (ETM) low anterior resection and anastomosis, with or without preoperative chemo-radiotherapy.
• Adenocarcinoma of low or moderate differentiation
• ASA I, II, III.

Exclusion criteria

• Do not sign informed consent
• Pregnant patients
• Liver cirrhosis
• Undifferentiated adenocarcinoma.
• cT4
• Metastatic disease (M1)
• chronic renal failure on dialysis
• ASA IV
• BMI <18 and> 35 kg / m2