Clinical trial NCT02550769: Study of NOTES-TME Versus L-LAR in Rectal Cancer
Official title: Multicenter Prospective Randomized Controlled Study of the Transanal Total Mesorectal Excision Versus Laparoscopic Low Anterior Resection in Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: Transanal NOTES
Transanal TME
Laparoscopic Low Anterior Resection
Surgery
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the effectiveness of the T-TME versus L-LAR with the Dindo-Claviens classification in patients with rectal cancer.
timeFrame: 30 days
measure: 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.
timeFrame: 6 months
measure: Evaluate the effectiveness of the T-TME versus L-LAR with the EORTC QLQ-CR29 score in patients with rectal cancer.
timeFrame: 6 months
measure: Evaluate the effectiveness of the T-TME versus L-LAR with the LARS score in patients with rectal cancer.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Parc Tauli University Hospital
state: Barcelona
Study officials:
affiliation: Corporacio Parc Tauli. Parc Tauli University Hospital
name: Serra-Aracil Xavier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Serra-Aracil X, Mora-Lopez 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.
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. No abstract available. Spanish.
citation: Serra-Aracil X, Zarate A, Bargallo J, Gonzalez A, Serracant A, Roura J, Delgado S, Mora-Lopez L; Ta-LaTME study Group. Transanal versus laparoscopic total mesorectal excision for mid and low rectal cancer (Ta-LaTME study): multicentre, randomized, open-label trial. Br J Surg. 2023 Jan 10;110(2):150-158. doi: 10.1093/bjs/znac324.
citation: Serra-Aracil X, Zarate A, Mora L, Serra-Pla S, Pallisera A, Bonfill J, Bargallo J, Pando A, Delgado S, Balleteros E, Pericay C. Study protocol for a multicenter prospective controlled and randomized trial of transanal total mesorectal excision versus laparoscopic low anterior resection in rectal cancer. Int J Colorectal Dis. 2018 May;33(5):649-655. doi: 10.1007/s00384-018-2996-8. Epub 2018 Mar 16.