None listed
Conditions
Brief summary
AIM: To determine the impact of mechanical bowel preparation on patient symptomatology and surgical field in deep pelvic gynaecological laparoscopic surgery. HYPOTHESIS: That there is no difference in patient comfort or the surgical field when patients have mechanical bowel preparation by fasting alone, minimal residue diet alone or minimal residue diet with osmotic mechanical bowel preparation prior to advanced laparoscopic gynaecological procedures involving the posterior compartment BACKGROUND: For advanced gynaecological procedures involving the posterior compartment, there is, as yet no evidence to support or refute the use of mechanical bowel preparation, despite its widespread use in clinical practice. Only one study has assessed the impact of mechanical bowel preparation prior to gynaecological laparoscopic surgery, demonstrating increased patient preoperative discomfort with bowel preparation (1) 1. Muzii L, Bellati F, Zullo MA, Manci N, Angioli R, Panici PB. Mechanical bowel preparation before gynecologic laparoscopy: a randomized, single-blind, controlled trial. Fertility and Sterility 2006 Mar;85(3):689-93.
Interventions
Three groups: Fasting alone vs. minimal residue diet alone vs. mechanical bowel preparation and minimal residue diet.
Fasting alone - see comparator/control treatment below
Minimal residue diet - 1 day before surgery: no solid food or milk products to be consumed, clear fluids allowed. On the day of surgery: for morning surgery patients are advised to eat and drink normally up until the day before surgery and to have nothing to eat or drink from midnight (this includes water) and for afternoon
Three groups: Fasting alone vs. minimal residue diet alone vs. mechanical bowel preparation and minimal residue diet. Fasting alone - see comparator/control treatment below Minimal residue diet - 1 day before surgery: no solid food or milk products to be consumed, clear fluids allowed. On the day of surgery: for morning surgery patients are advised to eat and drink normally up until the day before surgery and to have nothing to eat or drink from midnight (this includes water) and for afternoon surgery, no solids are allowed after midnight, but clear fluids such as Gatorade and water are allowed until 6am only. Patients will be advised if they are having morning or afternoon surgery. Full Mechanical Bowel Prep - 2 days before surgery: no solid foods, full liquid diet, milk products allowed. 1 day before surgery: no solid food or milk products to be consumed, clear fluids allowed. One 15.5g sachet of sodium picosulphate (Picoprep) no later than 3pm, and a 2nd sachet 4-6 hours later. Only 2 sachets of osmotic laxative will be used in this study. On the day of surgery: for morning surgery patients are advised to eat and drink normally up until the day before surgery and to have nothing to eat or drink from midnight (this includes water) and for afternoon surgery, no solids are allowed after midnight, but clear fluids such as Gatorade and water are allowed until 6am only. Patients will be advised if they are having morning or afternoon surgery.
Sponsors
Australian Gynaecological Endoscopy Society (AGES)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Consented and scheduled to undergo a gynaecological laparoscopic procedure possibly involving the posterior pelvic compartment (e.g. excision of endometriosis, hysterectomy, posterior pelvic floor repairs and myomectomies are appropriate procedures) requiring mechanical bowel preparation; female aged 18-80; Fluent in spoken and written English; Capable of completing questions relating to patient symptomatology; Consent to involvement in the study
Exclusion criteria
Those who may become distressed due to involvement in the study; those who are 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
Outcome results
None listed