The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of return of gastrointestinal function and decrease Post-Operative Ileus in subjects undergoing elective bowel resection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
131
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
General Hospital of Xuzhou Mining Group
Xuzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Time to reach GI-2
• GI-2 is defined as the toleration of solid food and first bowel movement. * Ability to tolerate a solid oral diet is defined as the time from the end of surgery (the time of last skin staple or suture is placed by surgeon) to the time a patient finishes first solid meal that requires chewing and no significant nausea or vomiting for 4 hours after solid meal). * First bowel movement is defined as the time from the end of surgery to the first passage of stool.
Time frame: within 14 days after surgery
Time to reach GI-3
• GI-3 is defined as the toleration of solid food and either first flatus or bowel movement.
Time frame: within 14 days after surgery
Nausea Verbal Rating Scoring Scale
• To assess the nausea and ability to tolerate food
Time frame: within 14 days after surgery
Number of days in the hospital
• Length of Stay (number of days in the hospital, evaluated in hours) will be measured by time to * Discharge order is written, * Actual discharge, and * Standard discharge criteria
Time frame: within 14 days after surgery
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Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Ningbo First Hospital
Ningbo, Zhejiang, China