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

benign gynaecological pathology requiring laparoscopic surgery

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

Plain Language Summary

Simplified for easier understanding

This study is comparing three different ways to prepare the bowel before laparoscopic (keyhole) gynaecological surgery. Currently, many hospitals use a full bowel preparation (a special drink that empties the bowel). But research in other types of surgery suggests this may not always be necessary. This trial will randomly assign women to one of three groups: fasting only, fasting plus a minimal residue diet, or a minimal residue diet plus full bowel preparation — to find out which causes the least discomfort and gives the best surgical outcomes. You may be eligible if: - You are a woman between 18 and 80 years old - You speak and read English fluently - You are scheduled for a gynaecological laparoscopic procedure at the Royal Hospital for Women that may involve the posterior pelvic area You may NOT be eligible if: - You are currently participating in another research study - You are known or suspected to be pregnant - You have a suspected gynaecological cancer - You have any other condition that, in the researcher's opinion, makes it unsafe to participate Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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