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

Not Applicable

Recruiting

• Conditions: benign gynaecological pathology requiring laparoscopic surgery; Surgery - Other surgery

• Registration Number: ACTRN12611000494932
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 246

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
surgical visual field and bowel handling[at the time of surgery, using Visual analogue scale (VAS)and Verbal descriptor scale (VDS)]

Secondary Outcome Measures

Name	Time	Method
change in patient symptomatology, using VAS and VDS on the symptoms of headache, nausea & vomiting, thirst, weakness, tiredness and overall level of discomfort[baseline (at the time of recruitment for the study- anytime before 2 days prior to surgery)<br>On the day of surgery, prior to the procedure<br>1 day after surgery];change in patient's bowel function, using a validated questionnaire (colorectal functional outcome questionnaire, as well as Hallbook & Vaizey questionnaire[basesline (time of recruitment of study)<br>1 week after surgery<br>1 month after surgery];change in patient's electrolyte and haematocrit, using meaurement of patient's serum EUC & FBC level from blood sample[baseline (time of recruitment of study)<br>on the day of surgery, prior to the procedure]