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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06753968
Enrollment
349
Registered
2024-12-31
Start date
2018-01-01
Completion date
2024-08-01
Last updated
2024-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

colon cancer, totallly laparoscopic right hemicolectomy, natural orifice specimen extraction surgery

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.

Interventions

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

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. Similarly, transrectal extraction 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.

PROCEDURETotally laparoscopic right hemicolectomy (TLRH)

Totally laparoscopic right hemicolectomy (TLRH), which involves performing intracorporeal anastomosis and specimen extraction through a small abdominal incision, further 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.

Sponsors

National Cancer Center, China
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
The rate of postoperative complicationsup to 30 daysThe rate of postoperative complications = patients with any postoperative complications/all cases.

Secondary

MeasureTime frameDescription
Operating timeup to 1 daysOperating time = The Operative time was defined as the time first skin incision was made to final skin closure
The time of first flatusup to 5 daysThe time of first flatus = The time of first flatus reported by patients
Postoperative hospitalizationup to 30 daysPostoperative hospitalization = the number of nights from surgery to discharge

Other

MeasureTime frameDescription
Estimated blood lossup to 1 daysEstimated 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)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026