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Endometriosis is a disease that affects between 6 and 10% of women of childbearing age. It is defined by the presence of endometrial tissue outside the uterine cavity, most often in the ovaries or the peritoneal cavity.
The standard treatment for endometriomas is laparoscopic intraperitoneal cystectomy. This treatment has been shown to be associated with a lower rate of recurrence of painful symptoms than simple cyst drainage, and with higher pregnancy rates. Nevertheless, cystectomy can lead to a reduction in ovarian reserve due to the removal of adjacent healthy ovarian tissue, particularly when there is no cleavage plane between the ovary and the endometrioma.
Other methods have been developed to manage endometriomas while preserving the ovarian reserve. Endometrioma sclerotherapy is one of the most promising techniques for reducing the risk of recurrence while preserving the ovarian reserve. This technique involves injecting a sclerosing agent into the cystic cavity, which has been drained beforehand, in order to create an abrasion of the cystic epithelium, resulting in inflammation and fibrosis that can lead to the permanent destruction of the cyst.
The aim of the study is to conduct a single-centre randomised controlled non-inferiority trial comparing sclerotherapy and intraperitoneal cystectomy for the treatment of endometriomas.
The main hypothesis of the study is that sclerotherapy is not inferior to cystectomy in terms of reducing painful symptoms one year after the operation and that it is superior to cystectomy on one or more of the following criteria: preservation of ovarian reserve, operative complications, post-operative pain, patient acceptability/satisfaction.
The number of patients to be included will be 64, calculated to demonstrate non-inferiority between sclerotherapy and cystectomy for the primary endpoint.
Full description
Endometriosis is a disease that affects between 6 and 10% of women of childbearing age. It is defined by the presence of endometrial tissue outside the uterine cavity, most often in the ovaries or the peritoneal cavity. Endometriomas are ovarian cysts whose lining is composed of ectopic endometrium and which contain a liquid resulting from the accumulation of menstrual debris. Between 17% and 44% of women with endometriosis have one or more ovarian endometriomas (i.e. between 1% and 5% of women). The clinical symptoms of endometriomas include pelvic pain (dysmenorrhoea, chronic pelvic pain or dyspareunia) and/or infertility. The standard treatment for endometriomas is laparoscopic intraperitoneal cystectomy. This treatment has been shown to be associated with a lower rate of recurrence of painful symptoms than simple cyst drainage, and with higher pregnancy rates. Nevertheless, cystectomy can lead to a reduction in ovarian reserve due to the removal of adjacent healthy ovarian tissue, particularly when there is no cleavage plane between the ovary and the endometrioma. Excessive coagulation to ensure haemostasis after cystectomy could also contribute to this reduction in ovarian reserve. Other methods have been developed to manage endometriomas while preserving the ovarian reserve: therapeutic abstention, drainage, laser or plasma energy ablation and sclerotherapy. Endometrioma sclerotherapy is one of the most promising techniques for reducing the risk of recurrence while preserving the ovarian reserve. This technique involves injecting a sclerosing agent into the cystic cavity, which has been drained beforehand, in order to create an abrasion of the cystic epithelium, resulting in inflammation and fibrosis that can lead to the permanent destruction of the cyst. This very simple technique is effective and low-risk for treating endometriomas:
Most of what is known about serotherapy comes from non-comparative prospective studies and a few randomised trials comparing sclerotherapy with either no treatment or simple drainage of the endometrioma. In addition, most studies have been conducted in the specific context of endometriomas recurring after cystectomy. To date, there is no comparative trial between sclerotherapy and intraperitoneal cystectomy (reference treatment).
We aim to conduct a single-centre randomised controlled non-inferiority trial comparing sclerotherapy and intraperitoneal cystectomy for the treatment of endometriomas.
The main hypothesis of the study is that sclerotherapy is not inferior to cystectomy in terms of reducing painful symptoms one year after the operation and that it is superior to cystectomy on one or more of the following criteria: preservation of ovarian reserve, operative complications, post-operative pain, patient acceptability/satisfaction.
The main objective is to investigate the non-inferiority of sclerotherapy of endometriomas one year after the operation in terms of reduction of painful symptoms compared with laparoscopic cystectomy. The reduction in painful symptoms was defined by the difference in the number of millimetres of VAS for pain between the preoperative consultation and the consultation one year after the operation, according to the answer to the question : " Indicate the subjective level of your endometriosis-related pain over the last 4 weeks by simply drawing a line through the line".
The secondary objectives were to compare the two techniques:
The number of patients to be included will be 64, calculated to demonstrate non-inferiority between sclerotherapy and cystectomy for the primary endpoint.
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64 participants in 2 patient groups
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Claire MORANDO
Data sourced from clinicaltrials.gov
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