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.
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.
Study Type
OBSERVATIONAL
Enrollment
636
robotic natural orifice specimen extraction surgery
robotic transabdominal specimen extraction surgery
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 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
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.
Time frame: Up to 30 days postoperatively
Operative time
Time frame: Intraoperative
Estimated blood loss
Time frame: Intraoperative
Postoperative recovery composite
Including the time to first flatus (record the patient's first self induced exhaust time after operation, accurate to hours) and time to first oral feeding.
Time frame: Up to 2 weeks
Postoperative hospital stay
From surgery to discharge
Time frame: Up to 4 weeks
Pain assessment
Visual analogue scale (VAS) will be used to evaluate the postoperative pain. If analgesics were needed, the type and dose of analgesics after operation should be recorded.
Time frame: 1, 3, 5 days postoperatively
C-reactive protein (CRP)
Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.
Time frame: 1, 3, 5 days postoperatively
Postoperative white blood
Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.
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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
Time frame: 1, 3, 5 days postoperatively
EORTC QLQ-C30
The EORTC QLQ-C30 includes functional score, symptom score, and Global Health Status. All project scores range from 0 to 100. The Functional score includes physical functioning, role functioning, emotion functioning, social functioning and cognitive functioning. The higher the functional score, the better the functional status of the patient. Symptom score includes nausea and vomiting, pain, dyspnoea, insomnia, loss of appetite, constipation, diarrhea, financial impact. A higher symptom score is associated with more severe symptoms and worse outcomes. The higher the Global Health Status, the better the health of the patient.
Time frame: Three months after surgery
BIQ
The BIQ is an eight-item questionnaire incorporating body image and cosmetic subscales, The body image scale measures patients' perception and satisfaction with their bodies after surgery. it ranges from 5 to 20 with a higher number representing greater body image perception. The cosmetic scale assesses satisfaction with surgical scars for a score range of 3-24, with a higher score indicating greater cosmetic satisfaction.
Time frame: Three months after surgery