The (Cost-)Effectiveness of Surgical Excision of Colorectal Endometriosis Compared to ART Treatment Trajectory
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21-40
SponsorLeiden University Medical Center
About this trial
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 (PROMs) compared to an IVF/ICSI treatment trajectory.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women in a heterosexual or in a same-sex relationship;
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)
Severe complaints (expectant management is not acceptable (anymore)
Disqualifiers
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);
Trial 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)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Laparoscopic excision of endometriosis, including colorectal endometriosis
Procedure/SurgeryLaparoscopic 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 injection
Procedure/SurgeryIVF/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.
Treatment groups
339 Participants
are divided into 1 treatment groupGroup A: Colorectal endometriosis patients2 interventions
Trial outcomes
Primary outcomes
1
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
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) )Secondary outcomes
1
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.
Time frame
At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery.2
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.
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.3
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.
Time frame
At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery.4
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).
Time frame
At baseline (T=0: when informed consent is granted), 12, 24 and 36 months and in case of surgery, before surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Leiden University Medical Center
Lead sponsor
Haaglanden Medical Centre
Collaborator
University Medical Center Groningen
Collaborator
Maastricht University Medical Center
Collaborator
Radboud University Medical Center
Collaborator
Reinier de Graaf Groep
Collaborator
Catharina Ziekenhuis Eindhoven
Collaborator
UMC Utrecht
Collaborator
Source ClinicalTrials.gov