Symptomatic niches for laparoscopic niche resection, a randomized clinical trial

The number of caeserean sections is rising, especially in the Western world on
maternal request, without medical necessity. However, 60% of the women who have
had a caeserean section develop a defect at the site of the uterine scar,
called a 'niche'. In 25% of these cases it concerns a large defect with less
that three millimeters of myometrium remaining. This give rise to
gynaecological symptoms such as heavy and/or painful menstrual bleeding,
inter-menstrual uterine blood loss and chronic pain. Hormonal therapy is
available for gynecological complaints, however, in case of failure of or
contraindications to hormonal therapy, surgical intervention can be considered.
Several innovative surgical therapies have been developed to treat
niche-related symptoms, such as a laparoscopic niche resection. This treatment
has been proven effective in the reduction of postmenstrual spotting and
menstrual pain and its implementation in daily practice is increasing
internationally. However, information on the effectiveness of this treatment in
comparison with hormonal therapy in reduction of symptoms for women without a
child wish, has not been studied yet.

Set up an RCT to study whether a laparoscopic niche resection is superior over
hormonal therapy as treatment of niche-related gynaecological complaints for
women with a large symptomatic niche, and without a child wish.

A multicenter randomized clinical trial (RCT) with a control group. The patient
will be randomized to either the intervention group or the control group.
Patients in the intervention group will undergo a laparoscopic niche resection
after approval by the anesthesiologist within 6 weeks. Patients in de control
group receive hormonal therapy, either oral anticonceptives, progesterone, or a
intra-uterine device (IUD) with levenorgestrel. After nine months, if the
provided treatment is not effective enough, patients in both groups are
eligible for additional surgical interventions.

The intervention group will undergo a laparoscopic niche resection. This
procedure is standard care and will be performed by an experience gynaecologist
(> 200 previous laparoscopic niche resections). The resection will be
continuously guided by hysteroscopy. Strong adhesions are often observed
between niche/uterus and the bladder, and/or between niche/uterus and the
abdominal wall. When deemed necessary adhesiolysis is performed and the bladder
is seperated from the proximal uterine wall/niche. Due to the thin myometrium
at the site of niche, the niche can be visualized hysterscopically from within
the uterus. The niche and surrounding fibrotic tissue will be resected. The
uteromie will be closed using at least four sliding knots that include the
complete uterine wall, including the endometrium. A suture is placed over the
closed wound for extra support. In case the uterus is positioned in (extreme)
retroflection, the round ligaments / ligamentum rotundum will be shortened
using two sutures (2,0 multifilament). The niche resection and anatomical
result will be examined by hysteroscopy at the end of the procedure.

Risks and burden are linked to the protocol procedures of a laparoscopic niche
resection. Procedures in the intervention group are carried out by medically
qualified personnel. Laparoscopic niche resection is a safe technique with a
low complication rate reported. The study will only be executed by experienced
gynaecologists with ample experience in executing laparoscopic niche resections
(>200 previous laparoscopic niche resections). Participation is expected to be
beneficial for patients allocated to the Intervention group.