The Effect of Different Reconstruction Methods on Anterior Resection Syndrome

Not Applicable

• Conditions: Low Anterior Resection Syndrome; Rectal Cancer
• Interventions: Procedure: transverse coloplasty pouch

• Registration Number: NCT04023448
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

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 Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-13
• Study First Submitted QC: 2019-07-16
• Last Update Submitted: 2019-07-16
• Study First Posted: 2019-07-17
• Last Update Posted: 2019-07-17
• Study Start: 2019-09-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
coloplasty(CP)	transverse coloplasty pouch	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

Primary Outcome Measures

Name	Time	Method
anterior resection syndrome incidence	1 year after surgery	LARS score≥21

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Third Affiliated Hospital of Sun Yat-Sen university; 🇨🇳 Guanzhou, Guangdong, China