Surgicel Reduces Ovarian Endometriomas Recurrence

NCT ID: NCT02947724

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-01-31

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.

Conditions

Endometrioma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

drainage only

50 patients underwent laparoscopic fenestration and electrocautery of the endometrioma cyst wall

Group Type: NO_INTERVENTION

No interventions assigned to this group

cystectomy only

50 patients underwent laparoscopic excision of the endometrioma cyst wall

Group Type: NO_INTERVENTION

No interventions assigned to this group

drainage & Surgicel

50 patients underwent laparoscopic fenestration of the endometrioma cyst wall. Insertion of 4 pieces of SURGICEL® inside the cyst cavity

Group Type: ACTIVE_COMPARATOR

SURGICEL®

Intervention Type: DRUG

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

cystectomy & Surgicel

50 patients underwent laparoscopic excision of the endometrioma cyst wall. Insertion of 4 pieces of SURGICEL® inside the remaining ovarian tissues.

Group Type: ACTIVE_COMPARATOR

SURGICEL®

Intervention Type: DRUG

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

Interventions

SURGICEL®

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

Intervention Type: DRUG

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) .

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Moutaz Sherbini

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

moutaz elsherbini, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor of obstetrics and gynecology - Cairo university

Locations

Kasr Elainy Hospital (Cairo University)

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 31325962 (View on PubMed)

Other Identifiers

111949

Identifier Type: -

Identifier Source: org_study_id