Rectal Cancer Patients, Robotic Surgical Procedures
Conditions
Brief summary
Single-port versus multi-port robotic surgery for rectal cancer
Detailed description
This study is a stage 2 clinical trial based on the IDEAL framework, which aims to evaluate the safety and short-term clinical efficacy of single-port robotic total mesorectal excision by comparing it with multi-port robotic total mesorectal excision. The primary endpoint is short-term clinical efficacy, including intraoperative complications, blood loss, conversion rate, operation time, postoperative complications within 30 days, time to first flatus after surgery, and postoperative hospital stay. Secondary endpoints include incision length, visual analog scale (VAS) scores for postoperative pain on days 1-3, completeness of mesorectal excision grading, positive circumferential resection margin rate, positive distal resection margin rate, and the number of harvested lymph nodes. This study was conducted in two phases: Phase I (Stage 2a): A single-arm study of single-port robotic radical resection for rectal cancer (n=20) Phase II (Stage 2b): A prospective non-randomized controlled study comparing single-port (n=100) versus multi-port (n=100) robotic radical resection for rectal cancer
Interventions
PROCEDURESingle-port robotic total mesorectal excision
Single-port robotic total mesorectal excision
PROCEDUREMulti-port robotic total mesorectal excision
Multi-port robotic total mesorectal excision
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
comprised: (1) MRI-confirmed distal tumor margin \<15 cm from the anal verge, (2) biopsy-proven adenocarcinoma, (3) clinical stage I-III (AJCC 8th edition) with potential downstaging post-neoadjuvant therapy, (4) intent-to-treat with sphincter preservation and primary anastomosis, (5) documented informed consent, and (6) adult patients (≥18 years).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of perioperative complications | Intraoperative and postoperative 30 days | Perioperative complications will be described using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v. 4.03 criteria. Complications will refer to any medical occurrence directly attributed to the surgical procedure during and within the first 30 days. |
| Number of participants with conversion procedures | Date of surgery (Day 1) | The number of patients converted from robotic to open or laparoscopic surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | Postoperative days 1-3 | Visual Analog Scale (VAS) pain scores for patients on postoperative days 1-3 |
| Quality of specimen | Date of surgery (Day 1) | As proposed and published by Quirke et al（Macroscopic evaluation of rectal cancer resection specimen: clinical significance of the pathologist in quality control. J Clin Oncol. 2002 Apr 1;20(7):1729-34.） |
| Total length of incisions | Date of surgery (Day 1) | Total length of all abdominal incisions (measured in millimeters). |
Countries
China
Contacts
CONTACTHuichao Zheng, MD
STUDY_DIRECTORFan Li
Army Medical Center (Daping Hospital), Army Medical University
Outcome results
None listed