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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06362902
Other study ID # NOSES-VIII B
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date September 1, 2025

Study information

Verified date April 2024
Source National Cancer Center, China
Contact Zheng Xu, M.D.
Phone +8618800157037
Email 1206164395@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 37
Est. completion date September 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Laparoscopic right hemicolectomy with transrectal specimen extraction
Laparoscopic right hemicolectomy with transrectal specimen extraction

Locations

Country Name City State
China National Cancer Center Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Center, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of postoperative complications The rate of postoperative complications = patients with any postoperative complications/all cases. up to 30 days
Secondary Operating time Operating time = The Operative time was defined as the time first skin incision was made to final skin closure up to 1 days
Secondary Estimated blood loss Estimated blood loss = The sum of the blood in the suction canister (the total volume after subtracting the amount of irrigation fluid used) and the segment of increased weight of swabs used during operation phase (1 ml of blood is about weighs 1g) up to 1 days
Secondary The time of first flatus The time of first flatus = The time of first flatus reported by patients up to 5 days
Secondary Postoperative hospitalization Postoperative hospitalization = the number of nights from surgery to discharge up to 30 days
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