Clinical trial NCT06753968: The Role of Natural Orifice Specimen Extraction Surgery (NOSES) in Treating Right-sided Colon Cancer
Official title: The Role of Natural Orifice Specimen Extraction Surgery (NOSES) in Treating Right-sided Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: colon cancer
totallly laparoscopic right hemicolectomy
natural orifice specimen extraction surgery
Lead sponsor: National Cancer Center, China
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the short-term and long-term outcomes between natural orifice specimen extraction surgery (NOSES) and totally laparoscopic right hemicolectomy (TLRH). The hypothesis is that NOSES could achieve good short-term and oncological outcomes for right colon cancer patients.

Detailed description: This study is a retrospective clinical study. We reviewed collected data from all patients who underwent laparoscopic curative resection for stage I-III right-sided colon cancer between January 2018 and January 2023. A total of consecutive 115 patients who underwent laparoscopic resection with transvaginal or transrectal specimen extraction were identified as the NOSES group. To establish a comparative cohort, 234 patients who underwent totally laparoscopic right hemicolectomy (TLRH) during the same period were selected. The purpose of this study is to investigate the short-term and long-term outcomes between NOSES and TLRH. The hypothesis is that NOSES could promote postoperative recovery, reduce incision-related complications with comaprable long-term oncological outcomes when compared with TLRH.

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. 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: The time of first flatus
timeFrame: up to 5 days
measure: Postoperative hospitalization
timeFrame: up to 30 days
Other outcomes:
measure: Estimated blood loss
timeFrame: up to 1 days
Locations:
city: Beijing
country: China
facility: National Cancer Center, Beijing, Beijing 100000
Study officials:
References:
citation: Li XW, Wang CY, Zhang JJ, Ge Z, Lin XH, Hu JH. Short-term efficacy of transvaginal specimen extraction for right colon cancer based on propensity score matching: A retrospective cohort study. Int J Surg. 2019 Dec;72:102-108. doi: 10.1016/j.ijsu.2019.07.025. Epub 2019 Jul 27.