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ID
Source
Brief title
Health condition
Intraurineadhesions after endometrial ablation
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will investigate the prevalence and describe the severity of IUAs (using a valid scoring system, the American Fertility Society (AFS) classification system) following NovaSure treatment for HMB with NCH gel compared to a NovaSure treatment without the NCH gel. In order to prepare for a future hypothesis testing randomized trial.
Secondary outcome
We will also investigate the complications (like uterus perforation and infection) that can occur during administration of the NCH gel in the uterus. Also, we will investigate dysmenorrhoea/ abdominal pain, PBAC score and menstrual bleeding pattern and patient’s satisfaction between the group of patients following NovaSure treatment with NCH and without the NCH gel.
Background summary
Rationale: Heavy menstrual bleeding (HMB) is a common problem in women of reproductive age. An alternative to hysterectomy in the treatment of HMB is endometrial ablation. Endometrial ablation will destroy the basal layer of the endometrium. Necrosis, degeneration and fibrosis occurs, to alleviate menstrual symptoms. However, destruction of the endometrium and the subsequent inflammatory reaction may result in intrauterine adhesions (IUAs). Given the variability in presentation, the prevalence of IUAs is difficult to estimate precisely. [14]
Postablation IUAs were found up to 52.8%, which may become progressively more sever over time. IUAs can lead to partial or complete closure of the uterine cavity and may cause hematometra, severe cramping pelvic pain and difficulties in accessing the uterine cavity during hysteroscopy. This may result in a possible potential delay in the diagnosis of endometrial carcinoma. [8]
A variety of anti-adhesive gels have been used to protect the endometrium and to prevent IUAs after endometrial ablation. New crosslinked hyaluronan (NCH) gel creates an anti-adhesion barrier to keep the healing tissue separated during the critical repair phase. [7] Different studies have shown a significantly effect of NCH gel in reducing adhesion formation after laparoscopic and hysteroscopic surgery. However, whether this adjuvant therapy with an anti-adhesive gel is effective to prevent the development of IUAs after a NovaSure endometrial ablation remains controversial.
Objective: To evaluate the efficacy of intrauterine application of MateRegen®Gel, a crosslinked hyaluronan gel, in reducing the formation of postoperative IUAs after NovaSure ablation.
Study design: Pilot study of 20 patients.
Study population: Woman with HMB and who are scheduled for NovaSure endometrial ablation are eligible if they agree undergoing a hysteroscopy 6 months after endometrial ablation to assess the uterine cavity.
Intervention: Directly after the NovaSure ablation 10ml MateRegen is inserted in the uterine cavity.
Main study parameters/endpoints: The main study parameters are the number of women with IUAs and severity of the IUAs, objectified during hysteroscopy 6 months after the intervention. Secondary endpoints are complications, pelvic/abdominal pain, patient satisfaction and menstruation bleeding pattern at time of follow-up.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
One extra visit to the hospital is required. A diagnostic hysteroscopy is performed at 6 months. We ask the patients to fill in two short questionnaires at 6 weeks, 3 and 6 months after the NovaSure to assess vaginal bleeding and pelvic pain.
Installation of MateRegen has a potential risk of uterine perforation by the stump inserter, however this has no clinical implications.
Study objective
There are minor intrauterine adhesions after instillation of MateRegen at time of a Novasure ablation in comparison with a Novasure ablation without MateRegen.
Study design
- time of inclusion
- 6 weeks
- 3 months
- 6 months
Intervention
Intrauterine instillation of MateRegen gel after NovaSure treatment.
Inclusion criteria
• Women suffering symptoms from HMB, scheduled for a NovaSure endometrial ablation
• Women in pre-menopausal age
Exclusion criteria
• Women younger than 34
• Women with a desire to preserve fertility
• Women with intracavitary pathology or big intramural myoma seen by transvaginal ultrasound.
• Women with a history of a previous endometrial ablation or curettage
• Women with cervix pathology
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7714 |
| CCMO | NL69032.015.19 |
| OMON | NL-OMON48385 |