RecruitingACTRN12611000494932

A study comparing the surgical and patient outcomes with different pre-surgery diet regimes with or without bowel preparation solution for laparoscopic gynaecological surgery

A Single Blind Randomised Controlled Trial of Surgical and Patient Outcomes using Mechanical Bowel Preparation before Laparoscopic Gynaecological Surgery


Sponsor

University of New South Wales

Enrollment

246 participants

Start Date

Nov 24, 2008

Study Type

Interventional

Conditions

Summary

The purpose of this study is to compare the levels of discomfort a patient experiences, to compare the effects on blood components and to compare the surgical outcomes associated with different modes of bowel preparation before gynaecological laparoscopic surgery. Laparoscopic surgery is a minimally invasive surgical technique, for which you have already been admitted to this hospital. Prior to surgery, it is standard procedure in this department for patients to take mechanical bowel preparation. This involves following a diet and then taking a proprietary drink to assist in emptying the bowels. Traditionally, the emptying of the bowels is believed to improve the visualisation of abdominal contents as well as potentially decrease complication rates involving the bowel, though there is not a lot of scientific proof that this is the case. Recent research in gynaecological and bowel surgery has shown that mechanical bowel preparation may not be necessary. In this study, patients will be randomly assigned to one of three groups: 1. Women in group one will only fast (not have anything to eat or drink) before their surgery 2. Women in group two will fast and undertake a minimal residue diet 3. Women in group three will undertake a minimal residue diet and take mechanical bowel preparation as directed. You will have a 33% chance of being in any of the three groups. Neither the doctor nor the study participant can decide which bowel preparation the patient will undertake. This study will be a single blind trial. This means that the doctor will not know which bowel preparation the participant has taken. When you have been assigned to one group, we will provide a detailed outline of the bowel preparation you need to undertake. A study team member will contact you before your surgery to ensure that you know which group you are in and to remind you of the procedures. The knowledge gained from this study will allow us to estimate whether one type of bowel preparation is significantly better for patients, enabling us to provide a better quality of care for all women.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria7

  • Female aged 18 to 80 years
  • Fluent in spoken and written English
  • Capable of completing questions relating to pain
  • Able to understand implications of their involvement in the study
  • Consent to involvement in the study
  • Is a patient of the Department of Endo-Gynaecology, Royal Hospital for Women
  • Consented and scheduled to undergo a gynaecological laparoscopic procedure possibly involving the posterior pelvic compartment requiring mechanical bowel preparation

Exclusion Criteria5

  • May become distressed due to involvement in the study
  • Is currently involved in any other research project
  • Any intercurrent condition that, in the investigator’s opinion, precludes a patient from participating in the study
  • Known or suspected pregnancy
  • Suspected gynaecological malignancy

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Interventions

1. Fasting only group - participants in this group have normal diet until the day before surgery (without fluid restriction) where they fast from midnight the night before surgery (including fluids)

1. Fasting only group - participants in this group have normal diet until the day before surgery (without fluid restriction) where they fast from midnight the night before surgery (including fluids) 2. Minimal residue diet group - 2 days of liquid diet before the surgery; 2 days before surgery - full liquid diet (milk shakes, pumpkin soup, orange juice etc), 1 day before surgery - clear liquod diet (eg apple juice, chicken broth, jelly etc), and fast from midnight the night before if the surgery is in the morning, or from 6am for afternoon surgery (including fluids)


Locations(1)

Australia

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ACTRN12611000494932