Extended Resection for Rectal Cancer With Neoadjuvant Radiotherapy

February 23, 2022 updated by: Qilu Hospital of Shandong University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital Of Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: extended resection with splenic flexure mobilization
Procedure: extended 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of complications related to rectal anastomosis
Time Frame: From the end of the surgery to 1 year after ileostomy closure
From the end of the surgery to 1 year after ileostomy closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2021

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

February 23, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202111-226

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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