Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial

Rectal Neoplasms Clinical Trial

Official title:

Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05468944
• Other study ID #: RO220624
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: December 2025

Study information

• Verified date: July 2022
• Source: The First Affiliated Hospital of Nanchang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective, multicenter, randomized, open-label study aims to evaluate the perioperative safety and feasibility of specimen extraction through anus regarding robotic radical excision of rectal cancer.

Description:

In this study, investigators will evaluate the perioperative safety and feasibility of robotic transanal specimen extraction surgery with robotic transabdominal incision specimen extraction surgery as a control.The study is prospective, randomized, open-label, and multicenter conducted at 12 centers. Considering the significance level and abscission rate, it is expected that a total of 556 subjects will be included in the two groups from January 2023 to June 2024, with the incidence of postoperative complications as the main study endpoint.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 556
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age between 18 to 75 years;

2. Historically confirmed rectal adenocarcinoma;

3. Diagnosed with rectal cancer by pelvic/rectal magnetic resonance imaging;

4. cT1-4aNxM0 high rectal adenocarcinoma; cT1-3NxM0 mid/low rectal adenocarcinoma;

5. No evidence of distant metastases;

6. A maximum of 5cm in diameter;

7. Body mass index (BMI) = 30 kg / m2;

8. No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, preoperatively abscess formation, no local invasion);

9. Willing to undergo surgery;

10. Sign the informed consent;

Exclusion Criteria:

1. Presence of lateral/inguinal lymph node metastases;

2. Previous history of malignant colorectal tumor;

3. Multiple primary colorectal tumors;

4. Neoadjuvant therapy;

5. Salvage surgery for endoscopic surgery;

6. History of previous abdominopelvic surgeries or extensive intra-abdominal adhesion;

7. Familial adenomatous polyposis, Lynch syndrome, and inflammatory bowel disease;

8. Comorbid with other malignancies within 5 years;

9. ASA = IV and/or ECOG performance status score = 2;

10. Severe liver, kidney, cardiopulmonary insufficiency, coagulopathy or serious underlying diseases;

11. Serious mental illness;

12. Pregnant or lactating women;

13. Uncontrolled infection;

14. Abnormal anal function or anal stenosis;

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Transanal specimen extraction robotic surgery
Participants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus.
• Transabdominal specimen extraction robotic surgery
Participants in this group underwent robotic assisted rectal cancer resection ,the specimens were extracted through the incision on the abdominal wall.

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing
China	The Second Xiangya Hospital, Central South University	Changsha
China	Three Gorges Hospital Affiliated to Chongqing University	Chongqing
China	Fujian Cancer Hospital	Fuzhou
China	The First Affiliated Hospital of Gannan Medical University	Ganzhou
China	The Second Affiliated Hospital, Sun Yat-sen University	Guangzhou
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 Xi'an Jiaotong University	Xi'an
China	Zhongshan Hospital of Xiamen University	Xiamen
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	C-reactive protein (CRP)	Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.	1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Secondary	Interleukin	Detection of serum levels of Interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10) (pg/L) to evaluate surgical stress response and immune function.	1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Secondary	Cortisol	Detection of Serum Cortisol Level (nmol/L) to evaluate surgical stress response and immune function.	1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Secondary	CD3, CD4, and CD8 lymphocyte subsets	Count CD3, CD4, and CD8 lymphocyte subsets (pieces/ul) to assess surgical stress response and immune function.	1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Secondary	Positive rate of tumor cells	Intraoperative peritoneal lavage fluid will be collected both for aerobic culture and centrifuged ,stained and viewed to find exfoliated cancer cells.The sample will be considered positive if at least one tumor cell was detected.	Intraoperative.
Secondary	bacterial positive rate	Intraoperative peritoneal lavage fluid will be collected both for aerobic culture and centrifuged ,stained and viewed to find exfoliated cancer cells.The sample will be considered positive if at least one tumor cell was detected.	Intraoperative.
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 day before operation, 1, 2, 3 days postoperatively, and up to 2 weeks.
Secondary	Wexner scale	Wexner scale (0 are normal continence, 20 are maximum incontinence with maximum disturbance of lifestyle) will be used to evaluate the defecation function.	1 day before operation, and 1, 3, 6 months postoperatively.
Secondary	LARS scale	LARS scale(0~20 points are defined as no LARS, Scores from 21 to 29 were defined as mild LARS, and from 30 to 42 as severe LARS. The higher the score, the worse the anal bowel function) will be used to evaluate the defecation function.	1 day before operation, and 1, 3, 6 months postoperatively.
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 perform auscultation of bowel sounds regularly every day after operation), the time to first ambulation (hours), the time to first eating (hours) and the time to first defecation (hours).	Up to 2 weeks.
Secondary	EORTC QLQ-C30	To assess the quality of life of all cancer patients.	1 day before operation, 1, 3, 6 months postoperatively.
Secondary	EORTC QLQ-C38	To assess the quality of life in patients with rectal cancer.	1 day before operation, 1, 3, 6 months postoperatively.
Secondary	Tumor size	To assess the quality of surgical specimens.	Up to 30 days postoperatively.
Secondary	Number of Histopathological type	To assess the quality of surgical specimens and postoperative pathological evaluation.	Up to 30 days postoperatively.
Secondary	Degree of differentiation	To assess the quality of surgical specimens and postoperative pathological evaluation.	Up to 30 days postoperatively.
Secondary	Distance , positive condition of pathological margin (proximal, distal, circumferential)	To assess the quality of surgical specimens and postoperative pathological evaluation.	Up to 30 days postoperatively.
Secondary	Number of lymph node dissection and metastasis	To assess the quality of surgical specimens and postoperative pathological evaluation.	Up to 30 days postoperatively.
Secondary	Nerve vessel involvement rate	To assess the quality of surgical specimens and postoperative pathological evaluation.	Up to 30 days postoperatively.
Secondary	Hospitalization costs	To assess the financial burden difference.	Up to 30 days.
Secondary	Local recurrence rate	To assess the long-term postoperative outcomes.	1, 3, 5 years postoperatively.
Secondary	The incidence rate of distant metastasis	To assess the long-term postoperative outcomes.	1, 3, 5 years postoperatively.
Secondary	Tumor-free survival rates	To assess the long-term postoperative outcomes.	1, 3, 5 years postoperatively.
Secondary	Overall survival rate	To assess the long-term postoperative outcomes.	1, 3, 5 years postoperatively.