Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation

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  • Source

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    Public Title Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation
    Acronym Sorry, not currently available
    Source of Record URL http://clinicaltrials.gov/show/NCT01295138
  • Trial

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    Health Condition(s) or Problem Constipation; Abdominal Pain; Nausea; Vomiting
    Lay Summary Constipation following elective Caesarean sections (CS) is a common problem experienced by up to 50% of patients (1). The causes for this are multifactorial and include manipulation of the bowel during surgery, immobilisation and opiate based anaesthetic and analgesic techniques. To try to alleviate the problem of postoperative constipation, some anaesthetists prescribe postoperative lactulose in addition to postoperative analgesia, although no data exists that shows whether this has any beneficial effect on postoperative constipation. 1. Short term morbidity associated with Caesarean delivery. Hillan EM. Birth. 19 (4): 190-4). (from ClinicalTrials.gov)
    Who can enter the trial Inclusion Criteria: - All patients aged 16 years or older able to give informed consent undergoing their first or second elective CS Exclusion Criteria: - Unable to give informed consent - A basic level of literacy sufficient to complete postoperative form. - History of constipation - Regular opiate use - Previous bowel surgery or bowel adhesions - Lactose intolerant - Diabetic - Any patient unable to have spinal Anaesthesia - Allergies/intolerant to bupivacaine, diamorphine, diclofenac, cocodamol, lactulose - Patients receiving injury to bowel intraoperatively - Patients receiving additional opiates perioperatively
    Who cannot enter the trial Inclusion Criteria: - All patients aged 16 years or older able to give informed consent undergoing their first or second elective CS Exclusion Criteria: - Unable to give informed consent - A basic level of literacy sufficient to complete postoperative form. - History of constipation - Regular opiate use - Previous bowel surgery or bowel adhesions - Lactose intolerant - Diabetic - Any patient unable to have spinal Anaesthesia - Allergies/intolerant to bupivacaine, diamorphine, diclofenac, cocodamol, lactulose - Patients receiving injury to bowel intraoperatively - Patients receiving additional opiates perioperatively
    What will happen Drug; Lactulose; Lactulose liquid. 15mls twice daily; Lactulose group; Lactugal, Rectulose, Lactulose (non proprietry)
    Primary aim Time in hours to passage of first stool post Caesarean Section.
    Secondary Aim Frequency of abdominal pain between lactulose and non-lactulose groups.; First 5 days post Caesarean section.; No; Frequency of abdominal pain between lactulose and non-lactulose groups post Caesarean Section.; Frequency of nausea and vomiting between lactulose and non-lactulose groups; First 5 days post-Caesarean; No; Frequency of nausea and vomiting between lactulose and non-lactulose groups post Caesarean Section.
    Participant Information Sheet Sorry, not currently available
    Website Sorry, not currently available
    Recruitment Status Not Recruiting
    Nation Scotland
    Location Edinburgh
  • Contact

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    Contact for Public Queries Anthony Davis, MBCHB anthonydavis@nhs.net Anthony Davis, MBCHB Principal Investigator NHS Fife
    Contact for Scientific Queries Sorry, not currently available
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