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Completed

NCT Number: NCT06753968

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Center, Beijing, Beijing 100000

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy proven colon carcinoma;
  • Imaging diagnosis of T1-3 colon cancer;
  • The tumor located in the cecum, ascending colon, or colonic hepatic flexure;
  • Written informed consent;

Exclusion criteria

  • Complete intestinal obstruction;
  • Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);
  • 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;
  • Pregnancy or breastfeeding;
  • Alcohol abuse or drug addiction;
  • Concurrent uncontrolled medical condition;

Treatment and study plan

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

Procedure

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.

Totally laparoscopic right hemicolectomy (TLRH)

Procedure

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.

Primary outcomes

  1. The rate of postoperative complications

    Time frame: up to 30 days

    The rate of postoperative complications = patients with any postoperative complications/all cases.

Secondary outcomes

  1. Operating time

    Time frame: up to 1 days

    Operating time = The Operative time was defined as the time first skin incision was made to final skin closure

  2. The time of first flatus

    Time frame: up to 5 days

    The time of first flatus = The time of first flatus reported by patients

  3. Postoperative hospitalization

    Time frame: up to 30 days

    Postoperative hospitalization = the number of nights from surgery to discharge

Other outcomes

  1. Estimated blood loss

    Time frame: up to 1 days

    Estimated 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)

Sponsors and collaborators

Lead sponsor

National Cancer Center, China

Other

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Dec 31, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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