Natural Orifice Specimen Extraction Surgery, Rectal Cancer, Robotic Surgery
Conditions
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.
Interventions
PROCEDURER-NOSES group
robotic natural orifice specimen extraction surgery
PROCEDURER-TSES group
robotic transabdominal specimen extraction surgery
Sponsors
Taiyuan Li
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 86 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | Up to 30 days postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Intraoperative | — |
| Estimated blood loss | Intraoperative | — |
| Postoperative recovery composite | Up to 2 weeks | 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. |
| Postoperative hospital stay | Up to 4 weeks | From surgery to discharge |
| Postoperative white blood | 1, 3, 5 days postoperatively | Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function. |
| C-reactive protein (CRP) | 1, 3, 5 days postoperatively | Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function. |
| EORTC QLQ-C30 | Three months after surgery | 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. |
| BIQ | Three months after surgery | 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. |
| Pain assessment | 1, 3, 5 days postoperatively | 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. |
Countries
China
Outcome results
None listed