Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer

Not Applicable

Recruiting

• Conditions: Colon Cancer

• Registration Number: NCT06362902
• Lead Sponsor: National Cancer Center, China

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.

Detailed 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.

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 37

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The rate of postoperative complications	up to 30 days	The rate of postoperative complications = patients with any postoperative complications/all cases.

Secondary Outcome Measures

Name	Time	Method
Operating time	up to 1 days	Operating time = The Operative time was defined as the time first skin incision was made to final skin closure
Estimated blood loss	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)
The time of first flatus	up to 5 days	The time of first flatus = The time of first flatus reported by patients
Postoperative hospitalization	up to 30 days	Postoperative hospitalization = the number of nights from surgery to discharge

Trial Locations

Locations (1)

National Cancer Center; 🇨🇳 Beijing, Beijing, China