Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Willem Bemelman

ORCID ID

Contact details

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

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 measures

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

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

http://www.amc.nl/

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

Results - basic reporting

Publication summary

1. 2012 cross sectional study results in http://www.ncbi.nlm.nih.gov/pubmed/22609840

Publication citations

  1. 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.

Editorial Notes