Extended bowel resection for rectal cancer after radiotherapy
Effect of Splenic Flexure Mobilization With Extended Resection of the Proximal Colon for Rectal Cancer With Neoadjuvant Radiotherapy on Postoperative Complications
NA · Qilu Hospital of Shandong University · NCT05267275
This study tests if a new surgery technique can help people with mid-low rectal cancer who have had radiation treatment by using healthy bowel to reduce complications after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05267275 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of extended resection of the proximal bowel with splenic flexure mobilization in patients with mid-low rectal cancer who have undergone preoperative neoadjuvant therapy. The aim is to address complications related to rectal anastomosis that may arise due to radiation damage to the pelvic bowel. By using healthy proximal bowel for anastomosis, the study seeks to reduce the incidence of complications such as leakage and stenosis. Participants will be closely monitored for surgical outcomes and complications.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-75 with mid-low rectal cancer who have received preoperative neoadjuvant therapy and meet specific health criteria.
Not a fit: Patients with a history of other malignant tumors or severe underlying diseases that prevent them from tolerating surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce complications associated with rectal anastomosis in patients undergoing treatment for rectal cancer.
How similar studies have performed: While the approach of extended resection is not widely tested, similar strategies in managing complications from neoadjuvant therapy have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (RECRUITING)
Study contacts
- Study coordinator: Yanlei Wang
- Email: yanleiwang@hotmail.com
- Phone: +8618560085128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant Therapy