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

Rectal Cancer Clinical Trial

Official title:

Robotic Natural Orifice Specimen Extraction Surgery Versus Robotic Transabdominal Specimen Extraction Surgery for Rectal Cancer: a Multicentre Propensity Score-Matched Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06405308
• Other study ID #: NOSES-2024
• Status: Completed
• Start date: October 1, 2023
• Est. completion date: January 15, 2024

Study information

• Verified date: May 2024
• Source: The First Affiliated Hospital of Nanchang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 636
• Est. completion date: January 15, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 86 Years

Eligibility

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

Related Conditions & MeSH terms

• Natural Orifice Specimen Extraction Surgery
• Rectal Cancer
• Rectal Neoplasms
• Robotic Surgery

Intervention

Procedure:
• R-NOSES group
robotic natural orifice specimen extraction surgery
• R-TSES group
robotic transabdominal specimen extraction surgery

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
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

Sponsors (1)

Lead Sponsor	Collaborator
Taiyuan Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operative time		Intraoperative
Secondary	Estimated blood loss		Intraoperative
Secondary	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.	Up to 2 weeks
Secondary	Postoperative hospital stay	From surgery to discharge	Up to 4 weeks
Secondary	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.	1, 3, 5 days postoperatively
Secondary	C-reactive protein (CRP)	Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.	1, 3, 5 days postoperatively
Secondary	Postoperative white blood	Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.	1, 3, 5 days postoperatively
Secondary	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.	Three months after surgery
Secondary	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.	Three months after surgery