Health Condition 1: null- Patients requiring bowel preparation for gastrointestinal or anorectal surgery
Conditions
Interventions
Intervention1: Na Picosulphate: 10 mg Oral Tablet
Intervention2: sodium Picosulphate: 10 mg oral tablet of sodium picosulphate
Intervention3: Sodium picosulphate: 10mg oral tablet single dose at bedti
Sponsors
VYAS SURGERY
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. Patients having known hypersensitivity to Na Picosulphate or any of the excipients of product (Tablet Cremalax®) 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Difficulty in bowel handlingTimepoint: Day 2 (operative day);Operative field during surgeryTimepoint: Day 2 (operative day);Patient satisfaction for bowel evacuationTimepoint: Day 2 (operative day) | — |
Primary
| Measure | Time frame |
|---|---|
| The efficacy of bowel preparation assessed by the surgeon during the intra-operative period (during surgery) on the basis of a 4-point likert scale.Timepoint: Day 2 (operative day) | — |
Countries
India
Contacts
Public ContactDr Dipak Vyas
VYAS SURGERY
Outcome results
None listed