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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Low Anterior Resection in Rectal Cancer

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: TRANSANAL TOTAL MESORECTAL EXCISION
* Procedure: Laparoscopic-LAR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRANSANAL TOTAL MESORECTAL EXCISION<br>Transanal approach of total mesorectal excision. | Procedure: TRANSANAL TOTAL MESORECTAL EXCISION<br>* The technique begins with the TEO equipment and a purse string 1 cm distal to the tumor. The dissection progresses in the posterior part until the laparoscopic TME field is reached. After the section of the rectum and TME transanal dissection, the anvil of the circular mechanical stapler is introduced through the TEO rectoscope. In the laparoscopic field, the mesosigma is sectioned at the point where the colon section is to be performed. The TEO rectoscope is withdrawn, and the bag containing the specimen is removed through the anus. The stapler is inserted. From the laparoscopic field, the strings of the purse are tightened and the purse is closed around the rectal stump with a clip. Then the stapler are joined to perform the anastomosis and a loop ileostomy is placed in the right flank.<br>|
| Active Comparator: Laparoscopic-LAR<br>Type of surgical intervention as control group: Laparoscopic low anterior resection with total mesorectal excision for rectal cancer | Procedure: Laparoscopic-LAR<br>* Standard laparoscopic low anterior resection of the rectum with total mesorectal excision and colorectal anastomosis<br>* Other names: Laparoscopic Low Anterior Resecion of the rectum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effectiveness of the T-TME versus L-LAR with the Dindo-Claviens classification in patients with rectal cancer. | Evaluate surgical complications 30 days after surgery. | 30 days | 
| 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. | Evaluate functional results 6 months after ileostomy closure. | 6 months | 
| Evaluate the effectiveness of the T-TME versus L-LAR with the EORTC QLQ-CR29 score in patients with rectal cancer. | Evaluate functional results 6 months after ileostomy closure. | 6 months | 
| Evaluate the effectiveness of the T-TME versus L-LAR with the LARS score in patients with rectal cancer. | Evaluate functional results 6 months after ileostomy closure. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transanal NOTES, Transanal TME, Laparoscopic Low Anterior Resection, Surgery