Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation | Not Recruiting
Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation
Health Conditions
  • Constipation
  • Abdominal Pain
  • Nausea
  • Vomiting
Not Recruiting
Recruitment Status
NCT01295138
Primary Trial ID Number
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).
Primary Outcome Measures
  • Time in hours to passage of first stool post Caesarean Section.; First 5 days post Caesarean section.
Secondary Outcome Measures
  • Frequency of abdominal pain between lactulose and non-lactulose groups.; First 5 days post Caesarean section.; Frequency of nausea and vomiting between lactulose and non-lactulose groups; First 5 days post-Caesarean
Research Question
  • 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).
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Female
Participant Age Range
16 Years to 50 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
30
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
  • 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
Interventions
Drug; Lactulose; Lactulose liquid. 15mls twice daily; [Lactulose group]
Design Details
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Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
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Acronym
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Scientific Title
Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation
Secondary Trial Identifying Number
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Website
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Study Funded By
NHS Fife
Funder Type
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Study Sponsored By
NHS Fife
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

30 Dec 2011

Last Updated

22 Feb 2011

Date Record Refreshed on UKCTG

31 Jul 2015