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Sponsored by: |
Cantonal Hospital of St. Gallen |
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Information provided by: | Cantonal Hospital of St. Gallen |
ClinicalTrials.gov Identifier: | NCT00531297 |
Any efforts to spare patients with T1 carcinomas of the rectum from low anterior resection or even abdominoperineal resection are linked to the risk of locoregional recurrence of about 10% (range, 0-24). This is tolerated in the view of the morbidity and mortality risk related to transabdominal resection, which is as high as 7-68% and 0-6.5%, respectively. Accordingly, in addition to transanal local excision various adjuvant therapy schemes with chemo- and/or radiotherapy were developed, given the uncertainty about the lymph node stage. Another approach was to identify histological risk criteria in the primary tumor in terms of defining the limits of rectum-sparing therapy.
In earlier experimental and clinical studies we researched and applied dorsoposterior extraperitoneal pelviscopy, i.e. perineal access to the soft-tissue areas of the minor pelvis using minimally invasive surgery. in T1 carcinoma of the rectum this technique becomes all the more significant, as the perineal approach makes it possible to perform an endoscopic posterior mesorectal resection (EPMR) in combination with rectum-sparing surgery Thereby the relevant lymphatic field of the lower rectum can be removed and histologically examined. As a consequence EPMR should lower the loco-regional recurrence rate, since the most common causes of such are pre-existent but so far not detectable lymph node metastases besides the incomplete resection of the primary tumor.
Condition | Intervention | Phase |
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Rectal Neoplasms |
Procedure: endoscopic posterior mesorectal resection |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andreas Zerz, MD | +41 71 858 1428 | andreas.zerz@kssg.ch |
Switzerland | |
Department of Surgery | Recruiting |
St. Gallen, Switzerland, 9007 |
Principal Investigator: | Andreas Zerz, MD | Cantonal Hospital St. Gallen |
Study ID Numbers: | EKSG 05/072/2B |
Study First Received: | September 17, 2007 |
Last Updated: | September 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00531297 |
Health Authority: | Switzerland: Ethikkommission |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms Gastrointestinal Neoplasms Intestinal Diseases |
Rectal cancer Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms Rectal neoplasm |
Neoplasms Neoplasms by Site |