CompletedNot Applicable

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

Spain116 participantsStarted 2015-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluate the effectiveness of the T-TME versus L-LAR with the Dindo-Claviens classification in patients with rectal cancer.

Timeframe: 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.

Timeframe: 6 months

Evaluate the effectiveness of the T-TME versus L-LAR with the EORTC QLQ-CR29 score in patients with rectal cancer.

Timeframe: 6 months

Evaluate the effectiveness of the T-TME versus L-LAR with the LARS score in patients with rectal cancer.

Timeframe: 6 months

Trial details

NCT IDNCT02550769

SponsorCorporacion Parc Tauli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05

View on ClinicalTrials.gov More Rectal Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Evaluate the effectiveness of the T-TME versus L-LAR with the Dindo-Claviens classification in patients with rectal cancer.

Timeframe: 30 days

Timeframe: 6 months

Evaluate the effectiveness of the T-TME versus L-LAR with the EORTC QLQ-CR29 score in patients with rectal cancer.

Timeframe: 6 months

Evaluate the effectiveness of the T-TME versus L-LAR with the LARS score in patients with rectal cancer.

Timeframe: 6 months