Rectal Neoplasms Clinical Trial
Official title:
Endoscopic Submucosal Dissection (ESD) Versus Transanal Minimally Invasive Surgery (TAMIS) for Early Rectal Neoplasms: a Prospective Randomized Controlled Trial
This is a prospective randomized controlled trial that aimed to compare the short-term clinical outcomes, functional outcomes, costs, and recurrence rates between endoscopic submucosal dissection (ESD) and transanal minimally invasive surgery (TAMIS) for early rectal neoplasms.
Status | Recruiting |
Enrollment | 114 |
Est. completion date | July 2020 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients diagnosed with nonpedunculated early rectal neoplasms >/= 2 cm in size in the rectum (>/= 3 cm and </= 18 cm from the anal verge) that are deemed not feasible for en bloc resection with conventional polypectomy or EMR as judged by two experienced endoscopist - Age of patients >18 years; - American Society of Anesthesiologists (ASA) grading I-III - Informed consent available Exclusion Criteria: - Presence of endoscopic signs of massive submucosal invasion (including excavated/depressed morphology, Kudo's pit pattern Type V, or Sano's capillary pattern Type IIIB) - Evidence of deep invasion on endorectal ultrasonography - Unfavorable histopathologic features on biopsy (mucinous cancer, poor differentiation, or gross submucosal invasion) - Patients with other synchronous colorectal neoplasms in addition to the index neoplasm that are indicated for surgical resection - Patients with recurrence from previous Endoscopic Mucosal Resection or ESD - Patients with known metastatic disease - Patients with non-correctable coagulopathy |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Short-term morbidity | Short-term morbidity/mortality within 30 days after the procedure (including intraprocedural morbidity/mortality), defined by the Clavien-Dindo classification of surgical complications | Up to 1 month | |
Secondary | En bloc resection rate | Resection with a single piece | Up to 1 month | |
Secondary | R0 resection rate | Complete resection of the neoplasm with clear lateral and deep margins at histology | Up to 1 month | |
Secondary | Time to resume normal diet | Up to 1 month | ||
Secondary | Time to walk independently | Up to 1 month | ||
Secondary | Length of hospital stay | Up to 1 month | ||
Secondary | Anal continence | Measured by the Wexner's score | Up to 1 year | |
Secondary | Fecal incontinence quality of life (FIQL) | Measured by the FIQL questionnaire | Up to 1 year | |
Secondary | Quality of life measured by the Short Form-36 (SF-36) Health Survey questionnaire | SF-36 Health Survey is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | Up to 1 year | |
Secondary | Direct medical costs | Up to 1 year | ||
Secondary | Local recurrence | Up to 3 years |
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