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NCT Number: NCT07825766

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Abdominal autonomic nerve preserverd in the TNP arm

Procedure

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

Primary outcomes

  1. defecation frequency

    Time frame: one year

    defecation frequency

  2. diarrhea

    Time frame: 1 year

    diarrhea frequency

  3. enterospasm

    Time frame: 1 year

    enterospasm frequency

Secondary outcomes

  1. oncological outcome

    Time frame: 3-year

    3-year disease-free survival

Other outcomes

  1. surgical complications

    Time frame: 30 days

    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

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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