Extended Resection for Rectal Cancer With Neoadjuvant Radiotherapy

Not Applicable

Recruiting

• Conditions: the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant Therapy
• Interventions: Procedure: extended resection with splenic flexure mobilization

• Registration Number: NCT05267275
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-30
• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-23
• Last Update Submitted: 2022-02-23
• Study First Posted: 2022-03-04
• Last Update Posted: 2022-03-04
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients with mid-low rectal cancer who received preoperative neoadjuvant therapy (tumor distance ≤12cm from the anus);
2. 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)
3. Preoperative neoadjuvant therapy (long-course concurrent chemoradiation or TNT)
4. Aged between 18-75 years old;
5. ASA rating: 0-2
6. ECOG Score: 0-2
7. BMI 18-30 kg/m2;
8. Radical surgical resection is expected to be possible on the basis of preserving the anus;
9. Sign the informed consent document.

Exclusion Criteria

1. History of other malignant tumors;
2. Emergency surgery patients;
3. Severe underlying diseases, unable to tolerate surgery;
4. Without informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
extended resection with splenic flexure mobilization	extended resection with splenic flexure mobilization	-

Primary Outcome Measures

Name	Time	Method
incidence of complications related to rectal anastomosis	From the end of the surgery to 1 year after ileostomy closure

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China