Assessment of Efficacy, Tolerability and Safety of Sodium Picosulphate (Cremalax®) in Bowel Preparation Needed in Patients Undergoing Gastrointestinal or Ano-Rectal Surgery: A Prospective, Non-Comparative Study
Journal Title: New Indian Journal of Surgery - Year 2017, Vol 8, Issue 4
Abstract
Context: Mechanical bowel preparation (MBP) is a medical process involving evacuation of bowels with the use of laxatives before surgery involving the colon and ano-rectum to cleanse the bowels. MBP is shown to reduce the rates of infectious postoperative complications. Sodium picosulphate is a stimulant laxative commonly used orally for bowel preparation before gastrointestinal (GI)or anorectal surgery. There is scarcity of Indian data on role of sodium picosulphate in bowel preparation needed in patients undergoing gastrointestinal and anorectal surgery. Aims: To evaluate the efficacy, tolerability, safety of sodium picosulphate in bowel preparation needed in patients undergoing GI or ano-rectal surgery. Settings and Design: Prospective, non-comparative interventional study. Methods and Material: 100 patients (55 males and 45 females) between 18 to 65 years of age and posted for GI or ano-Rectal surgery who requires bowel preparation as per PI discretion (elective procedure) and willing to sign the written informed consent form are enrolled in this study. These patients were prescribed 2 tablets of Sodium Picosulphate 10 mg at night before the procedure. The efficacy outcomes were the efficacy of bowel preparation assessed by the surgeon intraoperatively on a 4-point likert scale of 1 = poor (large solid stool), 2 = satisfactory (particulate formed stools), 3 = good (fluid and gas filled), and 4 = excellent (colon/ano-rectum empty and collapsed); clean operative field, difficulty in bowel handling during surgery, and patient satisfaction for bowel evacuation assessed on a scale of 0 = not satisfied at all, 1 = somewhat satisfied, and 2 = completely satisfied. The tolerability and safety was assessed based on the adverse events reported and the symptoms of nausea, vomiting, abdominal pain/cramps, bloating and weakness assessed on a 0-10 visual analogue scale (VAS). Statistical Analysis Used: Descriptive statistics are presented for the study outcomes. Results: Of the 100 patients enrolled the study (median age of 44.22 years) 54 were males and 45 were females. 44 patients underwent GI surgery while 55 patients underwent anorectal surgery. Efficacy of Bowel preparation (in perprotocol dataset, N=99) as assessed by surgeon intraoperatively was rated as Excellent in 40.41%, Good in 48.48%, Satisfactory in 10.1%, and Poor in 1.01% patients. Operative field as assessed by surgeon during the procedure as “clean” in 98% patients. Difficulty in handling the bowel was reported as “no” in 99% patients. Bowel evacuation satisfaction as assessed by patients was rated as ‘Completely satisfied’ by 73.74%, ‘somewhat satisfied’ by 25.25% were and ‘not satisfied’ by 1.01% patients. Therapy with sodium picosulphate was well tolerated, mild intensity adverse events of weakness, bloating, abdominal cramps, nausea and vomiting were reported by few patients. Conclusions: Sodium picosulphate can be considered as a good therapeutic armamentarium to surgeons for its use in bowel preparation needed in patients posted for GI or anorectal surgeries and further studies can be considered to substantiate these findings.
Authors and Affiliations
Vyas Dipak
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- EP ID EP473033
- DOI 10.21088/nijs.0976.4747.8417.8
- Views 85
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