Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer

Colon Cancer Clinical Trial

Official title:

Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06362902
• Other study ID #: NOSES-VIII B
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: April 2024
• Source: National Cancer Center, China
• Contact: Zheng Xu, M.D.
• Phone: +8618800157037
• Email: 1206164395[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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. Maximal tumor diameter =5 cm;

5. Body mass index (BMI) =30 kg/m2;

6. 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;

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Procedure:
• Laparoscopic right hemicolectomy with transrectal specimen extraction
Laparoscopic right hemicolectomy with transrectal specimen extraction

Locations

Country	Name	City	State
China	National Cancer Center	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of postoperative complications	The rate of postoperative complications = patients with any postoperative complications/all cases.	up to 30 days
Secondary	Operating time	Operating time = The Operative time was defined as the time first skin incision was made to final skin closure	up to 1 days
Secondary	Estimated blood loss	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)	up to 1 days
Secondary	The time of first flatus	The time of first flatus = The time of first flatus reported by patients	up to 5 days
Secondary	Postoperative hospitalization	Postoperative hospitalization = the number of nights from surgery to discharge	up to 30 days