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

Not Applicable

Not yet recruiting

• Conditions: Rectal Neoplasms; Natural Orifice Specimen Extraction Surgery; Robotic Surgery
• Interventions: Procedure: Transanal specimen extraction robotic surgery; Procedure: Transabdominal specimen extraction robotic surgery

• Registration Number: NCT05468944
• Lead Sponsor: Taiyuan Li

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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-20
• Last Update Submitted: 2022-07-20
• Study First Posted: 2022-07-21
• Last Update Posted: 2022-07-21
• Study Start: 2023-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 556

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transanal group	Transanal specimen extraction robotic surgery	Participants in this group underwent robotic surgery with transanal specimen extraction
Transabdominal group	Transabdominal specimen extraction robotic surgery	Participants in this group underwent robotic surgery with transabdominal specimen extraction

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
Tumor-free survival rates	1, 3, 5 years postoperatively.	To assess the long-term postoperative outcomes.
LARS scale	1 day before operation, and 1, 3, 6 months postoperatively.	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.
EORTC QLQ-C30	1 day before operation, 1, 3, 6 months postoperatively.	To assess the quality of life of all cancer patients.
C-reactive protein (CRP)	1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.	Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.
Positive rate of tumor cells	Intraoperative.	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.
Tumor size	Up to 30 days postoperatively.	To assess the quality of surgical specimens.
Distance , positive condition of pathological margin (proximal, distal, circumferential)	Up to 30 days postoperatively.	To assess the quality of surgical specimens and postoperative pathological evaluation.
Overall survival rate	1, 3, 5 years postoperatively.	To assess the long-term postoperative outcomes.
Number of Histopathological type	Up to 30 days postoperatively.	To assess the quality of surgical specimens and postoperative pathological evaluation.
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 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).
EORTC QLQ-C38	1 day before operation, 1, 3, 6 months postoperatively.	To assess the quality of life in patients with rectal cancer.
Interleukin	1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.	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.
CD3, CD4, and CD8 lymphocyte subsets	1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.	Count CD3, CD4, and CD8 lymphocyte subsets (pieces/ul) to assess surgical stress response and immune function.
Degree of differentiation	Up to 30 days postoperatively.	To assess the quality of surgical specimens and postoperative pathological evaluation.
Hospitalization costs	Up to 30 days.	To assess the financial burden difference.
Cortisol	1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.	Detection of Serum Cortisol Level (nmol/L) to evaluate surgical stress response and immune function.
Pain assessment	1 day before operation, 1, 2, 3 days postoperatively, and up to 2 weeks.	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.
The incidence rate of distant metastasis	1, 3, 5 years postoperatively.	To assess the long-term postoperative outcomes.
bacterial positive rate	Intraoperative.	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.
Wexner scale	1 day before operation, and 1, 3, 6 months postoperatively.	Wexner scale (0 are normal continence, 20 are maximum incontinence with maximum disturbance of lifestyle) will be used to evaluate the defecation function.
Local recurrence rate	1, 3, 5 years postoperatively.	To assess the long-term postoperative outcomes.
Nerve vessel involvement rate	Up to 30 days postoperatively.	To assess the quality of surgical specimens and postoperative pathological evaluation.
Number of lymph node dissection and metastasis	Up to 30 days postoperatively.	To assess the quality of surgical specimens and postoperative pathological evaluation.

Trial Locations

Locations (12)

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

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

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

The Second Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, China

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

The Second Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, China

The First Affiliated Hospital of Gannan Medical University; 🇨🇳 Ganzhou, China

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

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China

Zhongshan Hospital of Xiamen University; 🇨🇳 Xiamen, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, China