The First Hospital of Jilin University
Changchun, Jilin, 130021, China
NCT Number: NCT06105203
This is a multicenter, superior, randomized controlled trial designed to compare Robotic-assisted total mesorectal excision (RATME) and laparoscopic-assisted total mesorectal excision (LATME) for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Changchun, Jilin, 130021, China
Robotic-assisted total mesorectal excision (RATME) has been gradually applied by colorectal surgeons. Most surgeons consider RATME a safe method and believe it can facilitate total mesorectal excision (TME) in rectal cancer, especially middle and low rectal cancer with a narrow pelvis. Therefore, this trial investigates whether RATME has technical advantages and increase intersphincteric resection rate compared with laparoscopic-assisted TME (LATME) in middle and low rectal cancer.
This is a multicenter, superior, randomized controlled trial designed to compare RATME and LATME for middle and low rectal cancer. The primary endpoint is the incidence of intersphincteric resection (ISR). The secondary outcomes are coloanal anastomosis (CAA), conversion to open, conversion to transanal TME (TaTME), incidence of abdominoperineal resection (APR), postoperative morbidity and mortality within 30 days after surgery, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life. In addition, certain measures will be conducted to ensure quality and safety, including centralized photography review and semiannual assessment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exit Criteria
TME will be performed with the assistance of robot in rectal cancer
TME will be performed with the assistance of laparoscopy in rectal cancer
Time frame: during the operation
The primary outcome is the incidence of ISR. ISR is defined according to the definition by a Japanese study group. When the distal resection margin is from dentate line to the intersphincteric groove, ISR will be recorded.The distal resection line of the internal anal sphincter was at the intersphincteric groove in total ISR, between the dentate line and the intersphincteric groove in subtotal ISR and at the dentate line in partial ISR
Time frame: during the operation
CAA was defined as the anastomosis of distal colon and surgical anal canal. In CAA anastomosis, the distal resection margin is below the upper level of the levator ani muscle. Conversion to open was defined as an abdominal incision larger than necessary for specimen retrieval.
Time frame: during the operation
Conversion to open surgery was defined as an abdominal incision larger than necessary for specimen retrieval extraction.
Time frame: during the operation
Conversion to TaTME was defined as TME that cannot be finished via transabdominal approach, and have to be finished by transanal approach with the help of imaging system and endoscopic instruments. It should be noted that if TME was completely done via transabdominal approach, simply dissecting the internal sphincter and intersphincteric space or finish the coloanal anastomosis via transanal approach were not classified as TaTME
Time frame: within 30 days after operation
The 30-day morbidity is defined as intraoperative adverse events and postoperative complications within 30 days. The intraoperative adverse events include intraoperative bleeding (>200 ml), pelvic vascular and nerve injury, vascular injury in other parts, digestive tract injury, ureteral injury, and anastomotic defect. Furthermore, the 30-day postoperative complications are evaluated according to Clavien-Dindo classification
Time frame: within 30 days after operation
The 30-day mortality is defined as death within 30 day after operation
Time frame: 3 years after operation
DFS is defined as the time from randomization to the discovery of local recurrence, distant metastasis, or death of the tumor
Time frame: 3 years after operation
LR is defined as tumor recurrence (evaluated by positron emission tomography, computed tomography, or magnetic resistance) that occurs in the pelvic cavity, perineal area, root of inferior mesenteric artery, descending colon, and sigmoid mesenteric area, and is confirmed through pathological biopsy or reoperation.
Time frame: 3 years after operation
OS is defined as the time from randomization to death due to any cause.
Time frame: within 30 days after operation
The distance to the DRM is defined as the shortest length between the tumor and the DRM. DRM positivity is defined as a distal margin within 1 mm of the tumor.
Time frame: within 30 days after operation
The distance to the CRM is defined as the shortest length between the tumor and the CRM. CRM positivity is defined as tumor cells within 1 mm from the CRM by microscopy
Time frame: 3 years after operation
Urinary function will be evaluated by International consultation on incontinence questionnaire short form (ICIQ-SF). The patients will be asked to complete ICIQ-SF every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.
Time frame: during the operation
the proportion of patients receiving abdominoperineal resection
Time frame: 3 years after operation
Quality of life will be evaluated by EORTC quality of life questionnaire-core 30 (QLQ-C30) form. The patients will be asked to complete QLQ-C30 every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.
Time frame: 3 years after operation
Sexual function of male will be evaluated by International Index of Erectile Function (IIEF-5). Sexual function of female will be evaluated by Female Sexual Function Index (FSFI). Evaluation will be performed every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.
Time frame: 3 years after operation
Defecation function will be evaluated by low anterior resection syndrome (LARS) form. The patients will be asked to complete LARS form every 3 months in the first year after operation, and every 6 months after the first year follow-up, until we finished the 3-year follow-up.
Contact information is provided by the study sponsor or research team.
The First Hospital of Jilin University
Other
A Multicenter Randomized Clinical Trial to Assess the Advantages of Robotic Total Mesorectal Excision in Preserving External Sphincter in Patients with Middle and Low Rectal Cancer.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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