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Surgicel Reduces Ovarian Endometriomas Recurrence

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ClinicalTrials.gov Identifier: NCT02947724
Recruitment Status : Completed
First Posted : October 28, 2016
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Moutaz Sherbini, Cairo University

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.

Condition or disease Intervention/treatment Phase
Endometrioma Drug: SURGICEL® Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Use of Surgicel in Preventing Recurrence of Ovarian Endometriomas During Laparoscopic Surgery
Actual Study Start Date : January 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Arm Intervention/treatment
No Intervention: drainage only
50 patients underwent laparoscopic fenestration and electrocautery of the endometrioma cyst wall
No Intervention: cystectomy only
50 patients underwent laparoscopic excision of the endometrioma cyst wall
Active Comparator: drainage & Surgicel
50 patients underwent laparoscopic fenestration of the endometrioma cyst wall. Insertion of 4 pieces of SURGICEL® inside the cyst cavity
Drug: SURGICEL®
Insertion of 4 pieces of SURGICEL® inside the cyst cavity. Insertion of 4 pieces of SURGICEL® inside the remaining ovarian tissues.

Active Comparator: cystectomy & Surgicel
50 patients underwent laparoscopic excision of the endometrioma cyst wall. Insertion of 4 pieces of SURGICEL® inside the remaining ovarian tissues.
Drug: SURGICEL®
Insertion of 4 pieces of SURGICEL® inside the cyst cavity. Insertion of 4 pieces of SURGICEL® inside the remaining ovarian tissues.




Primary Outcome Measures :
  1. recurrence of endometriomas in the ipsilateral ovary [ Time Frame: 2 YEARS ]
    recurrence was defined as the presence of ovarian cysts with the characteristic sonographic features of endometriomas (≥1 cm)


Secondary Outcome Measures :
  1. biochemical ovarian reserve [ Time Frame: 6 months after laparoscopy ]
    serum antimullerian hormone measuremnt

  2. ultrasonographic ovarian reserve [ Time Frame: 6 months following the operation ]
    antral follicle count on day 2 using transvaginal ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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) .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947724


Locations
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Egypt
Kasr Elainy Hospital (Cairo University)
Cairo, Egypt, 115431
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: moutaz elsherbini, MD Assistant professor of obstetrics and gynecology - Cairo university
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Moutaz Sherbini, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT02947724    
Other Study ID Numbers: 111949
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Keywords provided by Moutaz Sherbini, Cairo University:
chocolate cyst
laparoscopy
surgicel
Additional relevant MeSH terms:
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Endometriosis
Recurrence
Disease Attributes
Pathologic Processes