Study of Efficacy, Safety and Tolerability of Na-Picosulphate in patients requiring anorectal surgery

Phase 4

Completed

• Conditions: Health Condition 1: null- Patients requiring bowel preparation for gastrointestinal or anorectal surgery

• Registration Number: CTRI/2016/09/007292
• Lead Sponsor: VYAS SURGERY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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)