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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
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Natural Orifice Specimen Extraction Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
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
Official Title: Natural Orifice Specimen Extraction Surgery for Colorectal Cancer (NOSE for CRC)
Estimated Study Start Date : March 1, 2023
Estimated Primary Completion Date : November 30, 2025
Estimated Study Completion Date : November 30, 2025
Arms and Interventions
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Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Duration of Operation time [ Time Frame: 60~90 minutes ]
    The length of the surgery will be recorded.

  2. Peritoneal Cytology during surgery [ Time Frame: 3 minutes ]
    The investigators assess the tumor cells identified by peritoneal cytologic specimens. Given the relationship of positive cytology with metachronous peritoneal seeding, it is essential to evaluate datasets from participants who undergo the NOSE group. The investigators will compare the positive rate of peritoneal cytology in the two groups.

  3. Peritoneal Contamination during surgery [ Time Frame: 3 minutes ]
    Peritoneal fluid samples were collected under sterile circumstances at the end of the surgery and sent for aerobic and anaerobic cultures. The investigators evaluate the contamination rate of peritoneal fluid in the two groups. 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.

  4. Postoperative Pain Score [ Time Frame: 3 minutes ]
    Pain intensity is assessed using a Numeric Rating Scale (NRS) with scores from 0 to 10 (10 = the worst pain). The highest pain scores of patients on each day for three consecutive days postoperatively will be recorded for further evaluation.

  5. Postoperative Recovery course: [ Time Frame: 1 to 5 days ]
    Time to first flatus passage Time to first liquid diet Time to first soft diet The length of hospital stays


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient Enrollment Histological or cytological confirmation of colorectal adenocarcinoma. Inclusion criteria

  1. Age ≥ 18
  2. Performance status of 0 - 2 on the ECOG (Eastern Cooperative Oncology Group) scale
  3. American Society of Anesthesiology (ASA) score is Ⅰ-Ⅲ
  4. Tumor location: CRC with the lower margin of the tumor greater than 10 cm from the anal verge
  5. Pre-operative T staging: T0-T4a at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
  6. Preoperative M staging: M0 according to AJCC 8th
  7. Tumor size: 4 cm or less
  8. Written informed consent for participation

Exclusion 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
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): NCT05740267


Contacts
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Contact: Jeng-Fu You +886-3-3281200 ext 2101 jenodyssey@gmail.com
Contact: Yih-Jong Chern +886-3-3281200 ext 2101 ufo789.ufo789@gmail.com

Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Director: Jeng-Fu You Principal Investigator
More Information
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Additional Information:

Publications:

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT05740267    
Other Study ID Numbers: 202102468A3
First Posted: February 23, 2023    Key Record Dates
Last Update Posted: February 23, 2023
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases