Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial
1 other identifier
interventional
556
1 country
12
Brief Summary
This prospective, multicenter, randomized, open-label study aims to evaluate the perioperative safety and feasibility of specimen extraction through anus regarding robotic radical excision of rectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
Typical duration for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2022
CompletedFirst Posted
Study publicly available on registry
July 21, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJuly 21, 2022
July 1, 2022
2.9 years
July 13, 2022
July 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Complication rate
Complication rate within 1 month postoperatively.All complications of surgery will be documented and graded by the Clavien-Dindo classification system,generally including anastomotic leakage, abdominal infection, bleeding, incision infection, incision implantation, intestinal obstruction, and rectovaginal fistula.
Up to 30 days postoperatively.
Secondary Outcomes (23)
C-reactive protein (CRP)
1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Interleukin
1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Cortisol
1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
CD3, CD4, and CD8 lymphocyte subsets
1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Positive rate of tumor cells
Intraoperative.
- +18 more secondary outcomes
Study Arms (2)
Transanal group
EXPERIMENTALParticipants in this group underwent robotic surgery with transanal specimen extraction
Transabdominal group
ACTIVE COMPARATORParticipants in this group underwent robotic surgery with transabdominal specimen extraction
Interventions
Participants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus.
Participants in this group underwent robotic assisted rectal cancer resection ,the specimens were extracted through the incision on the abdominal wall.
Eligibility Criteria
You may qualify if:
- Age between 18 to 75 years;
- Historically confirmed rectal adenocarcinoma;
- Diagnosed with rectal cancer by pelvic/rectal magnetic resonance imaging;
- cT1-4aNxM0 high rectal adenocarcinoma; cT1-3NxM0 mid/low rectal adenocarcinoma;
- No evidence of distant metastases;
- A maximum of 5cm in diameter;
- Body mass index (BMI) ≤ 30 kg / m2;
- No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, preoperatively abscess formation, no local invasion);
- Willing to undergo surgery;
- Sign the informed consent;
You may not qualify if:
- Presence of lateral/inguinal lymph node metastases;
- Previous history of malignant colorectal tumor;
- Multiple primary colorectal tumors;
- Neoadjuvant therapy;
- Salvage surgery for endoscopic surgery;
- History of previous abdominopelvic surgeries or extensive intra-abdominal adhesion;
- Familial adenomatous polyposis, Lynch syndrome, and inflammatory bowel disease;
- Comorbid with other malignancies within 5 years;
- ASA ≥ IV and/or ECOG performance status score ≥ 2;
- Severe liver, kidney, cardiopulmonary insufficiency, coagulopathy or serious underlying diseases;
- Serious mental illness;
- Pregnant or lactating women;
- Uncontrolled infection;
- Abnormal anal function or anal stenosis;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taiyuan Lilead
Study Sites (12)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
The Second Xiangya Hospital, Central South University
Changsha, China
Three Gorges Hospital Affiliated to Chongqing University
Chongqing, China
Fujian Cancer Hospital
Fuzhou, China
The First Affiliated Hospital of Gannan Medical University
Ganzhou, China
The Second Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Zhongshan Hospital, Fudan University
Shanghai, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Zhongshan Hospital of Xiamen University
Xiamen, 361004, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 13, 2022
First Posted
July 21, 2022
Study Start
January 1, 2023
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
July 21, 2022
Record last verified: 2022-07