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

Sun Yat-sen University

Status: Unknown

Conditions: Low Anterior Resection Syndrome; Rectal Cancer

Treatments: Procedure: transverse coloplasty pouch

Study type: Interventional

Funder types: Other

Identifiers

NCT04023448

CPSCA-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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138 participants in 2 patient groups

coloplasty(CP)

Experimental group

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

Treatment:

Procedure: transverse coloplasty pouch

straight colorectal anastomosis (SCA)

No Intervention group

Description:

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