Assessment of Efficacy, Tolerability and Safety of CremalaxÂ® (Na Picosulphate 10mg) in Bowel Preparation Needed in Patients Undergoing Gastrointestinal OR Ano-rectal Surgery: A Prospective, Non-Comparative Study

VYAS SURGERY0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male or female patients between 18 and 65 years of age
•2. Posted for any GI surgery or ano-rectal Surgery and require bowel preparation as per PI discretion (elective procedure)
•3. Patients willing to sign the written informed consent form
•Willing and able to understand and comply with all study requirements

•1. Patients having known hypersensitivity to Na Picosulphate or any of the excipients of product (Tablet CremalaxÂ®)
•2. Pregnant and lactating women
•3. Patients undergoing emergency surgical procedures
•4. Evidence of structural abnormality of the gastrointestinal tract or diseases/conditions that affect bowel transit
•5. History of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions
•6. Patients with any cardiac, renal, hepatic, neurological disorders, or any chronic illness
•7. Evidence of cathartic colon or history of laxative abuse
•8. Any systemic condition which would call for avoidance/non-use of stimulant laxatives
•9. Any other condition, which in the opinion of the clinician/investigator, could interfere significantly with the treatment and assessment process
•10. Use of any investigational therapy within 30 days prior to randomization
•11. Patients not willing to provide written informed consent

发起方

VYAS SURGERY