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Surgicel Reduces Ovarian Endometriomas Recurrence

The Use of Surgicel in Preventing Recurrence of Ovarian Endometriomas During Laparoscopic Surgery

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02947724
Enrollment
200
Registered
2016-10-28
Start date
2016-01-31
Completion date
2019-01-31
Last updated
2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrioma

Keywords

chocolate cyst, laparoscopy, surgicel

Brief 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.

Interventions

Insertion of 4 pieces of SURGICEL® inside the cyst cavity. Insertion of 4 pieces of SURGICEL® inside the remaining ovarian tissues.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* 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).

Exclusion criteria

* Recurrent & bilateral cases * Patients who were unfit for surgery, suffered chronic diseases (e.g. cardiac disease or diabetes) * PATIENTS had any contraindication for laparoscopic surgery (excessive anterior abdominal wall scarring) .

Design outcomes

Primary

MeasureTime frameDescription
recurrence of endometriomas in the ipsilateral ovary2 YEARSrecurrence was defined as the presence of ovarian cysts with the characteristic sonographic features of endometriomas (≥1 cm)

Secondary

MeasureTime frameDescription
biochemical ovarian reserve6 months after laparoscopyserum antimullerian hormone measuremnt
ultrasonographic ovarian reserve6 months following the operationantral follicle count on day 2 using transvaginal ultrasound

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026