Endometrioma Clinical Trial
Official title:
The Use of Surgicel in Preventing Recurrence of Ovarian Endometriomas During Laparoscopic Surgery
Two hundred women aged from 20 to 35 years undergoing conservative laparoscopic treatment of ovarian endometriomas (either by drainage or cyst wall excision) were included. Participants were randomized into 4 groups; group A (drainage only) in which 50 patients underwent laparoscopic fenestration and electrocautery of the endometrioma cyst wall, group B (cystectomy only) in which 50 patients underwent laparoscopic excision of the endometrioma cyst wall, group C (drainage & Surgicel) in which 50 patients underwent laparoscopic fenestration of the endometrioma cyst wall followed by insertion of 4 pieces of Surgicel inside the cyst cavity, group D (cystectomy & Surgicel) in which 50 patients underwent laparoscopic excision of the endometrioma cyst wall followed by insertion of 4 pieces of Surgicel inside the remaining ovarian tissues.All patients were followed up every 3 months for 2 years following the laparoscopic surgery. The primary outcome was the recurrence of endometriomas in the ipsilateral ovary (recurrence was defined as the presence of ovarian cysts with the characteristic sonographic features of endometriomas (≥1 cm). The ovarian reserve was reassessed (AMH & day 2 AFC) as a secondary outcome 6 months following the laparoscopy.
Two hundred women aged from 20 to 35 years undergoing conservative laparoscopic treatment of
ovarian endometriomas (either by drainage or cyst wall excision) were included. Participants
were randomized into 4 groups; group A (drainage only) in which 50 patients underwent
laparoscopic fenestration and electrocautery of the endometrioma cyst wall, group B
(cystectomy only) in which 50 patients underwent laparoscopic excision of the endometrioma
cyst wall, group C (drainage & Surgicel) in which 50 patients underwent laparoscopic
fenestration of the endometrioma cyst wall followed by insertion of 4 pieces of Surgicel
inside the cyst cavity, group D (cystectomy & Surgicel) in which 50 patients underwent
laparoscopic excision of the endometrioma cyst wall followed by insertion of 4 pieces of
Surgicel inside the remaining ovarian tissues. Randomization was done using computer
generated random numbers.
Inclusion criteria included endometriosis-related clinical manifestations (infertility,
pelvic pain or pelvic mass), unilateral & unilocular endometrioma (≥5 cm), rapidly growing
endometrioma & good ovarian reserve (antimullerian hormone {AMH} > 1 ng/ml & antral
follicular count {AFC} > 4). Recurrent & bilateral cases were excluded. In addition, patients
who were unfit for surgery, suffered chronic diseases (e.g. cardiac disease or diabetes) or
had any contraindication for laparoscopic surgery (excessive anterior abdominal wall
scarring) were also excluded.
For all patients, full history was taken followed by complete physical examination &
laboratory investigations (AMH & routine preoperative investigations). Day 2 transvaginal
ultrasound (TVUS) was done using a 7.5 MHz vaginal probe of the General Electric Voluson E8
ultrasound unit (GE Healthcare Austria GmbH, Seoul, Korea) to confirm the presence and assess
the size and side of the endometrioma (ovarian cyst with homogeneous low-level ground glass
echogenicity of the cystic fluid) & to assess the AFC (Number of visible follicles from 2 to
10 mm) in both the affected and healthy ovary.
Cystectomy or drainage was done by one of the investigators. In cystectomy groups (B&D), a
small window (2cm) was done in the cyst wall using diathermy followed by aspiration of the
chocolate material from the cyst then stripping the cyst wall from ovarian tissue using 2
non-traumatic graspers (by traction-counter traction technique) and finally irrigating the
remaining ovarian tissues with normal saline. In drainage groups (A & C), a small window
(2cm) was done in the cyst wall using diathermy followed by aspiration of the chocolate
material from the cyst & then irrigation of the cyst cavity with normal saline. In
non-Surgicel groups (A&B), haemostasis & destruction of the remaining endometriotic cyst wall
was done by bipolar electrocautery. In Surgicel groups (C&D), each SURGICEL® (oxidized
regenerated cellulose - Ethicon US, LLC.) knitted fabric (5 x 10 cm) was divided into four
equal pieces inserted inside the cavity of the cyst (group C) or the remaining ovarian
tissues (group D). If the ovarian edges were gaped, approximation was done using 1-3
interrupted sutures of 4/0 polydioxanone (PDS® Suture - Ethicon US, LLC.). All patients were
followed up every 3 months for 2 years following the laparoscopic surgery. The primary
outcome was the recurrence of endometriomas in the ipsilateral ovary (recurrence was defined
as the presence of ovarian cysts with the characteristic sonographic features of
endometriomas (≥1 cm). The ovarian reserve was reassessed (AMH & day 2 AFC) as a secondary
outcome 6 months following the laparoscopy.
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