ISRCTN ISRCTN85421386
DOI https://doi.org/10.1186/ISRCTN85421386
Secondary identifying numbers N/A
Submission date
13/04/2011
Registration date
01/06/2011
Last edited
24/05/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Willem Bemelman
Scientific

Academic Medical Centre
Department of Surgery
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Study information

Study designObservational multicentre cross-sectional design
Primary study designObservational
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleIs postoperative first pregnancy rate higher after laparoscopic restorative proctocolectomy than after open restorative proctocolectomy?
Study objectivesAdhesions 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(s)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.
Health condition(s) or problem(s) studiedRestorative proctocolectomy and pregnancy
Intervention1. 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 typeProcedure/Surgery
Primary outcome measureTime (months) to first natural pregnancy after IPAA
Secondary outcome measures1. 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 study start date01/02/2010
Completion date01/04/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participantsA prestudy survey of all 570 IPAAs carried out between 1993 and 2009 in the 3 centres, showed 179 eligible patients.
Key inclusion criteria1. 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
Key exclusion criteria1. Refusal to participate
2. Does not meet inclusion criteria
Date of first enrolment01/02/2010
Date of final enrolment01/04/2011

Locations

Countries of recruitment

  • Belgium
  • Netherlands

Study participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (Netherlands)
Hospital/treatment centre

Department of Surgery
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website http://www.amc.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

University/education

Academic Medical Centre (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article cross sectional study results 01/12/2012 Yes No