Endometriosis, RectumTOSCANCT05677269

The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory

An observational study of Endometriosis, Rectum and Endometriosis of Colon, run by Leiden University Medical Center at 10 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

To goal of this study is to determine whether laparoscopic resection of colorectal endometriosis results in an increased cumulative live birth rate (CLBR) both spontaneous and after ART (including in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), and better patient reported outcome measures… Read more about this study

Who is it for?: Ages 21 to 40 years, women only
Conditions the study is for: Endometriosis, Rectum, Endometriosis of Colon, Subfertility, Female
What is being tested?: Laparoscopic excision of endometriosis, including colorectal endometriosis and In vitro fertilisation or intracytoplasmic sperm injection
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
How many people: 339 participants
Where: 10 sitesNetherlands
Study dates: 17 Feb 2023to 1 Jan 2029
How long will I take part?: 40 Months
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 40 years
Women only
Adult

Study population: Subfertile women between 21 and 40 years with colorectal endometriosis facing the choice (at the start of their treatment trajectory or after one or two unsuccessful IVF/ICSI cycles) between IVF/ICSI or laparoscopic excision of (colorectal) endometriosis to increase the chance to conceive (naturally)

Who may be able to join

Colorectal endometriosis defined as endometriosis involving the (colo)rectum:
#Enzian classification score C1,C2,C3 (C=rectum) or FI (F=far locations, I=sigmoid colon) detected with ultrasound or MRI;
Women in a heterosexual or in a same-sex relationship;
The patient has an active wish to conceive and experiences at least one of the following criteria:
At least one year of non-conception (either spontaneous of after intra uterine inseminations)
Inability to have timed intercourse because of pain (dyspareunia and/or chronic pelvic pain)

Show all 14Show fewer

Severe complaints (expectant management is not acceptable (anymore)
The patients has an indication for IVF/ICSI according to Dutch guidelines (Werkgroep netwerkrichtlijn, december 2010);
failed intra uterine insemination
male factor subfertility (oligoasthenoteratozoospermia defined as VCM <1 million)
bilateral tubal pathology (e.g. bilateral hydrosalpinx, bilateral tubal occlusion)
age > 38 years and (unexplained) subfertility
severe endometriosis in case of subfertility
The patient is faces the choice between IVF/ICSI or laparoscopic (colorectal) endometriosis or is on the waiting list for a respective treatment at T=0 (at the beginning of the treatment trajectory), T=1 (after one unsuccessful IVF/ICSI cycle) or T=2 (after 2 unsuccessful IVF/ICSI cycles)

Who cannot join

Patients with deep endometriosis without colorectal involvement;
Patients who conceive spontaneously prior to intervention;
Patients requiring surgery on short notice and therefore unable to opt for IVF/ICSI (e.g. in case of unilateral or bilateral hydronephrosis, severe bowel stenosis and suspicion of an impending ileus);
Patients with a contra-indication for IVF/ICSI (e.g. diminished ovarian reserve (premature ovarian failure) (AMH (when available) <p10 adjusted for age), untreated congenital uterine abnormalities, maltreated/untreated systemic or malignant disease or severe risk factors for oocyte aspiration);
Patients diagnosed with other diseases causing infertility (e.g. recurrent miscarriages, antiphospholipid syndrome);
Not able to read and understand Dutch or English.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mathijs D. Blikkendaal, MD,PhD contact

088 979 44 89

M.Blikkendaal@rdgg.nl

Rozemarijn de Koning, MD contact

r.de_koning@lumc.nl

City, postcode or hospital

Sites recruiting now only

10 sites in 1 country

Netherlands10 sites, 10 recruiting

Catharina Ziekenhuis
Eindhoven
Dana Huppelschoten
Recruiting
Medical Spectrum Twente
Enschede
Marieke Verberg
Recruiting
University Medical Center Groningen
Groningen
Astrid Cantineau
Recruiting
Leiden University Medical Center
Leiden
Dries Twijnstra
Recruiting
Maastricht University Medical Center
Maastricht
Jacques Maas
Recruiting
Radboud university medical center
Nijmegen
Annemiek Nap
Recruiting
Erasmus Medical Centre
Rotterdam
Yvonne Louwers
Recruiting
Haaglanden Medical Center
The Hague
Moniek van der Zanden
Recruiting
Utrecht Medical Center
Utrecht
Simone Broer
Recruiting
Nederlandse Endometriose Kliniek (Reinier de Graaf Gasthuis)
Voorburg
Tobias Limperg
Recruiting

Other trials in Netherlands

About this study

Read the detailed description

Endometriosis is characterized by extra-uterine endometrium like tissue and affects 10-15% of the women in their reproductive years and in 5-12% of these women colorectal endometriosis is present. The quality of life is lowered due to severe pain symptoms (dysmenorrhea, dyschezia, dysuria, chronic pelvic pain) and subfertility.The management of colorectal endometriosis-related subfertility is challenging. While the impact of colorectal endometriosis per se remains inconclusive as other intraperitoneal endometriosis lesions are frequently present, fertility is most likely affected by multiple mechanisms including inflammatory alterations in peritoneal fluid, alterations in estrogen and progesterone hormone levels, lowered endometrium receptivity, associated adenomyosis, a lower ovarian reserve (in case endometriomas are present) and adhesion formation that disrupts adnexal anatomy and function. Usually, surgery is preferred in case of dominant pain complaints, while IVF/ICSI is started when the wish to conceive is dominant. Recent evidence suggests a CLBR of 44.9% in patients with rectosigmoid endometriosis treated by surgery compared to 55.9% after 4 cycles of IVF/ICSI treatment without surgery. In the Netherlands, the number of reimbursed IV/ICSI attempts in limited to three. In addition, a combined strategy may result in even higher cumulative live birth rates. However, the place and optimal timing of surgery in patients with colorectal endometriosis and a desire to have children is unknown.

To provide robust evidence that can be extrapolated to the Dutch healthcare system, this study aims to determine whether surgical excision of colorectal endometriosis results in increased CLBR both spontaneous and after IVF/ICSI, and better PROMs compared to an IVF/ICSI treatment trajectory.

Conditions: Endometriosis, Rectum, Endometriosis of Colon, Subfertility, Female
Being tested: Laparoscopic excision of endometriosis, including colorectal endometriosis, In vitro fertilisation or intracytoplasmic sperm injection
Keywords: Colorectal endometriosis, Subfertility, Surgery, In vitro fertilisation, Live birth rate, Quality of life, Cost-effectiveness
Medical subject headings: Endometriosis, Infertility, Female, Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laparoscopic excision of endometriosis, including colorectal endometriosisProcedure or surgery
Laparoscopic resection of deep endometriosis, including colorectal endometriosis, in a (candidate) level 2 centre of expertise. Complete resection can exist of either 'shaving' of the nodule from the bowel (leaving the lumen closed), discoid excision or segmental resection, depending on the nodule size and extent of disease.
In vitro fertilisation or intracytoplasmic sperm injectionProcedure or surgery
IVF/ICSI treatment trajectory (maximum of 3 cycles), according to the local protocol. Preferably preceded by 3 months downregulation with either Gonadotrophin-releasing hormone (GnRH) analogue or oral contraceptive pill. One IVF/ICSI cycle is defined as the transfer of all the embryos created after one follicle puncture until pregnancy confirmation or failure of the last embryo transfer.

Study groups in NCT05677269
Study group	Role	What they receive
Colorectal endometriosis patients		Subfertile women between 21 and 40 years with colorectal endometriosis facing the choice between IVF/ICSI or laparoscopic resection of (colorectal) endometriosis. Receives: Procedure: Laparoscopic excision of endometriosis, including colorectal endometriosis; Procedure: In vitro fertilisation or intracytoplasmic sperm injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative live birth rate
Live birth is defined as the complete expulsion or extraction from a women of a product of fertilization, after 20 weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut of the placenta is attached. A birth weight of 350 grams or more can be used if gestational age is unknown
Measured: At the end of the study period (live birth or after 3 IVF/ICSI attempts and/or surgery in the follow-up period (40 months) )

Secondary outcomes (7)

Endometriosis specific symptoms
Endometriosis Health Profile-30 (EHP-30). The overall EHP-30 score ranges from 0 to 100, with a high score indicating poorer health-related quality of life.
Measured: At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery.
Quality of life in general
EuroQql five-dimensional 5 levels (EQ-5D-5L) and EuroQql Visual Analog Scale (EQ-VAS).
According to the Dutch scoring algorithm, the EQ-5D-5L score index value ranges from -0.446 (55555 worst health state) to 1 (11111, best health state).
Overall health will be represented by the EQ-VAS, ranging from 0 to 100, with higher scores indicating better health.
Measured: At baseline (T=0: when informed consent is granted), 6, 12, 18, 24, 30, 36 and 40 months and in case of surgery, before surgery.
Bowel specific symptoms
Lower Anterior Resection Syndrome score (LARS score). The total LARS score ranges from 0, indicating no LARS to 42 points, indicating major LARS.
Measured: At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery.
Pain scores
NRS score for dysmenorrhea, dysuria, dyschezia, dyspareunia and chronic pelvic pain. The NRS scale ranges from 0 (no pain) to 10 (worst pain imaginable).
Measured: At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery.
Productivity costs
Productivity costs questionnaire: institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ).
Productivity costs will be measured by calculating absence from paid work (absenteeism), reduced productivity at paid work (presenteeism), and productivity loss in unpaid work. Hours of productivity loss will be translated by a standard cost price of productivity per hour.
Measured: At baseline (T=6, 12, 18, 24, 30, 36 and 40 months and in case of surgery, before surgery.
Medical costs per group
Costs surgery, costs IVF/ICSI treatment, costs extra hospital admissions / emergency room visits / visits outpatient care
Measured: At the end of the study period (live birth or after 3 IVF/ICSI attempts and/or surgery in the follow-up period (40 months) )
Complications
Intraoperative and postoperative complications, IVF/ICSI associated complications, pregnancy complications
Measured: At the end of the study period (live birth or after 3 IVF/ICSI attempts and/or surgery in the follow-up period (40 months) )

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 20231 Jan 2029

First posted10 Jan 2023
Study start17 Feb 2023
Primary completionJul 2028 (estimated)
Study completion1 Jan 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Endometriosis, RectumStudies of the same condition, open and under way.
More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 339 participants (estimated)
Target duration: 40 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT05677269
Sponsor's protocol ID: N22.085
Acronym: TOSCA
Status last verified: Nov 2024
First submitted: 9 Dec 2022
Last updated: 21 Nov 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

F Barra, C Scala, S Bogliolo, N Di Donato, M Ceccaroni, S Ferrero, O-309 Surgery versus IVF/ICSI in infertile women with rectosigmoid endometriosis: the FERTILITY-RECTOSIGMOID study, Human Reproduction, Volume 37, Issue Supplement_1, July 2022

Interested in taking part?

Mathijs D. Blikkendaal, MD,PhD

088 979 44 89

M.Blikkendaal@rdgg.nl

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Endometriosis, Rectum trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
ClinicalTrials.gov ID: NCT05677269
Acronym / sponsor ID: TOSCA / N22.085
Conditions: Endometriosis, Rectum, Endometriosis of Colon, Subfertility, Female
Keywords: Colorectal endometriosis, Subfertility, Surgery, In vitro fertilisation, Live birth rate, Quality of life, Cost-effectiveness
Study type: Observational
Recruitment status: Recruiting
Enrolment: 339 participants (estimated)
Lead sponsor: Leiden University Medical CenterUniversity, hospital or other
Collaborators: Haaglanden Medical Centre, University Medical Center Groningen, Maastricht University Medical Center, Radboud University Medical Center, Reinier de Graaf Groep, Catharina Ziekenhuis Eindhoven, UMC Utrecht
Study start: 17 Feb 2023 (actual)
Primary completion: Jul 2028 (estimated)
Study completion: 1 Jan 2029 (estimated)
First posted: 10 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 40 Months
Number of arms: 1

Arm	Type	Receives
Colorectal endometriosis patients	–	Procedure: Laparoscopic excision of endometriosis, including colorectal endometriosis, Procedure: In vitro fertilisation or intracytoplasmic sperm injectionSubfertile women between 21 and 40 years with colorectal endometriosis facing the choice between IVF/ICSI or laparoscopic resection of (colorectal) endometriosis.

Who may qualify

Ages: 21 to 40 years
Sex: Female only
Age groups: Adult
Study population: Subfertile women between 21 and 40 years with colorectal endometriosis facing the choice (at the start of their treatment trajectory or after one or two unsuccessful IVF/ICSI cycles) between IVF/ICSI or laparoscopic excision of (colorectal) endometriosis to increase the chance to conceive (naturally)

Key inclusion criteria (14 listed)

Colorectal endometriosis defined as endometriosis involving the (colo)rectum:
#Enzian classification score C1,C2,C3 (C=rectum) or FI (F=far locations, I=sigmoid colon) detected with ultrasound or MRI;
Women in a heterosexual or in a same-sex relationship;
The patient has an active wish to conceive and experiences at least one of the following criteria:
The patients has an indication for IVF/ICSI according to Dutch guidelines (Werkgroep netwerkrichtlijn, december 2010);

Key exclusion criteria (6 listed)

Patients with deep endometriosis without colorectal involvement;
Patients who conceive spontaneously prior to intervention;
Patients requiring surgery on short notice and therefore unable to opt for IVF/ICSI (e.g. in case of unilateral or bilateral hydronephrosis, severe bowel stenosis and suspicion of an impending ileus);
Patients with a contra-indication for IVF/ICSI (e.g. diminished ovarian reserve (premature ovarian failure) (AMH (when available) <p10 adjusted for age), untreated congenital uterine abnormalities, maltreated/untreated systemic or malignant disease or severe risk factors for oocyte aspiration);
Patients diagnosed with other diseases causing infertility (e.g. recurrent miscarriages, antiphospholipid syndrome);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Laparoscopic excision of endometriosis, including colorectal endometriosisLaparoscopic resection of deep endometriosis, including colorectal endometriosis, in a (candidate) level 2 centre of expertise. Complete resection can exist of either 'shaving' of the nodule from the bowel (leaving the lumen closed), discoid excision or segmental resection, depending on the nodule size and extent of disease.	Procedure or surgery	Colorectal endometriosis patients
In vitro fertilisation or intracytoplasmic sperm injectionIVF/ICSI treatment trajectory (maximum of 3 cycles), according to the local protocol. Preferably preceded by 3 months downregulation with either Gonadotrophin-releasing hormone (GnRH) analogue or oral contraceptive pill. One IVF/ICSI cycle is defined as the transfer of all the embryos created after one follicle puncture until pregnancy confirmation or failure of the last embryo transfer.	Procedure or surgery	Colorectal endometriosis patients

Primary outcome

Cumulative live birth rate
Time frame: At the end of the study period (live birth or after 3 IVF/ICSI attempts and/or surgery in the follow-up period (40 months) )
Live birth is defined as the complete expulsion or extraction from a women of a product of fertilization, after 20 weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut of the placenta is attached. A birth weight of 350 grams or more can be used if gestational age is unknown

7 secondary outcomes

Endometriosis specific symptoms
Time frame: At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery.
Quality of life in general
Time frame: At baseline (T=0: when informed consent is granted), 6, 12, 18, 24, 30, 36 and 40 months and in case of surgery, before surgery.
Bowel specific symptoms
Time frame: At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery.
Pain scores
Time frame: At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery.
Productivity costs
Time frame: At baseline (T=6, 12, 18, 24, 30, 36 and 40 months and in case of surgery, before surgery.
Medical costs per group
Time frame: At the end of the study period (live birth or after 3 IVF/ICSI attempts and/or surgery in the follow-up period (40 months) )
Complications
Time frame: At the end of the study period (live birth or after 3 IVF/ICSI attempts and/or surgery in the follow-up period (40 months) )

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
Results publicationF Barra, C Scala, S Bogliolo, N Di Donato, M Ceccaroni, S Ferrero, O-309 Surgery versus IVF/ICSI in infertile women with rectosigmoid endometriosis: the FERTILITY-RECTOSIGMOID study, Human Reproduction, Volume 37, Issue Supplement_1, July 2022
Individual participant dataSharing planned: No

Related trials for Endometriosis, Rectum

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Mathijs D. Blikkendaal, MD,PhD contact

088 979 44 89

M.Blikkendaal@rdgg.nl

Rozemarijn de Koning, MD contact

r.de_koning@lumc.nl

Mathijs D. Blikkendaal, MD, PhD principal investigator

Nederlandse Endometriose Kliniek (NEK), Reinier de Graaf Gasthuis

Andries RH Twijnstra, MD, PhD study chair

Leiden University Medical Center

Astrid EP Cantineau, MD, PhD study chair

University Medical Center Groningen

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis, Rectum and Endometriosis of Colon, run by Leiden University Medical Center at 10 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mathijs D. Blikkendaal, MD,PhD (088 979 44 89, M.Blikkendaal@rdgg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative live birth rate (time frame: At the end of the study period (live birth or after 3 IVF/ICSI attempts and/or surgery in the follow-up period (40 months) )). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05677269, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.