4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / The Effect of Different Reconstruction Methods on Anterior Resection Syndrome (TEDRMARS)

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

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Low Anterior Resection Syndrome Procedure: transverse coloplasty pouch Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Different Reconstruction Methods in Laparoscopic Anterior Rectal Resection on Postoperative Anterior Resection Syndrome：a Randomized Controlled Trial
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : September 1, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: coloplasty(CP)
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
 Procedure: transverse coloplasty pouch
a transverse coloplasty pouch was performed before end to end colon-rectum (or anal canal) anastomosis
No Intervention: straight colorectal anastomosis (SCA)
End to end colon-rectum (or anal canal) anastomosis was performed routinely
Outcome Measures
Primary Outcome Measures :
  1. anterior resection syndrome incidence [ Time Frame: 1 year after surgery ]
    LARS score≥21


Secondary Outcome Measures :
  1. Early postoperative complication incidence [ Time Frame: 30 days after surgery ]
    Anastomotic fistula, Hemorrhage, Pulmonary infection，Death

  2. Length of hospital stay after surgery [ Time Frame: 30 days after surgery ]
    Length of hospital stay

  3. Bowel recovery time [ Time Frame: 7 days after surgery ]
    Time interval from surgery to flatus and defecation

  4. Long-term postoperative complication incidence [ Time Frame: 1 year after surgery ]
    Anastomotic fistula, Hemorrhage，Intestinal obstruction


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Bo Wei, M.D (86)20-85252228 sanpi2013@163.com

Locations
Layout table for location information
China, Guangdong
The Third Affiliated Hospital of Sun Yat-Sen university Recruiting
Guanzhou, Guangdong, China, 510000
Contact: Bo Wei, M.D    (86)20-85252228    sanpi2013@163.com   
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
Layout table for investigator information
Study Director: Hongbo Wei, Ph.D Third Affiliated Hospital, Sun Yat-Sen University
Tracking Information
First Submitted Date  ICMJE July 13, 2019
First Posted Date  ICMJE July 17, 2019
Last Update Posted Date July 17, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019) 		anterior resection syndrome incidence [ Time Frame: 1 year after surgery ]
LARS score≥21
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • Early postoperative complication incidence [ Time Frame: 30 days after surgery ]
    Anastomotic fistula, Hemorrhage, Pulmonary infection，Death
  • Length of hospital stay after surgery [ Time Frame: 30 days after surgery ]
    Length of hospital stay
  • Bowel recovery time [ Time Frame: 7 days after surgery ]
    Time interval from surgery to flatus and defecation
  • Long-term postoperative complication incidence [ Time Frame: 1 year after surgery ]
    Anastomotic fistula, Hemorrhage，Intestinal obstruction
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Different Reconstruction Methods on Anterior Resection Syndrome
Official Title  ICMJE The Effect of Different Reconstruction Methods in Laparoscopic Anterior Rectal Resection on Postoperative Anterior Resection Syndrome：a Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Rectal Cancer
  • Low Anterior Resection Syndrome
Intervention  ICMJE Procedure: transverse coloplasty pouch
a transverse coloplasty pouch was performed before end to end colon-rectum (or anal canal) anastomosis
Study Arms  ICMJE
  • Experimental: coloplasty(CP)
    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
    Intervention: Procedure: transverse coloplasty pouch
  • No Intervention: straight colorectal anastomosis (SCA)
    End to end colon-rectum (or anal canal) anastomosis was performed routinely
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2019) 		138
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2022
Estimated Primary Completion Date May 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bo Wei, M.D (86)20-85252228 sanpi2013@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04023448
Other Study ID Numbers  ICMJE CPSCA-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hongbo Wei, Third Affiliated Hospital, Sun Yat-Sen University
Study Sponsor  ICMJE Third Affiliated Hospital, Sun Yat-Sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hongbo Wei, Ph.D Third Affiliated Hospital, Sun Yat-Sen University
PRS Account Third Affiliated Hospital, Sun Yat-Sen University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯