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

Not Applicable

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: TRANSANAL TOTAL MESORECTAL EXCISION; Procedure: Laparoscopic-LAR

• Registration Number: NCT02550769
• Lead Sponsor: Corporacion Parc Tauli

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-16
• Primary Completion: 2016-05
• Status Verified: 2020-07
• Study Completion: 2021-06
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRANSANAL TOTAL MESORECTAL EXCISION	TRANSANAL TOTAL MESORECTAL EXCISION	Transanal approach of total mesorectal excision.
Laparoscopic-LAR	Laparoscopic-LAR	Type of surgical intervention as control group: Laparoscopic low anterior resection with total mesorectal excision for rectal cancer

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of the T-TME versus L-LAR with the LARS score in patients with rectal cancer.	6 months	Evaluate functional results 6 months after ileostomy closure.
Evaluate the effectiveness of the T-TME versus L-LAR with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CR-30 score in patients with rectal cancer.	6 months	Evaluate functional results 6 months after ileostomy closure.
Evaluate the effectiveness of the T-TME versus L-LAR with the Dindo-Claviens classification in patients with rectal cancer.	30 days	Evaluate surgical complications 30 days after surgery.
Evaluate the effectiveness of the T-TME versus L-LAR with the EORTC QLQ-CR29 score in patients with rectal cancer.	6 months	Evaluate functional results 6 months after ileostomy closure.

Trial Locations

Locations (1)

Parc Tauli University Hospital; 🇪🇸 Sabadell, Barcelona, Spain