The Role of Natural Orifice Specimen Extraction Surgery (NOSES) in Treating Right-sided Colon Cancer

National Cancer Center, China

Status: Completed

Conditions: Colon Cancer

Treatments: Procedure: Laparoscopic Right Hemicolectomy With Transrectal/transvaginal Specimen Extraction (NOSES); Procedure: Totally laparoscopic right hemicolectomy (TLRH)

Study type: Interventional

Funder types: Other

Identifiers

NCT06753968

NOSES for right hemicolectomy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 349 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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349 participants in 2 patient groups

Laparoscopic Right Hemicolectomy With Transrectal/transvaginal Specimen Extraction (NOSES)

Experimental group

Description:

The NOSES group employs two distinct methods for specimen extraction, both of which have been thoroughly outlined in previous studies. The first method, transvaginal extraction, begins with the irrigation and disinfection of the vagina, followed by a transverse incision in the posterior fornix. The assistant then utilizes oval forceps to carefully extract the specimen bag through the incision, which is subsequently closed with continuous full-thickness sutures, using barbed sutures to ensure secure closure. The second method, transrectal extraction, similarly begins with irrigation of the rectum using a dilute iodine solution, followed by a longitudinal incision along the anterior wall of the upper rectum. The specimen, along with the protective sleeve, is then removed using oval forceps, and the incision is closed with a continuous full-layer running suture once the specimen has been completely extracted.

Treatment:

Procedure: Laparoscopic Right Hemicolectomy With Transrectal/transvaginal Specimen Extraction (NOSES)

Totally Laparoscopic Right Hemicolectomy (TLRH)

Active Comparator group

Description:

Totally Laparoscopic Right Hemicolectomy (TLRH), which involves performing intracorporeal anastomosis and specimen extraction through a small abdominal incision, enhances the benefits of minimally invasive surgery In the TLRH group, following the stapled side-to-side anastomosis, a small horizontal incision is made about 2 to 3 cm above the symphysis pubis, at the junction of the pubic hairline, to allow for specimen removal.

Treatment:

Procedure: Totally laparoscopic right hemicolectomy (TLRH)