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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

Primary Purpose

Rectal Neoplasms, Robotic Surgery, Natural Orifice Specimen Extraction Surgery

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transanal specimen extraction robotic surgery
Transabdominal specimen extraction robotic surgery
Sponsored by
Taiyuan Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • The Second Xiangya Hospital, Central South University
  • Three Gorges Hospital Affiliated to Chongqing University
  • Fujian Cancer Hospital
  • The First Affiliated Hospital of Gannan Medical University
  • The Second Affiliated Hospital, Sun Yat-sen University
  • The Second Affiliated Hospital of Harbin Medical University
  • The First Affiliated Hospital of Nanchang University
  • Zhongshan Hospital, Fudan University
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • Zhongshan Hospital of Xiamen University
  • The First Affiliated Hospital of Zhengzhou University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transanal group

Transabdominal group

Arm Description

Participants in this group underwent robotic surgery with transanal specimen extraction

Participants in this group underwent robotic surgery with transabdominal specimen extraction

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

C-reactive protein (CRP)
Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.
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.
Cortisol
Detection of Serum Cortisol Level (nmol/L) to evaluate surgical stress response and immune function.
CD3, CD4, and CD8 lymphocyte subsets
Count CD3, CD4, and CD8 lymphocyte subsets (pieces/ul) to assess surgical stress response and immune function.
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.
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.
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.
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.
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.
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).
EORTC QLQ-C30
To assess the quality of life of all cancer patients.
EORTC QLQ-C38
To assess the quality of life in patients with rectal cancer.
Tumor size
To assess the quality of surgical specimens.
Number of Histopathological type
To assess the quality of surgical specimens and postoperative pathological evaluation.
Degree of differentiation
To assess the quality of surgical specimens and postoperative pathological evaluation.
Distance , positive condition of pathological margin (proximal, distal, circumferential)
To assess the quality of surgical specimens and postoperative pathological evaluation.
Number of lymph node dissection and metastasis
To assess the quality of surgical specimens and postoperative pathological evaluation.
Nerve vessel involvement rate
To assess the quality of surgical specimens and postoperative pathological evaluation.
Hospitalization costs
To assess the financial burden difference.
Local recurrence rate
To assess the long-term postoperative outcomes.
The incidence rate of distant metastasis
To assess the long-term postoperative outcomes.
Tumor-free survival rates
To assess the long-term postoperative outcomes.
Overall survival rate
To assess the long-term postoperative outcomes.

Full Information

First Posted
July 13, 2022
Last Updated
July 20, 2022
Sponsor
Taiyuan Li
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1. Study Identification

Unique Protocol Identification Number
NCT05468944
Brief Title
Robotic Transanal Specimen Extraction Surgery Versus Robotic Transabdominal Incision Specimen Extraction Surgery for Patients With Rectal Cancer: A Multicenter Randomized Controlled 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Taiyuan Li

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms, Robotic Surgery, Natural Orifice Specimen Extraction Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
556 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transanal group
Arm Type
Experimental
Arm Description
Participants in this group underwent robotic surgery with transanal specimen extraction
Arm Title
Transabdominal group
Arm Type
Active Comparator
Arm Description
Participants in this group underwent robotic surgery with transabdominal specimen extraction
Intervention Type
Procedure
Intervention Name(s)
Transanal specimen extraction robotic surgery
Intervention Description
Participants in this group underwent robotic rectal cancer resection ,the specimens were extracted through anus.
Intervention Type
Procedure
Intervention Name(s)
Transabdominal specimen extraction robotic surgery
Intervention Description
Participants in this group underwent robotic assisted rectal cancer resection ,the specimens were extracted through the incision on the abdominal wall.
Primary Outcome Measure Information:
Title
Complication rate
Description
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.
Time Frame
Up to 30 days postoperatively.
Secondary Outcome Measure Information:
Title
C-reactive protein (CRP)
Description
Detection of serum CRP levels (mg/L) to evaluate surgical stress response and immune function.
Time Frame
1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Title
Interleukin
Description
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.
Time Frame
1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Title
Cortisol
Description
Detection of Serum Cortisol Level (nmol/L) to evaluate surgical stress response and immune function.
Time Frame
1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Title
CD3, CD4, and CD8 lymphocyte subsets
Description
Count CD3, CD4, and CD8 lymphocyte subsets (pieces/ul) to assess surgical stress response and immune function.
Time Frame
1 day before operation, 1, 3, 5 days postoperatively, and up to 2 weeks.
Title
Positive rate of tumor cells
Description
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.
Time Frame
Intraoperative.
Title
bacterial positive rate
Description
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.
Time Frame
Intraoperative.
Title
Pain assessment
Description
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.
Time Frame
1 day before operation, 1, 2, 3 days postoperatively, and up to 2 weeks.
Title
Wexner scale
Description
Wexner scale (0 are normal continence, 20 are maximum incontinence with maximum disturbance of lifestyle) will be used to evaluate the defecation function.
Time Frame
1 day before operation, and 1, 3, 6 months postoperatively.
Title
LARS scale
Description
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.
Time Frame
1 day before operation, and 1, 3, 6 months postoperatively.
Title
Postoperative recovery composite
Description
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).
Time Frame
Up to 2 weeks.
Title
EORTC QLQ-C30
Description
To assess the quality of life of all cancer patients.
Time Frame
1 day before operation, 1, 3, 6 months postoperatively.
Title
EORTC QLQ-C38
Description
To assess the quality of life in patients with rectal cancer.
Time Frame
1 day before operation, 1, 3, 6 months postoperatively.
Title
Tumor size
Description
To assess the quality of surgical specimens.
Time Frame
Up to 30 days postoperatively.
Title
Number of Histopathological type
Description
To assess the quality of surgical specimens and postoperative pathological evaluation.
Time Frame
Up to 30 days postoperatively.
Title
Degree of differentiation
Description
To assess the quality of surgical specimens and postoperative pathological evaluation.
Time Frame
Up to 30 days postoperatively.
Title
Distance , positive condition of pathological margin (proximal, distal, circumferential)
Description
To assess the quality of surgical specimens and postoperative pathological evaluation.
Time Frame
Up to 30 days postoperatively.
Title
Number of lymph node dissection and metastasis
Description
To assess the quality of surgical specimens and postoperative pathological evaluation.
Time Frame
Up to 30 days postoperatively.
Title
Nerve vessel involvement rate
Description
To assess the quality of surgical specimens and postoperative pathological evaluation.
Time Frame
Up to 30 days postoperatively.
Title
Hospitalization costs
Description
To assess the financial burden difference.
Time Frame
Up to 30 days.
Title
Local recurrence rate
Description
To assess the long-term postoperative outcomes.
Time Frame
1, 3, 5 years postoperatively.
Title
The incidence rate of distant metastasis
Description
To assess the long-term postoperative outcomes.
Time Frame
1, 3, 5 years postoperatively.
Title
Tumor-free survival rates
Description
To assess the long-term postoperative outcomes.
Time Frame
1, 3, 5 years postoperatively.
Title
Overall survival rate
Description
To assess the long-term postoperative outcomes.
Time Frame
1, 3, 5 years postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 to 75 years; Historically confirmed rectal adenocarcinoma; Diagnosed with rectal cancer by pelvic/rectal magnetic resonance imaging; cT1-4aNxM0 high rectal adenocarcinoma; cT1-3NxM0 mid/low rectal adenocarcinoma; No evidence of distant metastases; A maximum of 5cm in diameter; Body mass index (BMI) ≤ 30 kg / m2; No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no perforation, preoperatively abscess formation, no local invasion); Willing to undergo surgery; Sign the informed consent; Exclusion Criteria: Presence of lateral/inguinal lymph node metastases; Previous history of malignant colorectal tumor; Multiple primary colorectal tumors; Neoadjuvant therapy; Salvage surgery for endoscopic surgery; History of previous abdominopelvic surgeries or extensive intra-abdominal adhesion; Familial adenomatous polyposis, Lynch syndrome, and inflammatory bowel disease; Comorbid with other malignancies within 5 years; ASA ≥ IV and/or ECOG performance status score ≥ 2; Severe liver, kidney, cardiopulmonary insufficiency, coagulopathy or serious underlying diseases; Serious mental illness; Pregnant or lactating women; Uncontrolled infection; Abnormal anal function or anal stenosis;
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xishan Wang
Facility Name
The Second Xiangya Hospital, Central South University
City
Changsha
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongliang Yao
Facility Name
Three Gorges Hospital Affiliated to Chongqing University
City
Chongqing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dehai Xiong
Facility Name
Fujian Cancer Hospital
City
Fuzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunkang Yang
Facility Name
The First Affiliated Hospital of Gannan Medical University
City
Ganzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangfu Zeng
Facility Name
The Second Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fanghai Han
Facility Name
The Second Affiliated Hospital of Harbin Medical University
City
Harbin
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guiyu Wang
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taiyuan Li
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Wei
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junjun She
Facility Name
Zhongshan Hospital of Xiamen University
City
Xiamen
ZIP/Postal Code
361004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianchun Cai
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junhong Hu

12. IPD Sharing Statement

Learn more about this trial

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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