Clinical trial NCT06405308: Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Early-Stage Rectal Cancer
Official title: Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Rectal Cancer: a Multicentre Propensity Score-Matched Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Robotic Surgery
Natural Orifice Specimen Extraction Surgery
Lead sponsor: The First Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 636
Sex: ALL
Minimum age (years): 20
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent R-NOSES or R-TSES for early-stage rectal cancer between October 2015 and November 2023.

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.

Detailed description: In this retrospective cohort study, data from 1086 patients who underwent R-NOSES or R-TSES for early-stage rectal cancer between October 2015 and November 2023 were collected from a prospectively maintained database of 8 experienced surgeons from 8 high-volume centers in china. The study was aimed to compare the surgical quality and short-term outcomes of R-NOSES with R-TSES for early-stage rectal cancer.

Eligibility criteria: Inclusion Criteria:

1. histologically confirmed rectal adenocarcinoma
2. robotic TME for rectal adenocarcinoma
3. postoperative pathological staging of T1-2N0M0
4. complete surgical and postoperative follow-up information

Exclusion Criteria:

1. body mass index (BMI) ≥ 35 kg/m2
2. history of abdominal surgery
3. history of pelvic surgery
4. presence of another primary cancer
5. previous endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR)
6. anal or vaginal disease
7. ileostomy or transverse colostomy
8. conversion to open operation
9. tumor distant metastasis

Primary outcomes:
measure: Complication rate
timeFrame: Up to 30 days postoperatively
Secondary outcomes:
measure: Operative time
timeFrame: Intraoperative
measure: Estimated blood loss
timeFrame: Intraoperative
measure: Postoperative recovery composite
timeFrame: Up to 2 weeks
measure: Postoperative hospital stay
timeFrame: Up to 4 weeks
measure: Pain assessment
timeFrame: 1, 3, 5 days postoperatively
measure: C-reactive protein (CRP)
timeFrame: 1, 3, 5 days postoperatively
measure: Postoperative white blood
timeFrame: 1, 3, 5 days postoperatively
measure: EORTC QLQ-C30
timeFrame: Three months after surgery
measure: BIQ
timeFrame: Three months after surgery
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
city: Chongqing
country: China
facility: Three Gorges Hospital Affiliated to Chongqing University
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
References: