Colon CancerNCT07825766
The Role of Total Abdominal Autonomic Nerve Preservation During the Resection of Right/Left Colon Cancer: Prospective Clinical Trial
An observational study of Colon Cancer and Nerve Preserve, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer, Nerve Preserve
- What is being tested?
- Abdominal autonomic nerve preserverd in the TNP arm
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 1 Sep 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pathologically confirmed adenocarcinoma of right side of colon and descending colon.
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200030
About this study
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.
Read the detailed description
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.
- Conditions
- Colon Cancer, Nerve Preserve
- Being tested
- Abdominal autonomic nerve preserverd in the TNP arm
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal autonomic nerve preserverd in the TNP armProcedure or surgery
Abdominal autonomic nerve is preserverd in colectomy for right and left colon cancer.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Abdominal autonomic nerve preserverd in the TNP arm | |
| traditional CME | Abdominal autonomic nerve were dissected in the CME |
What is being measured
The primary outcome is the main question the study is designed to answer.
defecation frequency
defecation frequency
Measured: one year
diarrhea
diarrhea frequency
Measured: 1 year
enterospasm
enterospasm frequency
Measured: 1 year
Secondary outcomes (1)
oncological outcome
3-year disease-free survival
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Jul 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junjie Peng, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825766
- Sponsor's protocol ID
- TNP trial
- Status last verified
- Aug 2026
- First submitted
- 7 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: baseline data
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Total Abdominal Autonomic Nerve Preservation During the Resection of Right/Left Colon Cancer: Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT07825766
- Acronym / sponsor ID
- TNP trial
- Conditions
- Colon Cancer, Nerve Preserve
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNP :Abdominal autonomic nerve were preseverd in the colectomy for right and left colon cancer | – | Procedure: Abdominal autonomic nerve preserverd in the TNP armAbdominal autonomic nerve were preseverd in the colectomy for right and left colon cancer |
| traditional CME | – | –Abdominal autonomic nerve were dissected in the CME |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pathologically confirmed adenocarcinoma of right side of colon and descending colon.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal autonomic nerve preserverd in the TNP armAbdominal autonomic nerve is preserverd in colectomy for right and left colon cancer. | Procedure or surgery | TNP :Abdominal autonomic nerve were preseverd in the colectomy for right and left colon cancer |
Primary outcome
defecation frequency
Time frame: one year
defecation frequency
diarrhea
Time frame: 1 year
diarrhea frequency
enterospasm
Time frame: 1 year
enterospasm frequency
1 secondary outcome
oncological outcome
Time frame: 3-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. baseline data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Nerve Preserve, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
defecation frequency (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.