Other Clinical Trial - The (Cost-)Effectiveness of Surgical Excision of

Status Recruiting

Clinical 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 (PROMs) compared to an IVF/ICSI treatment trajectory.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05677269
Study type	Observational [Patient Registry]
Source	Leiden University Medical Center
Contact	Mathijs D. Blikkendaal, MD,PhD
Phone	088 979 44 89
Email	M.Blikkendaal@rdgg.nl
Status	Recruiting
Phase
Start date	February 17, 2023
Completion date	January 1, 2029

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04171297` - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Withdrawn	`NCT03481842` - Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis	Phase 1/Phase 2
Recruiting	`NCT03532074` - Indocyanine Green and Rectosigmoid Endometriosis	N/A
Completed	`NCT03138954` - Endoscopic Rectal UltraSound With Elastosonography and Contrast in Deep Pelvic Endometriosis With Bowel Involvement
Completed	`NCT04411004` - Persistence Disease After Laparoscopic Shaving of Rectal Endometriosis
Completed	`NCT04338035` - Fertility in Untreated Rectosigmoid Endometriosis
Active, not recruiting	`NCT01291576` - Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum	N/A
Completed	`NCT04295343` - Three-dimensional (3D) Rectal Water Contrast Transvaginal Ultrasonography Versus Computed Colonography in the Diagnosis of Rectosigmoid Endometriosis
Recruiting	`NCT04398641` - Surgery for Lower Rectum Deep Endometriosis (Segmental/Disc) - Prospective Comparison of Digestive Symptoms and Pain
Active, not recruiting	`NCT04339946` - Bidimensional Rectal-water Contrast-transvaginal Ultrasonography (2D-RWC-TVS) Versus 3D-RWC-TVS in the Diagnosis of Rectosigmoid Endometriosis
Completed	`NCT04406155` - Bowel Preparation Before 3D Rectal Water Contrast Transvaginal Ultrasonography for Rectosigmoid Endometriosis
Completed	`NCT04296760` - Rectal Water-contrast Transvaginal Ultrasonography Versus Sonovaginography for the Diagnosis of Posterior Deep Pelvic Endometriosis
Recruiting	`NCT04891003` - The Identification of Optimal Ultrasonografic Tecniques for Determining the Location , Size and the Surgical Methods of Intestinal Endometriotric Nodules
Active, not recruiting	`NCT04204707` - Patient Reported Outcomes After Surgery for Rectal Endometriosis
Completed	`NCT04494568` - Evaluation of High Intensity Focused Ultrasound (HIFU) in the Treatment of Rectal Endometriosis	N/A
Not yet recruiting	`NCT04491305` - EHP-5 in Preoperative Assessment in Women With Endometriosis

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms