The Role of Total Abdominal Autonomic Nerve Preservation During the Resection of Right/Left Colon Cancer: Prospective Clinical Trial

NCT07825766 | Active Not Recruiting DMC

• 1 other identifier: TNP trial
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer; Nerve Preserve

Outcome Measures

Primary Outcomes (3)

• defecation frequency

  defecation frequency

  one year

• diarrhea

  diarrhea frequency

  1 year

• enterospasm

  enterospasm frequency

  1 year

Secondary Outcomes (1)

• oncological outcome

  3-year

Other Outcomes (1)

• surgical complications

  30 days

Study Arms (2)

TNP :Abdominal autonomic nerve were preseverd in the colectomy for right and left colon cancer

Abdominal autonomic nerve were preseverd in the colectomy for right and left colon cancer

Procedure: Abdominal autonomic nerve preserverd in the TNP arm

traditional CME

Abdominal autonomic nerve were dissected in the CME

Interventions

Abdominal autonomic nerve preserverd in the TNP arm PROCEDURE

Abdominal autonomic nerve is preserverd in colectomy for right and left colon cancer.

TNP :Abdominal autonomic nerve were preseverd in the colectomy for right and left colon cancer

Eligibility Criteria

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

Study Population

Pathologically confirmed adenocarcinoma of right side of colon and descending colon.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200030, China

Location

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 Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)