Abstract
Background
The objective of this pilot study was to evaluate the feasibility and safety of natural orifice endoscopic transanal total mesorectal excision (TME) with laparoscopic assistance in a cohort study of five patients with stage I and IIA rectal cancer.
Methods
Five eligible patients with node-negative rectal cancer located 4–12 cm from the anal verge were enrolled in an IRB-approved pilot study. All patients underwent transanal endoscopic TME with laparoscopic assistance, hand-sewn coloanal anastomosis, and a diverting loop ileostomy. Primary and secondary end points included adequacy of the mesorectal excision and 30-day postoperative complications, respectively.
Results
Between November 2011 and May 2012, three males and two females underwent transanal endoscopic TME with laparoscopic assistance. Patient mean age and BMI were 48.6 ± 9.8 years and 25.7 ± 2.3 kg/m2, respectively. Tumors were located an average of 5.7 ± 2.4 cm from the anal verge and preoperatively staged as T1N0M0 (2), T2N0M0 (1), and T3N0M0 (2). Mean operative time was 274.6 ± 85.4 min with no intraoperative complications. Partial intersphincteric resection was performed in conjunction with transanal endoscopic TME in three patients. Pathologic examination of TME specimens demonstrated complete mesorectal excision in all cases with negative proximal, distal, and radial margins. Mean length of hospital stay was 5.2 ± 2.6 days and three minor complications occurred, including one ileus and two cases of transient urinary dysfunction. At a mean early follow-up of 5.4 ± 2.3 months, all patients remain disease-free.
Conclusions
In this pilot study of five patients with rectal cancer, transanal endoscopic TME with laparoscopic assistance is feasible and safe, and is a promising alternative to open and laparoscopic TME. Evaluation of long-term functional and oncologic outcomes of this approach is needed before widespread adoption can be recommended.
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Acknowledgments
We acknowledge Dr. Allan Goldstein for his contribution as a medical monitor for the study. This study was funded by a Grant from the Center for Integration of Medicine and Innovative Technology (CIMIT), DoD award W82XWH-07-02-0011. This study is registered with www.clinicaltrials.gov as NCT01340755.
Disclosures
Dr. Patricia Sylla has received honoraria from Genzyme and Novatract Surgical for consulting and from Applied Medical for teaching. Dr. Liliana Bordeianou has received an honorarium from American Medical Systems for consulting. Dr. Gregory Lauwers has received an honorarium from Dako for consulting. Dr. Antonio Lacy has received honoraria from Covidien and Olympus Medical for consulting. Dr. David Rattner has received an honorarium from Olympus Medical for consulting. All these authors report that these financial relationships had no influence on the outcomes or content of this study. Drs. Berger, Han, Sahani, and Sbeih have no relevant financial interests to disclose.
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Sylla, P., Bordeianou, L.G., Berger, D. et al. A pilot study of natural orifice transanal endoscopic total mesorectal excision with laparoscopic assistance for rectal cancer. Surg Endosc 27, 3396–3405 (2013). https://doi.org/10.1007/s00464-013-2922-7
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DOI: https://doi.org/10.1007/s00464-013-2922-7