Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Early-Stage Rectal Cancer

Completed

• Conditions: Rectal Cancer; Robotic Surgery; Natural Orifice Specimen Extraction Surgery
• Interventions: Procedure: R-TSES group; Procedure: R-NOSES group

• Registration Number: NCT06405308
• Lead Sponsor: Taiyuan Li

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.

Study Timeline

• Study Start: 2023-10-01
• Primary Completion: 2024-01-15
• Study Completion: 2024-01-15
• Status Verified: 2024-05
• Study First Submitted: 2024-05-04
• Study First Submitted QC: 2024-05-04
• Study First Posted: 2024-05-08
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 636

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
R-TSES group	R-TSES group	Participants in this group underwent robotic transabdominal specimen extraction surgery
R-NOSES group	R-NOSES group	Participants in this group underwent robotic natural orifice specimen extraction surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Estimated blood loss	Intraoperative
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.
Operative time	Intraoperative
Postoperative hospital stay	Up to 4 weeks	From surgery to discharge
C-reactive protein (CRP)	1, 3, 5 days postoperatively	Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.
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 white blood	1, 3, 5 days postoperatively	Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.
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.

Trial Locations

Locations (8)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China

Three Gorges Hospital Affiliated to Chongqing University; 🇨🇳 Chongqing, 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

Fujian Cancer Hospital; 🇨🇳 Fuzhou, China