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

NCT ID: NCT05468944

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 556 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Rectal Neoplasms; Robotic Surgery; Natural Orifice Specimen Extraction Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transanal group

Participants in this group underwent robotic surgery with transanal specimen extraction

Group Type: EXPERIMENTAL

Transanal specimen extraction robotic surgery

Intervention Type: PROCEDURE

Participants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus.

Transabdominal group

Participants in this group underwent robotic surgery with transabdominal specimen extraction

Group Type: ACTIVE_COMPARATOR

Transabdominal specimen extraction robotic surgery

Intervention Type: PROCEDURE

Participants in this group underwent robotic assisted rectal cancer resection ,the specimens were extracted through the incision on the abdominal wall.

Interventions

Transanal specimen extraction robotic surgery

Participants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiyuan Li

OTHER

Sponsor Role: lead

Responsible Party

Taiyuan Li

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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, , China

Countries

China

Facility Contacts

Xishan Wang

Role: primary

Hongliang Yao

Role: primary

Dehai Xiong

Role: primary

Chunkang Yang

Role: primary

Xiangfu Zeng

Role: primary

Fanghai Han

Role: primary

Guiyu Wang

Role: primary

Taiyuan Li

Role: primary

Ye Wei

Role: primary

Junjun She

Role: primary

Jianchun Cai

Role: primary

Junhong Hu

Role: primary

Other Identifiers

RO220624

Identifier Type: -

Identifier Source: org_study_id