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The Effect of Different Reconstruction Methods on Anterior Resection Syndrome (TEDRMARS)

Primary Purpose

Rectal Cancer, Low Anterior Resection Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transverse coloplasty pouch
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rectal Cancer focused on measuring rectal cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 20 years old ≤80 years old, regardless of gender, signed informed consent,
  • BMI≤kg/m^2,
  • Primary rectal lesions are pathologically diagnosed as rectal adenocarcinoma by endoscopic biopsy,
  • The distance between the tumor and the anal margin is 5cm to 12cm,
  • Preoperative tumor stage is T1-4N0-3M0,(according to AJCC-8th TNM tumor staging),
  • Normal anorectal function and LARS score ≤20.

Exclusion Criteria:

  • Patients with inflammatory bowel disease, chronic constipation, irritable bowel syndrome and other intestinal diseases that may affect bowel function,
  • Patients with large tumors or extensive invasion of surrounding tissues and organs, TME is not applicable,
  • Long-term use of drugs (such as morphine) that may affect bowel function,
  • Patients with a history of abdominal, pelvic and anorectal surgery,
  • Patients with severe mental illness or who cannot be evaluated due to cultural or psychological reasons.

Sites / Locations

  • The Third Affiliated Hospital of Sun Yat-Sen universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

coloplasty(CP)

straight colorectal anastomosis (SCA)

Arm Description

After purse-string suture and ligation of the head of the stapler at the colonic end, 5cm away from the colonic end, 5cm longitudinal incision was made to the proximal end of the teniae coli in the anterior wall of the colon, transverse suture was performed, and the plasmomuscular layer was embedded, then end to end colon-rectum (or anal canal) anastomosis was performed

End to end colon-rectum (or anal canal) anastomosis was performed routinely

Outcomes

Primary Outcome Measures

anterior resection syndrome incidence
LARS score≥21

Secondary Outcome Measures

Early postoperative complication incidence
Anastomotic fistula, Hemorrhage, Pulmonary infection,Death
Length of hospital stay after surgery
Length of hospital stay
Bowel recovery time
Time interval from surgery to flatus and defecation
Long-term postoperative complication incidence
Anastomotic fistula, Hemorrhage,Intestinal obstruction

Full Information

First Posted
July 13, 2019
Last Updated
July 16, 2019
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04023448
Brief Title
The Effect of Different Reconstruction Methods on Anterior Resection Syndrome
Acronym
TEDRMARS
Official Title
The Effect of Different Reconstruction Methods in Laparoscopic Anterior Rectal Resection on Postoperative Anterior Resection Syndrome:a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

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

5. Study Description

Brief Summary
The incidence of prerectal resection syndrome (LARS) after middle and low rectal cancer surgery is as high as 70%, which seriously affects the quality of life of patients. Studies have shown that colon pouch can reduce and alleviate LARS symptoms. However, most previous studies focused on open surgery, and the evaluation index lacked objectivity. Therefore, in the context of minimally invasive rectal cancer surgery, it is necessary to re-evaluate the value of improved surgical methods for the prevention of LARS, so as to improve the quality of life of patients.
Detailed Description
The incidence of prerectal resection syndrome (LARS) after middle and low rectal cancer surgery is as high as 70%, which seriously affects the quality of life of patients. LARS may be related to the injury of anal internal sphincter, anal sensory nerve injury, defecation reflex pathway injury, changes in anorectal Angle and rectum sigmoid Angle, changes in new rectal sensory function and compliance, and changes in dynamics,etc. After AR surgery, the rectum loses its good compliance and the storage capacity is reduced, which is one of the important reasons for the increased frequency and urgency of defecation.Therefore, on the basis of traditional colon-rectum (or anal canal) end-to-end anastomosis, "J" shaped pouch anastomosis, end-to-end anastomosis, coloplasty and other special anastomosis methods were performed. Meanwhile, for the lack of objective evaluation index, the results were not credible. The LARS score was first published in 2012,and has been validated, evaluated, or used as an outcome measure in more than 30 published scientific papers. Further more,laparoscopic surgery is widely used in gastrointestinal surgery. Herein, current randomized controlled trial comparing coloplasty with straight colorectal anastomosis in LARS in order to guide clinical practise was conducted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Low Anterior Resection Syndrome
Keywords
rectal cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
coloplasty(CP)
Arm Type
Experimental
Arm Description
After purse-string suture and ligation of the head of the stapler at the colonic end, 5cm away from the colonic end, 5cm longitudinal incision was made to the proximal end of the teniae coli in the anterior wall of the colon, transverse suture was performed, and the plasmomuscular layer was embedded, then end to end colon-rectum (or anal canal) anastomosis was performed
Arm Title
straight colorectal anastomosis (SCA)
Arm Type
No Intervention
Arm Description
End to end colon-rectum (or anal canal) anastomosis was performed routinely
Intervention Type
Procedure
Intervention Name(s)
transverse coloplasty pouch
Intervention Description
a transverse coloplasty pouch was performed before end to end colon-rectum (or anal canal) anastomosis
Primary Outcome Measure Information:
Title
anterior resection syndrome incidence
Description
LARS score≥21
Time Frame
1 year after surgery
Secondary Outcome Measure Information:
Title
Early postoperative complication incidence
Description
Anastomotic fistula, Hemorrhage, Pulmonary infection,Death
Time Frame
30 days after surgery
Title
Length of hospital stay after surgery
Description
Length of hospital stay
Time Frame
30 days after surgery
Title
Bowel recovery time
Description
Time interval from surgery to flatus and defecation
Time Frame
7 days after surgery
Title
Long-term postoperative complication incidence
Description
Anastomotic fistula, Hemorrhage,Intestinal obstruction
Time Frame
1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 20 years old ≤80 years old, regardless of gender, signed informed consent, BMI≤kg/m^2, Primary rectal lesions are pathologically diagnosed as rectal adenocarcinoma by endoscopic biopsy, The distance between the tumor and the anal margin is 5cm to 12cm, Preoperative tumor stage is T1-4N0-3M0,(according to AJCC-8th TNM tumor staging), Normal anorectal function and LARS score ≤20. Exclusion Criteria: Patients with inflammatory bowel disease, chronic constipation, irritable bowel syndrome and other intestinal diseases that may affect bowel function, Patients with large tumors or extensive invasion of surrounding tissues and organs, TME is not applicable, Long-term use of drugs (such as morphine) that may affect bowel function, Patients with a history of abdominal, pelvic and anorectal surgery, Patients with severe mental illness or who cannot be evaluated due to cultural or psychological reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Wei, M.D
Phone
(86)20-85252228
Email
sanpi2013@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongbo Wei, Ph.D
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
Facility Information:
Facility Name
The Third Affiliated Hospital of Sun Yat-Sen university
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Wei, M.D
Phone
(86)20-85252228
Email
sanpi2013@163.com

12. IPD Sharing Statement

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The Effect of Different Reconstruction Methods on Anterior Resection Syndrome

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