Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer

NCT06362902 | Recruiting

• 1 other identifier: NOSES-VIII B
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer

Keywords

Colon cancer; Laparoscopic Right Hemicolectomy; Natural orifice specimen extraction surgery

Outcome Measures

Primary Outcomes (1)

• The rate of postoperative complications

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

  up to 30 days

Secondary Outcomes (4)

• Operating time

  up to 1 days

• Estimated blood loss

  up to 1 days

• The time of first flatus

  up to 5 days

• Postoperative hospitalization

  up to 30 days

Study Arms (1)

Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction

EXPERIMENTAL

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 The stapler was fired and withdrawn, and the common enterotomy was sealed by using another linear stapler.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.

Procedure: Laparoscopic right hemicolectomy with transrectal specimen extraction

Interventions

Laparoscopic right hemicolectomy with transrectal specimen extraction PROCEDURE

Laparoscopic right hemicolectomy with transrectal specimen extraction

Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• National Cancer Center, China: lead

Study Sites (1)

National Cancer Center

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Haitao Zhou, M.D.

  National Cancer Center, China

  STUDY CHAIR

Central Study Contacts

Zheng Xu, M.D.

CONTACT

+8618800157037; 1206164395@qq.com

Yueyang Zhang, M.D.

CONTACT

+8613552910035; yyzhang0129@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)