NCT02947724

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

October 21, 2016

Last Update Submit

April 12, 2019

Conditions

Endometrioma

Keywords

chocolate cystlaparoscopysurgicel

Outcome Measures

Primary Outcomes (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)

    2 YEARS

Secondary Outcomes (2)

  • biochemical ovarian reserve

    6 months after laparoscopy

  • ultrasonographic ovarian reserve

    6 months following the operation

Study Arms (4)

drainage only

NO INTERVENTION

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

cystectomy only

NO INTERVENTION

50 patients underwent laparoscopic excision of the endometrioma cyst wall

drainage & Surgicel

ACTIVE COMPARATOR

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

Drug: SURGICEL®

cystectomy & Surgicel

ACTIVE COMPARATOR

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

Drug: SURGICEL®

Interventions

SURGICEL®DRUG

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

cystectomy & Surgiceldrainage & Surgicel

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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) .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Elainy Hospital (Cairo University)

Cairo, 115431, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 31325962DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Surgicel

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • moutaz elsherbini, MD

    Assistant professor of obstetrics and gynecology - Cairo university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 21, 2016

First Posted

October 28, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

EG(1)