- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04559087
Comparison of NOSES and Conventional Laparoscopic Surgery in Colorectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fujian Xu, Master
- Phone Number: +8615895864837
- Email: 911583440@qq.com
Study Contact Backup
- Name: Ming Xie, MD
- Phone Number: +8615519202000
- Email: 2581303091@qq.com
Study Locations
-
-
Guizhou
-
Zunyi, Guizhou, China, 563000
- Recruiting
- Affiliated Hospital of Zunyi Medical University
-
Contact:
- Ming Xie, MD
- Phone Number: +8615519202000
- Email: 2581303091@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The inclusion criteria were as follows: (1) patients aged between 18 and 80 years; (2) histopathology confirmed as colorectal adenocarcinoma; (3) preoperative imaging (CT and MR) assessments showed that colorectal cancer did not penetrate the serosa (≤T3); (4) tumor circumference <5 cm; (5) enhanced chest and abdominal pelvic CT scans before operation excluded liver metastasis, lung metastasis, and other distant organ metastases.
Exclusion Criteria:
- The preoperative exclusion criteria were as follows: (1) tumors could be resected by endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR); (2) body mass index (BMI) > 30 kg/m2; (3) patients with severe perforation, bleeding, or obstruction requiring emergency surgery; (4) recurrent cases; (5) patients undergoing neoadjuvant therapy or preoperative radiotherapy; (6) Anesthesiologists (ASA) score ≥ IV; (7) active period of infection; (8) blood neutrophils <3 × 109/L.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Natural Orifice Specimen Extraction Surgery
|
NOSES:Natural orifice specimen extraction (NOSE) is the opening of a hollow viscus that already communicates with the outside world, such as the vagina or distal gastrointestinal tract, in order to remove a specimen. The premise of this technique is to reduce the trauma required to remove the specimen with the expectation that this may improve outcomes. Conventional Laparoscopic Surgery:Surgical specimens were taken out through abdominal wall.
Other Names:
|
SHAM_COMPARATOR: Conventional laparoscopy
|
NOSES:Natural orifice specimen extraction (NOSE) is the opening of a hollow viscus that already communicates with the outside world, such as the vagina or distal gastrointestinal tract, in order to remove a specimen. The premise of this technique is to reduce the trauma required to remove the specimen with the expectation that this may improve outcomes. Conventional Laparoscopic Surgery:Surgical specimens were taken out through abdominal wall.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative complications
Time Frame: One month after operation
|
pulmonary infection,Urinary tract infection,anal function,intestinal obstruction,Anastomotic bleeding,etc.
|
One month after operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
survival
Time Frame: 3-year and 5-year after operation
|
3-year and 5-year Overall survival rate
|
3-year and 5-year after operation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WA2020RW12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI); AmgenTerminatedStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer...United States
Clinical Trials on Laparoscopic Surgery
-
University Hospital, GrenobleCompleted
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Fujian Medical UniversityCompleted
-
Fujian Medical UniversityEnrolling by invitation
-
Shoichi Fujii, MD, PhDUnknownColorectal CancerJapan
-
Ruijin HospitalRecruiting
-
First Affiliated Hospital Xi'an Jiaotong UniversityAir Force Military Medical University, ChinaUnknownGastrointestinal Stromal TumorsChina
-
University Hospital TuebingenInstitute of Occupational and Social Medicine and Health Services Research...RecruitingMusculoskeletal Diseases or ConditionsGermany
-
Ruijin HospitalActive, not recruiting
-
The Second Affiliated Hospital of Chongqing Medical...UnknownLaparoscopic SurgeryChina
-
First Affiliated Hospital Xi'an Jiaotong UniversityUnknownGastrointestinal Stromal TumorChina