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EndometriomaPhase 2NCT02947724

Surgicel Reduces Ovarian Endometriomas Recurrence

A Phase 2 study testing SURGICEL® in people with Endometrioma, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Endometrioma
What is being tested?
SURGICEL®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteEgypt
Study dates
Jan 2016to Jan 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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) .

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Kasr Elainy Hospital (Cairo University)

    Cairo, 115431

Other trials in Egypt

About this study

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.

Read the 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.

Conditions
Endometrioma
Being tested
SURGICEL®
Keywords
chocolate cyst, laparoscopy, surgicel
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SURGICEL®Drug

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

Study groups in NCT02947724
Study groupRoleWhat they receive
drainage onlyNo intervention50 patients underwent laparoscopic fenestration and electrocautery of the endometrioma cyst wall
cystectomy onlyNo intervention50 patients underwent laparoscopic excision of the endometrioma cyst wall
drainage & SurgicelActive comparator50 patients underwent laparoscopic fenestration of the endometrioma cyst wall. Insertion of 4 pieces of SURGICEL® inside the cyst cavity
Receives: Drug: SURGICEL®
cystectomy & SurgicelActive comparator50 patients underwent laparoscopic excision of the endometrioma cyst wall. Insertion of 4 pieces of SURGICEL® inside the remaining ovarian tissues.
Receives: Drug: SURGICEL®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 2 YEARS

Secondary outcomes (2)
  1. biochemical ovarian reserve

    serum antimullerian hormone measuremnt

    Measured: 6 months after laparoscopy

  2. ultrasonographic ovarian reserve

    antral follicle count on day 2 using transvaginal ultrasound

    Measured: 6 months following the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionJan 2019
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02947724
Sponsor's protocol ID
111949
Status last verified
Apr 2019
First submitted
21 Oct 2016
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31325962

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SURGICEL® in people with Endometrioma, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

recurrence of endometriomas in the ipsilateral ovary (time frame: 2 YEARS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02947724, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.

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