Surgicel Reduces Ovarian Endometriomas Recurrence
Primary Purpose
Endometrioma
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
SURGICEL®
Sponsored by
About this trial
This is an interventional prevention trial for Endometrioma focused on measuring chocolate cyst, laparoscopy, surgicel
Eligibility 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) .
Sites / Locations
- Kasr Elainy Hospital (Cairo University)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
No Intervention
Active Comparator
Active Comparator
Arm Label
drainage only
cystectomy only
drainage & Surgicel
cystectomy & Surgicel
Arm Description
50 patients underwent laparoscopic fenestration and electrocautery of the endometrioma cyst wall
50 patients underwent laparoscopic excision of the endometrioma cyst wall
50 patients underwent laparoscopic fenestration of the endometrioma cyst wall. Insertion of 4 pieces of SURGICEL® inside the cyst cavity
50 patients underwent laparoscopic excision of the endometrioma cyst wall. Insertion of 4 pieces of SURGICEL® inside the remaining ovarian tissues.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
biochemical ovarian reserve
serum antimullerian hormone measuremnt
ultrasonographic ovarian reserve
antral follicle count on day 2 using transvaginal ultrasound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02947724
Brief Title
Surgicel Reduces Ovarian Endometriomas Recurrence
Official Title
The Use of Surgicel in Preventing Recurrence of Ovarian Endometriomas During Laparoscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrioma
Keywords
chocolate cyst, laparoscopy, surgicel
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
drainage only
Arm Type
No Intervention
Arm Description
50 patients underwent laparoscopic fenestration and electrocautery of the endometrioma cyst wall
Arm Title
cystectomy only
Arm Type
No Intervention
Arm Description
50 patients underwent laparoscopic excision of the endometrioma cyst wall
Arm Title
drainage & Surgicel
Arm Type
Active Comparator
Arm Description
50 patients underwent laparoscopic fenestration of the endometrioma cyst wall. Insertion of 4 pieces of SURGICEL® inside the cyst cavity
Arm Title
cystectomy & Surgicel
Arm Type
Active Comparator
Arm Description
50 patients underwent laparoscopic excision of the endometrioma cyst wall. Insertion of 4 pieces of SURGICEL® inside the remaining ovarian tissues.
Intervention Type
Drug
Intervention Name(s)
SURGICEL®
Intervention Description
Insertion of 4 pieces of SURGICEL® inside the cyst cavity. Insertion of 4 pieces of SURGICEL® inside the remaining ovarian tissues.
Primary Outcome Measure Information:
Title
recurrence of endometriomas in the ipsilateral ovary
Description
recurrence was defined as the presence of ovarian cysts with the characteristic sonographic features of endometriomas (≥1 cm)
Time Frame
2 YEARS
Secondary Outcome Measure Information:
Title
biochemical ovarian reserve
Description
serum antimullerian hormone measuremnt
Time Frame
6 months after laparoscopy
Title
ultrasonographic ovarian reserve
Description
antral follicle count on day 2 using transvaginal ultrasound
Time Frame
6 months following the operation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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) .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
moutaz elsherbini, MD
Organizational Affiliation
Assistant professor of obstetrics and gynecology - Cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Elainy Hospital (Cairo University)
City
Cairo
ZIP/Postal Code
115431
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
31325962
Citation
Shaltout MF, Elsheikhah A, Maged AM, Elsherbini MM, Zaki SS, Dahab S, Elkomy RO. A randomized controlled trial of a new technique for laparoscopic management of ovarian endometriosis preventing recurrence and keeping ovarian reserve. J Ovarian Res. 2019 Jul 20;12(1):66. doi: 10.1186/s13048-019-0542-0.
Results Reference
derived
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Surgicel Reduces Ovarian Endometriomas Recurrence
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