Clinical trial NCT04023448: The Effect of Different Reconstruction Methods on Anterior Resection Syndrome
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
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Low Anterior Resection Syndrome
Keywords: rectal cancer
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 138
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: anterior resection syndrome incidence
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Early postoperative complication incidence
timeFrame: 30 days after surgery
measure: Length of hospital stay after surgery
timeFrame: 30 days after surgery
measure: Bowel recovery time
timeFrame: 7 days after surgery
measure: Long-term postoperative complication incidence
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-Sen university
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Hongbo Wei, Ph.D
role: STUDY_DIRECTOR
References: