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

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ClinicalTrials.gov Identifier: NCT05468944
Recruitment Status : Not yet recruiting
First Posted : July 21, 2022
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
Taiyuan Li, The First Affiliated Hospital of Nanchang University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rectal Neoplasms Robotic Surgery Natural Orifice Specimen Extraction Surgery Procedure: Transanal specimen extraction robotic surgery Procedure: Transabdominal specimen extraction robotic surgery Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 556 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Transanal group
Participants in this group underwent robotic surgery with transanal specimen extraction
 Procedure: Transanal specimen extraction robotic surgery
Participants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus.
Active Comparator: Transabdominal group
Participants in this group underwent robotic surgery with transabdominal specimen extraction
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Complication rate [ Time Frame: 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 :
  1. C-reactive protein (CRP) [ Time Frame: 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.

  2. Interleukin [ Time Frame: 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.

  3. Cortisol [ Time Frame: 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.

  4. CD3, CD4, and CD8 lymphocyte subsets [ Time Frame: 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.

  5. Positive rate of tumor cells [ Time Frame: 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.

  6. bacterial positive rate [ Time Frame: 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.

  7. Pain assessment [ Time Frame: 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.

  8. Wexner scale [ Time Frame: 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.

  9. LARS scale [ Time Frame: 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.

  10. Postoperative recovery composite [ Time Frame: 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).

  11. EORTC QLQ-C30 [ Time Frame: 1 day before operation, 1, 3, 6 months postoperatively. ]
    To assess the quality of life of all cancer patients.

  12. EORTC QLQ-C38 [ Time Frame: 1 day before operation, 1, 3, 6 months postoperatively. ]
    To assess the quality of life in patients with rectal cancer.

  13. Tumor size [ Time Frame: Up to 30 days postoperatively. ]
    To assess the quality of surgical specimens.

  14. Number of Histopathological type [ Time Frame: Up to 30 days postoperatively. ]
    To assess the quality of surgical specimens and postoperative pathological evaluation.

  15. Degree of differentiation [ Time Frame: Up to 30 days postoperatively. ]
    To assess the quality of surgical specimens and postoperative pathological evaluation.

  16. Distance , positive condition of pathological margin (proximal, distal, circumferential) [ Time Frame: Up to 30 days postoperatively. ]
    To assess the quality of surgical specimens and postoperative pathological evaluation.

  17. Number of lymph node dissection and metastasis [ Time Frame: Up to 30 days postoperatively. ]
    To assess the quality of surgical specimens and postoperative pathological evaluation.

  18. Nerve vessel involvement rate [ Time Frame: Up to 30 days postoperatively. ]
    To assess the quality of surgical specimens and postoperative pathological evaluation.

  19. Hospitalization costs [ Time Frame: Up to 30 days. ]
    To assess the financial burden difference.

  20. Local recurrence rate [ Time Frame: 1, 3, 5 years postoperatively. ]
    To assess the long-term postoperative outcomes.

  21. The incidence rate of distant metastasis [ Time Frame: 1, 3, 5 years postoperatively. ]
    To assess the long-term postoperative outcomes.

  22. Tumor-free survival rates [ Time Frame: 1, 3, 5 years postoperatively. ]
    To assess the long-term postoperative outcomes.

  23. Overall survival rate [ Time Frame: 1, 3, 5 years postoperatively. ]
    To assess the long-term postoperative outcomes.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05468944


Locations
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China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Contact: Xishan Wang         
The Second Xiangya Hospital, Central South University
Changsha, China
Contact: Hongliang Yao         
Three Gorges Hospital Affiliated to Chongqing University
Chongqing, China
Contact: Dehai Xiong         
Fujian Cancer Hospital
Fuzhou, China
Contact: Chunkang Yang         
The First Affiliated Hospital of Gannan Medical University
Ganzhou, China
Contact: Xiangfu Zeng         
The Second Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
Contact: Fanghai Han         
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
Contact: Guiyu Wang         
The First Affiliated Hospital of Nanchang University
Nanchang, China
Contact: Taiyuan Li         
Zhongshan Hospital, Fudan University
Shanghai, China
Contact: Ye Wei         
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Contact: Junjun She         
Zhongshan Hospital of Xiamen University
Xiamen, China, 361004
Contact: Jianchun Cai         
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Contact: Junhong Hu         
Sponsors and Collaborators
Taiyuan Li
More Information
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Responsible Party: Taiyuan Li, Professor, The First Affiliated Hospital of Nanchang University
ClinicalTrials.gov Identifier: NCT05468944    
Other Study ID Numbers: RO220624
First Posted: July 21, 2022    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases