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PR in Endoscopic LAR for Rectal Cancer

Primary Purpose

Rectal Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Pelvic floor Reconstruction

About this trial

This is an interventional treatment trial for Rectal Carcinoma focused on measuring minimally invasive surgical

Eligibility Criteria

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

Inclusion Criteria:

patients with histologically proven rectal adenocarcinoma
tumor located in the middle and lower rectum and anastomosis under the peritoneal reflection
Tumor assessed as a depth of invasion that was confined to pT1-pT3, bN0-1M0 by ultrasound colonoscopy and/or pelvic MRI
Negative circumferential resection margin confirmed by MRI
Performance status (ECOG) 0~1
Written informed consent for participation in the trial

Exclusion Criteria:

History of accepting lower abdominal surgery.
More than one colorectal tumor
Patients with unresectable distant metastasis or multiple metastases
Received neoadjuvant radiotherapy before surgery
Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
Patients and/or family members cannot understand and accept this study
Non-rectal adenocarcinoma was confirmed by postoperative pathological examination

Sites / Locations

General Surgery Center of PLARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Non-PR

Arm Description

Outcomes

Primary Outcome Measures

The rate of anastomotic leakage after laparoscopic anterior resection for rectal cancer

Re-operation rate after anastomotic leakage

The rate of general complications

Secondary Outcome Measures

Operative time

Postoperative hospital stay

Incidence of defecation dysfunction

3-year local recurrence rate

5-year disease-free survival

Postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire

Blood loss

White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample

Full Information

NCT ID

NCT04078828

First Posted

August 15, 2019

Last Updated

November 28, 2021

Sponsor

Southwest Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT04078828

Brief Title

PR in Endoscopic LAR for Rectal Cancer

Official Title

Pelvic Floor Reconstruction (PR) in Endoscopic Low Anterior Resection for Rectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

August 1, 2020 (Actual)

Study Completion Date

April 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Southwest Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The anastomotic leakage remains the major early complication after laparoscopic anterior resection(LAR) for medium & low rectal cancer. Pelvic floor reconstruction (PR) is a key step in various standard resections for open radical rectal cancer surgery, which was considered to be helpful for decreasing the rate of leakage. However, PR in endoscopic LAR surgery is not routine practice and remains controversial. The purpose of this study is to evaluate the efficacy of PR during LAR for mid/low rectal carcinoma, especially in preventing anastomotic leakage.

Detailed Description

Eligible patients with rectal cancer will be randomly assigned to group with pelvic floor reconstruction(PR) versus group without pelvic floor reconstruction(NPR). We want to investigate the rate of anastomotic leakage and re-operation between the two groups, some other relevant outcomes will be concerned all the same.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Carcinoma

Keywords

minimally invasive surgical

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Non-PR

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Pelvic floor Reconstruction

Intervention Description

Pelvic floor Reconstruction after laparoscopic anterior resection and double-stapling technique anastomosis were finished.

Primary Outcome Measure Information:

Title

The rate of anastomotic leakage after laparoscopic anterior resection for rectal cancer

Time Frame

30 days after surgery

Title

Re-operation rate after anastomotic leakage

Time Frame

30 days after surgery

Title

The rate of general complications

Time Frame

30 days after surgery

Secondary Outcome Measure Information:

Title

Operative time

Time Frame

Operation day

Title

Postoperative hospital stay

Time Frame

1 year after surgery

Title

Incidence of defecation dysfunction

Time Frame

From the date of operation until the date of complication,assessed up to 3 years

Title

3-year local recurrence rate

Time Frame

From date of operation until the date of local-recurrence (up to 3 years)

Title

5-year disease-free survival

Time Frame

From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Title

Postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire

Time Frame

1 year after operation

Title

Blood loss

Time Frame

Operation day

Title

White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample

Time Frame

1 days after surgery

Title

White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample

Time Frame

3 days after surgery

Title

White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample

Time Frame

5 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients with histologically proven rectal adenocarcinoma tumor located in the middle and lower rectum and anastomosis under the peritoneal reflection Tumor assessed as a depth of invasion that was confined to pT1-pT3, bN0-1M0 by ultrasound colonoscopy and/or pelvic MRI Negative circumferential resection margin confirmed by MRI Performance status (ECOG) 0~1 Written informed consent for participation in the trial Exclusion Criteria: History of accepting lower abdominal surgery. More than one colorectal tumor Patients with unresectable distant metastasis or multiple metastases Received neoadjuvant radiotherapy before surgery Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery Patients and/or family members cannot understand and accept this study Non-rectal adenocarcinoma was confirmed by postoperative pathological examination

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tang Bo, MD

Phone

+862368754167

tangtbo@sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Li Chuan, MD

Phone

+862368754167

79168391@qq.com

Facility Information:

Facility Name

General Surgery Center of PLA

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400038

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tang Bo, M.D/Ph.D

Phone

+862368754167

tangtbo@sina.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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PR in Endoscopic LAR for Rectal Cancer

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