Surgicel Reduces Ovarian Endometriomas Recurrence
Condition: Endometrioma
MeSH terms: Endometriosis; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): SURGICEL®
Intervention type(s): Drug
Intervention description(s): Insertion of 4 pieces of SURGICEL® inside the cyst cavity. Insertion of 4 pieces of SURGICEL® inside the remaining ovarian tissues.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: chocolate cyst; laparoscopy; surgicel