Clinical trial NCT06362902: Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer
Official title: Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Cancer
Keywords: Colon cancer
Laparoscopic Right Hemicolectomy
Natural orifice specimen extraction surgery
Lead sponsor: National Cancer Center, China
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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;

Primary outcomes:
measure: The rate of postoperative complications
timeFrame: up to 30 days
Secondary outcomes:
measure: Operating time
timeFrame: up to 1 days
measure: Estimated blood loss
timeFrame: up to 1 days
measure: The time of first flatus
timeFrame: up to 5 days
measure: Postoperative hospitalization
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Cancer Center
state: Beijing
Study officials:
affiliation: National Cancer Center, China
name: Haitao Zhou, M.D.
role: STUDY_CHAIR
References: