Study of NOTES-TME Versus L-LAR in Rectal Cancer (NOTESvsL-LAR)

Corporacion Parc Tauli

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: TRANSANAL TOTAL MESORECTAL EXCISION; Procedure: Laparoscopic-LAR

Study type: Interventional

Funder types: Other

Identifiers

NCT02550769

NOTES-LRAB_TAU-2015

Details and patient eligibility

About

INTRODUCTION: 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 with rectal cancer that, 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 sample calculation is 58 patients per group.

Full description

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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

TRANSANAL TOTAL MESORECTAL EXCISION

Experimental group

Description:

Transanal approach of total mesorectal excision.

Treatment:

Procedure: TRANSANAL TOTAL MESORECTAL EXCISION

Laparoscopic-LAR

Active Comparator group

Description:

Type of surgical intervention as control group: Laparoscopic low anterior resection with total mesorectal excision for rectal cancer

Treatment:

Procedure: Laparoscopic-LAR