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Extended Resection for Rectal Cancer With Neoadjuvant Radiotherapy

Primary Purpose

the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant Therapy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
extended resection with splenic flexure mobilization
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant Therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Qilu Hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

extended resection with splenic flexure mobilization

Arm Description

Outcomes

Primary Outcome Measures

incidence of complications related to rectal anastomosis

Secondary Outcome Measures

Full Information

First Posted
February 23, 2022
Last Updated
February 23, 2022
Sponsor
Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT05267275
Brief Title
Extended Resection for Rectal Cancer With Neoadjuvant Radiotherapy
Official Title
Effect of Splenic Flexure Mobilization With Extended Resection of the Proximal Colon for Rectal Cancer With Neoadjuvant Radiotherapy on Postoperative Complications
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
the Incidence of Complications Related to Rectal Anastomosis After Neoadjuvant Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
extended resection with splenic flexure mobilization
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
extended resection with splenic flexure mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
incidence of complications related to rectal anastomosis
Time Frame
From the end of the surgery to 1 year after ileostomy closure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanlei Wang
Phone
+8618560085128
Email
yanleiwang@hotmail.com
Facility Information:
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanlei Wang
Phone
+8618560085128
Email
yanleiwang@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Extended Resection for Rectal Cancer With Neoadjuvant Radiotherapy

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