Natural Orifice Specimen Extraction Surgery for Colorectal Cancer (NOSE)
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ClinicalTrials.gov Identifier: NCT05740267 |
Recruitment Status :
Not yet recruiting
First Posted : February 23, 2023
Last Update Posted : February 23, 2023
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Tracking Information | |||||||||
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First Submitted Date ICMJE | January 30, 2023 | ||||||||
First Posted Date ICMJE | February 23, 2023 | ||||||||
Last Update Posted Date | February 23, 2023 | ||||||||
Estimated Study Start Date ICMJE | March 1, 2023 | ||||||||
Estimated Primary Completion Date | November 30, 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
C-reactive protein (CRP) level [ Time Frame: 3 minutes ] The primary outcome measure was the postoperative inflammatory response, which was evaluated by monitoring the C-reactive protein (CRP) level during hospitalization on the 3rd day following surgery. Complete blood cell count and differential count, C-reactive protein, procalcitonin, and interleukin-6 will be measured on day 3 postoperatively
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Natural Orifice Specimen Extraction Surgery for Colorectal Cancer | ||||||||
Official Title ICMJE | Natural Orifice Specimen Extraction Surgery for Colorectal Cancer (NOSE for CRC) | ||||||||
Brief Summary | The goal of this type of study: a prospective, randomized controlled clinical trial is to assess the safety and feasibility of NOSE surgery to compare the NOSE and conventional laparoscopy groups in Colorectal cancer patients. The main questions it aims to answer are measuring the postoperative inflammatory response and monitoring the early morbidity and mortality rate after surgery. Participants will be assigned patients to undergo either NOSE surgery or conventional laparoscopic mini-laparotomy resection. If there is a comparison group: Researchers will compare the control group to see if postoperative inflammatory response. | ||||||||
Detailed Description | Endpoints (Outcome measure): Primary endpoint: The primary outcome measure was the postoperative inflammatory response, which was evaluated by monitoring the C-reactive protein (CRP) level during hospitalization on the 3rd day following surgery. Early morbidity and mortality rate (postoperative 30 days): The early morbidity and mortality rate is defined as the event observed during the operation and within 30 days after surgery. Postoperative 30-day hospital readmission data will be also collected.
Long-term outcome: Overall survival Disease-free survival Cancer-specific survival Inclusion/Exclusion Criteria: Patient Enrollment Histological or cytological confirmation of colorectal adenocarcinoma. Inclusion criteria
(1) Not suitable for minimally invasive surgery (2) Body mass index (BMI) >30 kg/m2 (3) Malnutrition: albumin level less than 3.5 (4) Previous pelvic surgery (5) Emergency surgery Study Procedures: Randomization Randomization will be performed in the operating room at the Colorectal division, Linkou Chang Gung Memorial Hospital. Following the induction of minimally invasive surgery, an independent research assistant randomly assigned patients to undergo either NOSE surgery or conventional laparoscopic mini-laparotomy resection by sealed-envelope randomization. To ensure every group is similar in terms of covariates, especially the operation method (including right hemicolectomy, left hemicolectomy, and anterior resection). Randomization assignment is performed by the statisticians of the clinical trial center to generate random codes. Minimally invasive surgery Minimally invasive surgery will be performed in all operations, including multi-port laparoscopic surgery and robotic surgery. After the segment of bowel resection, the strategy for surgical specimen removal is according to the result of randomization. # Conventional laparoscopy group: The investigators can select either the intracorporeal or extracorporeal method to create bowel anastomoses. For the extracorporeal way, a mini-laparotomy wound is created and exteriorizes the bowel to do the anastomosis. The specimen is removed via the mini-laparotomy wound after the anastomosis is accomplished for the intracorporeal approach. # NOSE group: After bowel resection, all bowel anastomoses are created via side-to-side intracorporeal anastomosis, either isoperistaltic or antiperistaltic. The surgical steps of NOSE with the transrectal method are illustrated in Figure 1. First, the rectosigmoid colonic lumen is blocked with a bowel clamp. After rectal irrigation with povidone-iodine water, a transanal endoscopic microsurgery (TEM) scope or Alexis wound protector is inserted through the anus, reaching the upper rectum. Enterotomy is performed at the upper rectum, and a suction device is used to clean any fecal spillage. The TEM scope is pushed forward beyond the rectal opening, and the specimen is extracted with the TEM scope. The rectal opening is closed with a barbed suture, and an air leak test is performed to identify anastomotic leakage. Intra-operative evaluation Peritoneal lavage with 50 ml of normal saline on the Douglas pouch and the sub-phrenic area will be performed after the bowel anastomosis and before the abdominal wound closure. The estimated time would be 5 to 10 minutes. No additional risk will occur during the procedure. The investigators will do the peritoneal lavage fluid analysis in the following two phases:
Although minimally invasive surgery is performed with standard procedure, contamination is inconceivable to avoid. In the NOSE group, the rectum is opened and exposed to the peritoneal cavity, and bacterial contamination is inevitable. After finishing the anastomosis in each group, a microbiological sample is obtained from the peritoneal fluid specimens. The investigators will collect the data and analyze the correlation between NOSE and wound infection and intra-abdominal infection rates. Post-operative assessment The postoperative outcome will be analyzed as below:
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomization will be performed in the operating room at the Colorectal division, Linkou Chang Gung Memorial Hospital. Following the induction of minimally invasive surgery, an independent research assistant randomly assigned patients to undergo either NOSE surgery or conventional laparoscopic mini-laparotomy resection by sealed-envelope randomization. Masking: Single (Investigator)Masking Description: Randomization assignment is performed by the statisticians of the clinical trial center to generate random codes. Primary Purpose: Treatment
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Condition ICMJE | Colorectal Cancer | ||||||||
Intervention ICMJE | Procedure: Natural Orifice Specimen Extraction
After bowel resection, all bowel anastomoses are created via side-to-side intracorporeal anastomosis, either isoperistaltic or antiperistaltic. The surgical steps of NOSE with the transrectal method are illustrated in Figure 1. First, the rectosigmoid colonic lumen is blocked with a bowel clamp. After rectal irrigation with povidone-iodine water, a transanal endoscopic microsurgery (TEM) scope or Alexis wound protector is inserted through the anus, reaching the upper rectum. Enterotomy is performed at the upper rectum, and a suction device is used to clean any fecal spillage. The TEM scope is pushed forward beyond the rectal opening, and the specimen is extracted with the TEM scope. The rectal opening is closed with a barbed suture, and an air leak test is performed to identify anastomotic leakage.
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
318 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | November 30, 2025 | ||||||||
Estimated Primary Completion Date | November 30, 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Patient Enrollment Histological or cytological confirmation of colorectal adenocarcinoma. Inclusion criteria
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Not Provided | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05740267 | ||||||||
Other Study ID Numbers ICMJE | 202102468A3 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Chang Gung Memorial Hospital | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Chang Gung Memorial Hospital | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Chang Gung Memorial Hospital | ||||||||
Verification Date | December 2022 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |