Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Early-Stage Rectal Cancer
1 other identifier
observational
636
1 country
8
Brief Summary
A retrospective cohort study, conducted nationwide（China） and across multiple centers, aimed to compare the surgical quality and short-term outcomes of R-NOSES （robotic natural orifice specimen extraction surgery）with R-TSES （robotic transabdominal specimen extraction surgery） for early-stage rectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Shorter than P25 for all trials
8 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
Study Start
First participant enrolled
October 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2024
CompletedFirst Submitted
Initial submission to the registry
May 4, 2024
CompletedFirst Posted
Study publicly available on registry
May 8, 2024
CompletedMay 13, 2024
May 1, 2024
4 months
May 4, 2024
May 9, 2024
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 (9)
Operative time
Intraoperative
Estimated blood loss
Intraoperative
Postoperative recovery composite
Up to 2 weeks
Postoperative hospital stay
Up to 4 weeks
Pain assessment
1, 3, 5 days postoperatively
- +4 more secondary outcomes
Study Arms (2)
R-NOSES group
Participants in this group underwent robotic natural orifice specimen extraction surgery
R-TSES group
Participants in this group underwent robotic transabdominal specimen extraction surgery
Interventions
Eligibility Criteria
Patients who underwent R-NOSES or R-TSES for early-stage rectal cancer between October 2015 and November 2023.
You may qualify if:
- histologically confirmed rectal adenocarcinoma
- robotic TME for rectal adenocarcinoma
- postoperative pathological staging of T1-2N0M0
- complete surgical and postoperative follow-up information
You may not qualify if:
- body mass index (BMI) ≥ 35 kg/m2
- history of abdominal surgery
- history of pelvic surgery
- presence of another primary cancer
- previous endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR)
- anal or vaginal disease
- ileostomy or transverse colostomy
- conversion to open operation
- tumor distant metastasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taiyuan Lilead
Study Sites (8)
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Three Gorges Hospital Affiliated to Chongqing University
Chongqing, China
Fujian Cancer Hospital
Fuzhou, 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 Zhengzhou University
Zhengzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 4, 2024
First Posted
May 8, 2024
Study Start
October 1, 2023
Primary Completion
January 15, 2024
Study Completion
January 15, 2024
Last Updated
May 13, 2024
Record last verified: 2024-05