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

Rectal Cancer Clinical Trial

— NOTESvsL-LAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02550769
• Other study ID #: NOTES-LRAB_TAU-2015
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: June 2021

Study information

• Verified date: July 2020
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: June 2021
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• TRANSANAL TOTAL MESORECTAL EXCISION
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.
• Laparoscopic-LAR
Standard laparoscopic low anterior resection of the rectum with total mesorectal excision and colorectal anastomosis

Locations

Country	Name	City	State
Spain	Parc Tauli University Hospital	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Serra-Aracil X, Mora-López L, Casalots A, Pericay C, Guerrero R, Navarro-Soto S. Hybrid NOTES: TEO for transanal total mesorectal excision: intracorporeal resection and anastomosis. Surg Endosc. 2016 Jan;30(1):346-54. doi: 10.1007/s00464-015-4170-5. Epub 2015 Mar 27. — View Citation

Serra-Aracil X. [Transanal total mesorectal excision]. Cir Esp. 2014 Apr;92(4):221-2. doi: 10.1016/j.ciresp.2014.01.002. Epub 2014 Feb 24. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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