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

The Effect of Different Reconstruction Methods in Laparoscopic Anterior Rectal Resection on Postoperative Anterior Resection Syndrome：a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Low Anterior Resection Syndrome; Rectal Cancer
• Intervention / Treatment: Procedure: transverse coloplasty pouch

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: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guanzhou, Guangdong, China, 510000
      • Recruiting
      • The Third Affiliated Hospital of Sun Yat-Sen University
      • Contact: Bo Wei, M.D; Phone Number: (86)20-85252228; Email: sanpi2013@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anterior resection syndrome incidence	LARS score≥21	1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay after surgery	Length of hospital stay	30 days after surgery
Bowel recovery time	Time interval from surgery to flatus and defecation	7 days after surgery
Early postoperative complication incidence	Anastomotic fistula, Hemorrhage, Pulmonary infection，Death	30 days after surgery
Long-term postoperative complication incidence	Anastomotic fistula, Hemorrhage，Intestinal obstruction	1 year after surgery

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Investigators: Study Director: Hongbo Wei, Ph.D, Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: July 13, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2019
• Last Update Submitted That Met QC Criteria: July 16, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: rectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Syndrome; Rectal Neoplasms
• Other Study ID Numbers: CPSCA-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No