Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer

Last updated: April 8, 2024
Sponsor: National Cancer Center, China
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer

Treatment

Laparoscopic right hemicolectomy with transrectal specimen extraction

Clinical Study ID

NCT06362902
NOSES-VIII B
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Complete intestinal obstruction;
  2. Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudomeningitis, motor neuritis, and sensory impairment);
  3. Significant organ dysfunction or other significant diseases, including clinicallyrelevant coronary artery disease, cardiovascular disease, or myocardial infarctionwithin 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

Total Participants: 37
Treatment Group(s): 1
Primary Treatment: Laparoscopic right hemicolectomy with transrectal specimen extraction
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
September 01, 2025

Study 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.

Connect with a study center

  • National Cancer Center

    Beijing, Beijing 100000
    China

    Active - Recruiting

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