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ISRCTN
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ISRCTN85421386
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DOI
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10.1186/ISRCTN85421386
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Female fertility after laparoscopic pouch surgery
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Scientific title
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Is postoperative first pregnancy rate higher after laparoscopic restorative proctocolectomy than after open restorative proctocolectomy?
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Adhesions to the fallopian tubes are thought to be the main cause of infertility after ileal pouch-anal anastomosis (IPAA) surgery, a so-called 'tubal factor infertility'. Recent studies demonstrated a significant decrease in adhesion formation after laparoscopic abdominal surgery. Based on those study results, our hypothesis is that a higher pregnancy rate will be observed after laparoscopic IPAA compared to open IPAA, due to a reduction in adhesions of the Fallopian tubes
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Lay summary
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Not provided at time of registration
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Ethics approval
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The study protocol was approved by the ethics committee of the University Hospitals of the Catholic University in Leuven, Belgium on 30 November 2010, (B32220109939)
In the Netherlands ethics approval is not required for this study design.
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Study design
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Observational multicentre cross-sectional design
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Countries of recruitment
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Belgium, Netherlands
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Disease/condition/study domain
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Restorative proctocolectomy and pregnancy
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Participants - inclusion criteria
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1. All living females who had IPAA between 1993 - 2009
2. IPAA in one of three tertiary referral centres in Belgium and the Netherlands
3. IPAA could be single- or two-stage and laparoscopic or open
4. At the time of IPAA patients had to be under 41 years of age
5. At the time of the study patients had to be 18 years or older
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Participants - exclusion criteria
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1. Refusal to participate
2. Does not meet inclusion criteria
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Anticipated start date
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01/02/2010
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Anticipated end date
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01/04/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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A prestudy survey of all 570 IPAAs carried out between 1993 and 2009 in the 3 centres, showed 179 eligible patients.
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Interventions
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1. All potential participants will be contacted for consent and thereupon a questionnaire will be sent
2. The questionnaire is developed by the departments of Obstetrics and Gynaecology and the department of Surgery at the Academic Medical Centre and it addresses patients’ general medical history and their desire for children both before and after IPAA
3. If patients report that there ever was a desire for children, fertility and obstetric history will be inquired after in detail
4. All self-reported patient data will subsequently be verified and completed by checking the available medical records at the hospital of the IPAA
5. Pregnancy is defined as a ‘clinical pregnancy’ i.e. the presence of a fetus with a heartbeat demonstrated by ultrasound
6. Time to pregnancy is defined as the number of cycles or months between stopping contraceptives until pregnancy occurred, defined as the first day of the last menstrual period
7. Most likely, several patients will report more than one pregnancy, these pregnancies however cannot be considered as independent and therefore only the time to first pregnancy will be used in this study
8. Kaplan-Meier survival curves will be plotted for time to first pregnancy after laparoscopic or open IPAA and will be compared with a log-rank test
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Primary outcome measure(s)
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Time (months) to first natural pregnancy after IPAA
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Secondary outcome measure(s)
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1. Time (months) to any first pregnancy after IPAA, including pregnancies after fertility treatment
2. Subgroup analyses are planned for UC and FAP patients separately, since previous studies have shown different fertility outcomes after IPAA for these groups of patients
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Sources of funding
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Academic Medical Centre (Netherlands)
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Trial website
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Publications
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1. 2012 cross sectional study results in http://www.ncbi.nlm.nih.gov/pubmed/22609840
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Contact name
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Prof
Willem
Bemelman
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Address
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Academic Medical Centre
Department of Surgery
Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Sponsor
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Academic Medical Centre (Netherlands)
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Address
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Department of Surgery
Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Sponsor website:
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http://www.amc.nl/
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Date applied
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13/04/2011
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Last edited
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24/05/2012
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Date ISRCTN assigned
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01/06/2011
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