Rectal Neoplasms Clinical Trial
Official title:
A Prospective Cohort Study of Transanal Laparoscopic Total Mesentery Excision Versus Conventional Laparoscopic Surgery for Rectal Cancer
NCT number | NCT02252250 |
Other study ID # | 20141056 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | November 2020 |
Verified date | November 2023 |
Source | Third Military Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.
Status | Completed |
Enrollment | 70 |
Est. completion date | November 2020 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Biopsy-proven adenocarcinoma of the rectum - Eligible to undergo conventional laparoscopic low anterior resection or transanal hybrid-laparoscopic low anterior resection with or without a temporary diverting stoma - Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI - Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic MRI - Rectal cancer located 3-10 cm from the anal verge Exclusion Criteria: - Metastasis - Obstructing rectal cancer - Synchronous colon cancer - T4 rectal cancer not treated preoperatively with full-course chemoradiation - Pregnant or breast-feeding - Receiving any other study agents - Fecal incontinence - History of prior colorectal cancer - History of inflammatory bowel disease - History of pelvic radiation - BMI > 40 - Large uterine fibroids - Uncontrolled intercurrent illness |
Country | Name | City | State |
---|---|---|---|
China | Daping hospital | Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
Third Military Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | defecating functional outcomes | constipation score and incontinence score | 1-6 years | |
Other | sexual functional outcomes | We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (International Index of Erectile Function (IIEF) | 1-6 years | |
Other | Quality of life outcomes evaluation | We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (Short Form-36 (SF36) and Gastro-Intestinal Functional Outcome(GIFO)) . | 1-6 years | |
Primary | Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens. | Lymph nodes number; rate of positive circumferential resection margin(CRM); | 1-6 years | |
Secondary | Incidence of 30-day perioperative complications including intraoperative, and postoperative complications | bleeding, injury of adjacent organs, ileus, leakage, infection | 0-30 days | |
Secondary | Incidence of long-term complications | incision hernia, | 1-6 years | |
Secondary | Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision. | overall survive rate and disease free survive rate of 3 and 5 years; recurrence rate | 1-6 years |
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