Skip to content

Extended Resection for Rectal Cancer With Neoadjuvant Radiotherapy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05267275
Enrollment
40
Registered
2022-03-04
Start date
2021-11-30
Completion date
2025-12-31
Last updated
2022-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant Therapy

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.

Interventions

PROCEDUREextended resection with splenic flexure mobilization

During the operation, the splenic flexure of the colon was first freed, and then the physiological adhesion site of the sigmoid colon was located. Routine laparoscopic or open rectal cancer radical resection (D3 dissection + high ligation) was performed. The proximal end of the colon is disconnected 10-15cm away from the physiological adhesion site of the sigmoid colon. The anastomosis method was manual anastomosis or stapler anastomosis, and a prophylactic ileal loop ostomy was routinely performed.

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
incidence of complications related to rectal anastomosisFrom the end of the surgery to 1 year after ileostomy closure

Countries

China

Contacts

Primary ContactYanlei Wang
yanleiwang@hotmail.com+8618560085128

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026