CompletedNot Applicable

Efficiency of Two Dimensional High Definition vs Three Dimensional Endoscopic Systems in Transanal Endoscopic Surgery

Spain36 participantsStarted 2010-08

Plain-language summary

Introduction: The usual surgical technique for large adenomatous tumors and rectal cancer is anterior resection of the rectum or abdominoperineal resection. These techniques are associated with high mortality and morbidity and with genitourinary dysfunctions. To solve these problems, transanal endoscopic microsurgery (TEM) was designed. Through its 3-D vision system using a rectoscope, this procedure allows access to rectal tumors located up to 20 cm from the anal verge. It is associated with minimal morbidity and has few repercussions for anal continence. The use of 2-D high definition cameras and screens obtains images of a similar quality to 3-D images. This means that from the surgical point of view the procedure known as TEO (transanal endoscopic operation) seems as practicable as classic TEM. Main aim: To assess the effectiveness of 2-D high definition vision systems (TEO) versus conventional 3-D (TEM) in endoscopic surgery of rectal tumors, with respect to surgical facility, postoperative morbidity, quality of the surgical specimens, and cost. Design: Prospective, controlled, randomized study of the efficacy of the use of 2-D high definition endoscopic systems versus 3-D (TEM) in transanal endoscopic surgery. Disease studied: Rectal adenomas and adenocarcinomas "in situ" suitable for local surgery. Main variable evaluated: Cost per procedure assuming similar surgical efficacy and equal postoperative morbidity. Study population and total number of patients: Patients diagnosed with rectal tumor treated with curative intent (rectal adenomas and adenocarcinomas "in situ"). The total sample calculated for the trial was 36 patients, 18 in each group (TEO and TEM). Timing and expected finish date: After approval by the CEIC, the expected date for the inclusion of the first patient was August 2010. The study is expected to last 18-24 months.

Who can participate

Age range

18 Years – 90 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: * Patients of either sex older than 18 years * Rectal tumor identified as rectal adenoma by multifocal biopsy using colonoscopy, with endorectal ultrasound and magnetic resonance imaging findings of non-invasive tumor. * Size of the tumor between 2 and 6 cm in maximum diameter. * Tumor location, lower edge at least 2 cm from the anal verge, and upper edge at least 15 cm from the anal verge. * ASA score more than III. * intervention was performed under general anesthesia Exclusion Criteria: * Invasive adenocarcinoma shown in the final pathology study. "in situ" or intraepithelial adenocarcinomas are not excluded . * Pregnant patients * Patients with liver cirrhosis or blood dyscrasia. * Patients who can not be administered under general anesthesia. * Patients on antiplatelet or anticoagulation therapy who have not been properly prepared for surgery. * Presence of two or more transanal endoscopic excisions in the same procedure. * Informed consent not signed.

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

Cost per procedure assuming similar surgical efficacy and equal postoperative morbidity

Timeframe: 30 days

Trial details

NCT IDNCT01498354

SponsorCorporacion Parc Tauli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-10

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