Prevalence of intrauterine adhesions after NovaSure ablation with application of Hyaluronic acid.

Heavy menstrual bleeding (HMB) is a common problem in women of reproductive age
and is one of the most important reasons for consulting a gynaecologist. HMB is
defined as menstrual blood loss exceeding 80mL from normal secretory
endometrium. The incidence varies between 9% and 14%.[1,9,10,11,13] This
disorder may lead to physical consequences as iron deficiency anaemia but is
also associated with effect on the medical, socioeconomic, and psychologic
well-being of women. [3,5,11] Of all hysterectomies, approximately 30-40% are
performed for treatment of severe dysfunctional bleeding. [11,12] Despite the
fact that hysterectomy is a definitive solution for the treatment of
menorrhagia, many women opt a less invasive treatment.
An alternative to hysterectomy in woman with HMB is endometrial ablation.
Endometrial ablation is an established treatment of dysfunctional uterine
bleeding. Many endometrial ablation techniques have been evaluated and
currently have been established as a common daily practise. The NovaSure
endometrial ablation device is one of the second-generation devices that use
bipolar radiofrequency, impedance-controlled endometrial ablation to evaporate
endometrial tissue. Endometrial ablation has proved to be safe and effective in
management of menorrhagia due to benign causes.

Intrauterine adhesions (IUA), represents a gynaecologic disease that leads to
partial or complete closure of the uterine cavity. [14] Intrauterine adhesions
are fibrous intrauterine bands on opposing walls of the uterus. The primary
factors that may trigger intrauterine adhesion formation include curettage
after abortion or postpartum, infections, prolonged retention of an
intrauterine device, operative hysteroscopy or other operations that can injure
the endometrium. [2,14] Approximately 90% of severe intrauterine adhesions are
related to curettage performed because of complications of pregnancy. However,
adhesions can develop in the non-gravid uterus after endometrial injury from
procedures as operative hysteroscopy.[2] As any trauma caused by injury of the
basal lamina of the endometrium can lead to endometrial wall adhesions, a
NovaSure treatment may be accompanied by intrauterine adhesions.
Endometrial ablation will destroy the basal layer of the endometrium down to
the superficial myometrial layer. Necrosis, degeneration, and fibrosis occur,
resulting in alleviation of menstrual symptoms. [8] The endometrium undergoes
necrosis with variable degrees of acute inflammation, followed by a phase of
chronic repair and regeneration with granulomatous reaction. This process
results in most cases in striking endometrial scarring and fibrosis. [6,8]
However, destruction of the endometrium and the inflammatory reaction may
result in formation of intrauterine adhesions. [6,8]
Furthermore, the myometrium that is exposed after ablation and the close
proximity of the anterior and posterior uterine walls raise concerns about
postoperative formation of intrauterine adhesions. Given the variability in
presentation, the prevalence of intrauterine adhesions is difficult to
precisely estimate. [14] Available studies suggest that the uterine cavity had
variable degrees of fibrosis after endometrial ablation.[6,8] In a previous
observational study by Leung et al.[6] postablation intrauterine adhesions were
found in 36.4% after thermal balloon endometrial ablation. Adhesions mostly
involved in the fundal region, but 9% of patients had complete obliteration of
the cavity. The incidence of fibrotic cavity was 18%. [6] Also, Luo et al.
described various types of intrauterine adhesions in 52.8% six months after
microwave endometrial ablation. They concluded that the degree of intrauterine
adhesions may become progressively more severe over time and post-operative
intrauterine adhesions may be a major long-term complication of endometrial
ablation. [4,6] However, the incidence of intrauterine adhesions after NovaSure
endometrium ablation technique has not been fully documented.
Intrauterine adhesions are clinically important. intrauterine adhesions can
lead to partial or complete closure of the uterine cavity. Intrauterine
adhesions that either partially or completely obstruct the isthmus or the
internal uterine ostium may cause hematometra, severe cramping pelvic pain and
difficulties in accessing the uterine cavity during office hysteroscopy. [2] A
potential delay in the diagnosis of endometrial carcinoma is therefore
possible. [6,8]
A variety of antiadhesive gels, which are found to be convenient and safe, have
been used to protect the endometrium and prevent or decrease formation of
intrauterine adhesions. According to Yan et. al. [14] auto-cross-linked
hyaluronic acid (ACP) gel exert a substantial preventive effect against
intrauterine adhesions.[14] In a further randomized controlled trial, Guida et
al. [4] found ACP to be effective in reducing the number and severity of
de-novo- formation of intrauterine adhesions after hysteroscopic surgery. [4]
Recently, a new crosslinked hyaluronan (NCH) gel has been developed to serve as
an absorbable adhesion barrier, which has a much higher viscosity and is
gradually absorbed within 1 to 2 weeks in vivo. [7] The NCH gel creates an
antiadhesion barrier to keep the healing tissue separated during the critical
repair phase. [7] A randomised controlled study by Liu et al. [7],
demonstrates that NCH gel is safe and significantly reduces adnexal adhesion
formation and global adhesion formation throughout the abdominopelvic cavity
after gynaecologic laparoscopic surgery.[7]
However, whether this adjuvant therapy with an antiadhesive gel is effective to
prevent to development of intrauterine adhesions after a NovaSure endometrial
ablation remains controversial.
In this pilot study, we will assess the efficacy of NCH gel in preventing and
decreasing the formation of intrauterine adhesions after endometrial ablation.

To evaluate the efficacy of intrauterine application of MateRegen®Gel, a
crosslinked hyaluronan gel, in reducing the formation of postoperative
intrauterine adhesions after NovaSure ablation.

Pilot study of 20 patients.

Instillation of MateRegen gel after Novasure ablation.

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 to assess bleeding and pain.
Installation of MateRegen has a potential risk of uterine perforation by the
stump inserter, however this has no clinical implications.