Extended Resection for Rectal Cancer With Neoadjuvant Radiotherapy

  • STATUS
    Recruiting
  • End date
    Dec 10, 2025
  • participants needed
    40
  • sponsor
    Qilu Hospital of Shandong University
Updated on 10 March 2022

Summary

Preoperative neoadjuvant therapy has become the guideline-recommended standard treatment for patients with locally advanced or mid-to-low rectal cancer with suspected regional lymph node metastasis. However, preoperative neoadjuvant radiotherapy caused radiation damage to the pelvic bowel, resulting in varying degrees of edema, vascular stiffness, and insufficient blood supply. According to the traditional rectal cancer surgery, the proximal bowel resection only needs to be more than 10cm above the upper edge of the tumor. However, this range of resection cannot remove all the damaged proximal bowel, and using the damaged proximal bowel for anastomosis may lead to the risk of anastomotic-related complications (including anastomotic leakage, anastomotic stenosis, and anastomotic proximal bowel stiffness, etc.) also increased. Therefore, extended resection of the proximal bowel with splenic flexure mobilization and using healthy proximal bowel for anastomosis may help reduce the incidence of complications related to rectal anastomosis after neoadjuvant therapy.

Details
Condition the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant Therapy
Treatment extended resection with splenic flexure mobilization
Clinical Study IdentifierNCT05267275
SponsorQilu Hospital of Shandong University
Last Modified on10 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with mid-low rectal cancer who received preoperative neoadjuvant therapy (tumor distance ≤12cm from the anus)
The preoperative local stage is cT3-4N0-2M0 or cT3-4N0-2M1 (M1 is limited to liver metastases that can be surgically removed at the same time)
Preoperative neoadjuvant therapy (long-course concurrent chemoradiation or TNT)
Aged between 18-75 years old
ASA rating: 0-2
ECOG Score: 0-2
BMI 18-30 kg/m2
Radical surgical resection is expected to be possible on the basis of preserving the anus
Sign the informed consent document

Exclusion Criteria

History of other malignant tumors
Emergency surgery patients
Severe underlying diseases, unable to tolerate surgery
Without informed consent
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note