Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Is postoperative first pregnancy rate higher after laparoscopic restorative proctocolectomy than after open restorative proctocolectomy?
Acronym
Study hypothesis
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
Ethics approval
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.
Study design
Observational multicentre cross-sectional design
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Restorative proctocolectomy and pregnancy
Intervention
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
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Time (months) to first natural pregnancy after IPAA
Secondary outcome measures
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
Overall trial start date
01/02/2010
Overall trial end date
01/04/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
A prestudy survey of all 570 IPAAs carried out between 1993 and 2009 in the 3 centres, showed 179 eligible patients.
Participant exclusion criteria
1. Refusal to participate
2. Does not meet inclusion criteria
Recruitment start date
01/02/2010
Recruitment end date
01/04/2011
Locations
Countries of recruitment
Belgium, Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (Netherlands)
Sponsor details
Department of Surgery
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Academic Medical Centre (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 cross sectional study results in http://www.ncbi.nlm.nih.gov/pubmed/22609840
Publication citations
-
Cross sectional study results
Bartels SA, DʼHoore A, Cuesta MA, Bensdorp AJ, Lucas C, Bemelman WA, Significantly increased pregnancy rates after laparoscopic restorative proctocolectomy: a cross-sectional study., Ann. Surg., 2012, 256, 6, 1045-1048, doi: 10.1097/SLA.0b013e318250caa9.