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Trial Title:
Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer
NCT ID:
NCT06362902
Condition:
Colon Cancer
Conditions: Official terms:
Colonic Neoplasms
Conditions: Keywords:
Colon cancer
Laparoscopic Right Hemicolectomy
Natural orifice specimen extraction surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Laparoscopic right hemicolectomy with transrectal specimen extraction
Description:
Laparoscopic right hemicolectomy with transrectal specimen extraction
Arm group label:
Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction
Summary:
The purpose of this study is to investigate the preliminary surgical outcomes of
laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is
that this type of natural orifice specimen extraction surgery (NOSES) could achieve good
short-term and oncological outcomes for right colon cancer patients.
Detailed description:
This study is a prospective single-arm clinical study. 37 patients with right colon
cancer undergoing laparoscopic right hemicolectomy with transrectal specimen extraction
are planned to be included in the study. The purpose of this study is to investigate the
preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal
specimen extraction. The primary endpoint is the postoperative complications of this type
of natural orifice specimen extraction surgery (NOSES). The primary hypothesis is that
NOSES could reduce postoperative complications. In addition, operating time,
intraoperative bleeding, post-operative recovery and quality of life (QoL) are secondary
endpoints.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Biopsy proven colon carcinoma;
2. Imaging diagnosis of T1-3 colon cancer;
3. The tumor located in the cecum, ascending colon, or colonic hepatic flexure;
4. Maximal tumor diameter ≤5 cm;
5. Body mass index (BMI) ≤30 kg/m2;
6. Written informed consent;
Exclusion Criteria:
1. Complete intestinal obstruction;
2. Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo
meningitis, motor neuritis, and sensory impairment);
3. Significant organ dysfunction or other significant diseases, including clinically
relevant coronary artery disease, cardiovascular disease, or myocardial infarction
within the 12 months before enrollment; severe neurological or psychiatric history;
severe infection; active disseminated intravascular coagulation;
4. Pregnancy or breastfeeding;
5. Alcohol abuse or drug addiction;
6. Concurrent uncontrolled medical condition;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Haitao Zhou, M.D.
Phone:
+8613381167333
Email:
zhouhaitao01745@163.com
Contact backup:
Last name:
Yueyang Zhang, M.D.
Phone:
+8613552910035
Email:
yyzhang0129@163.com
Start date:
March 1, 2024
Completion date:
September 1, 2025
Lead sponsor:
Agency:
National Cancer Center, China
Agency class:
Other
Source:
National Cancer Center, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06362902
