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Clinical Trials/NCT05267275
NCT05267275
Recruiting
Not Applicable

Effect of Splenic Flexure Mobilization With Extended Resection of the Proximal Colon for Rectal Cancer With Neoadjuvant Radiotherapy on Postoperative Complications

Qilu Hospital of Shandong University1 site in 1 country40 target enrollmentNovember 30, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant Therapy
Sponsor
Qilu Hospital of Shandong University
Enrollment
40
Locations
1
Primary Endpoint
incidence of complications related to rectal anastomosis
Status
Recruiting
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 30, 2021
End Date
December 2025
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

incidence of complications related to rectal anastomosis

Time Frame: From the end of the surgery to 1 year after ileostomy closure

Study Sites (1)

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