| Registry | NCT07825766 |
|---|---|
| Status | Active not recruiting |
| Study type | Observational |
| Enrollment | 200 (Estimated) |
| Sponsor | Fudan University (Other) |
| Conditions | Colon Cancer, Nerve Preserve |
| Interventions | Abdominal autonomic nerve preserverd in the TNP arm (Procedure) |
| Dates | start 2026-07-01, primary completion 2027-09-01 (estimated), completion 2028-09-01 (estimated), first posted 2026-09-17, last updated 2026-09-17 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Colon Cancer All trials for Nerve Preserve All trials of Abdominal autonomic nerve preserverd in the TNP arm
Preservation of pelvic autonomic nerves to retain genitourinary function without compromise of oncologic clearance of tumor has been extensively studied in rectal cancer surgery. However, there is still not much information about preservation of autonomic nerves after colectomy for right and left colon cancer. Because the abdominal deep-seated neural structures, such as abdominal plexus (superior hypogastric plexus), neurovascular bundles of SMA, SMV and IMV were within the boundary of dissection, traditional colectomy for right and left colon cancer extended simultaneous dissection of the lateral bundles and entire circle of the neural plexuses surrounding the SMV and IMV. However, a severe and persistent diarrhea, enterospasm, or enteroparalysis developed in almost some patients. It is therefore opinion that during the colectomy for right and left colon cancer, preservation of autonomic nerves may be a priority-that is, autonomic nerve preservation is appropriate unless there are oncologic reasons for the resection of nerves. Therefore, the investigators conducted the present study to test the feasibility of laparoscopic approach in performing the total abdominal autonomic nerve preservation during the standard oncologic resection of right/left colon cancer. The investigators hypothesized that given a well-illuminated magnified view by laparoscopy, the autonomic nerves can be well protected from inadvertent surgical damage. Therefore, the investigators aimed to compare the efficacy and safety of the total abdominal autonomic nerve preservation (TNP) versus traditional CME of right/left colon cancer.
This prospective controlled trial was done in FUSCC. Eligible patients were aged 18-75 years with histologically confirmed primary adenocarcinoma located between the caecum and the descending colon, without evidence of distant metastases. Participants were randomly assigned (1:1) to TNP or CME during laparoscopic right/left colectomy. Abdominal autonomic nerve were dissected in the CME but not in the TNP procedure. Neither investigators nor participants were masked to their group assignment but the quality control committee were masked to group assignment. The primary endpoint was postoperative bowel function recovery, including defecation frequency, diarrhea and enterospasm; The secondary outcomes were 3-year disease-free survival, intraoperative surgical complications and postoperative complications within 30 days of surgery, graded according to the Clavien-Dindo classification, mortality (death from any cause within 30 days of surgery), and central lymph node metastasis rate.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| TNP :Abdominal autonomic nerve were preseverd in the colectomy for right and left colon cancer | Procedure: Abdominal autonomic nerve preserverd in the TNP arm | Abdominal autonomic nerve were preseverd in the colectomy for right and left colon cancer | |
| traditional CME | Abdominal autonomic nerve were dissected in the CME |
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria: * 18-75 years old * Pathologically confirmed adenocarcinoma of right side of colon and descending colon. * Localization of the tumor ranging from the cecum to the descending colon * Tumors clinically staged as T2-4aN0M0 or TanyN + M0, according to imaging studies including enhanced computed tomography (CT) scan, magnetic resonance imaging (MRI), etc. * American Society of Anesthesiologists (ASA) score of I, II, or III. Exclusion Criteria: * Synchronous or metachronous multiple primary colorectal cancer * Preoperative imaging examination shows enlargement of the central lymph nodes, which mandates a D3 lymphadenectomy * Preoperative imaging examination shows that the tumor involves the adjacent organs, requiring combined multiple organ resections, or radical excision (R0 resection) is not possible * History of any other malignant tumor in past 5 years, except for cervical carcinoma in situ that has been cured, basal cell carcinoma, or squamous cell carcinoma of skin * Patients who need an emergency operation * Patients who are not suitable to undergo laparoscopic surgery (due to, e.g., extensive adhesion caused by prior abdominal surgery, inability to endure artificial pneumoperitoneum, etc.).
| Facility | City | Country | Status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai, Shanghai Municipality | China |