Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer

N

National Cancer Center, China

Status

Enrolling

Conditions

Colon Cancer

Treatments

Procedure: Laparoscopic right hemicolectomy with transrectal specimen extraction

Study type

Interventional

Funder types

Other

Identifiers

NCT06362902
NOSES-VIII B

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;
  • Maximal tumor diameter ≤5 cm;
  • Body mass index (BMI) ≤30 kg/m2;
  • 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;

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

37 participants in 1 patient group

Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction
Experimental group
Description:
STEP 1: Dissection and separation The mesentery and vessels were dissected and separated according to the principle of complete mesocolic excision. STEP 2: Intracorporeal anastomosis An enterotomy was performed on the antimesenteric side of the ileum at the edge of the staple line. This maneuver was replicated on the transverse colic side. Subsequently, the cartridge jaw of the stapler was inserted into the transverse colon. The stapler was fired and withdrawn, and the common enterotomy was sealed by using another linear stapler. STEP 3: Transrectal specimen extraction A longitudinal incision was made on the anterior of wall of the upper rectum. The assistant employed oval forceps to extract the specimen along with the protective sleeve through the incision in the upper rectum. After the complete extraction of the specimen, a full-layer running suturing was performed to close the incision.
Treatment:
Procedure: Laparoscopic right hemicolectomy with transrectal specimen extraction

Trial contacts and locations

1

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Central trial contact

Zheng Xu, M.D.; Yueyang Zhang, M.D.

Data sourced from clinicaltrials.gov

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