ClinicalTrials.gg
CompletedNCT03370952Updated Jan 11, 2022

Laparoscopy-assisted Ovarian Cystectomy: NEW APPROCH

An interventional study of laproscopy and combined laproscopic and minilaparotomy ovarian cystectomy in Ovarian Cysts, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Non-randomized
Ages
20 Years to 35 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Ovarian Cysts with a site in Egypt — 2 open to participants now, 2 under way, none of them phase 3. Ovarian Cysts · Egypt.

Started
2017
with 1 other
No phase
8 of 10
2 open now
Registered
2nd of 10
by date
Lead sponsor
1 of 10
Cairo University

Among the 10 studies in Ovarian Cysts with a site in Egypt, this one is one of 2 that started in 2017, is one of 8 with no phase, and was the 2nd registered.

Ovarian Cysts

80 studies on the registry are indexed under Ovarian Cysts; 16 are open to participants now.

Browse Ovarian Cysts studies →

Open to participants now

2 of the 10 studies in Ovarian Cysts with a site in Egypt are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 12 Ovarian Cysts studies recruiting now, 4 (33%) set no upper age limit and 7 (58%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.

This study: 20 Years to 35 Years · female · no healthy volunteers.

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02

Study summary

Under general anaesthesia, the patient is placed in the modified dorsal lithotomy position a 10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with full assessment of the ovarian mass(es).

Aspiration of the cyst:

Veress needle is inserted in the midline 2 cm above the symphysis pubis to aspirate the cyst under laparoscopic guidance (to guide the entry of the needle into the cyst wall \& to confirm complete aspiration).

Delivery of affected ovary outside the abdominal cavity:

Classic ovarian cystectomy will be done using microsurgical techniques in which the cyst wall will be dissected gently and carefully from the healthy ovarian tissue followed by perfect haemostasis and re-fashioning of the remaining ovarian tissue using Vicryl (3-0) sutures.

Re-introduction of the ovary to inside the abdominal cavity:

The stitched ovary is pushed gently inside the abdominal cavity and the mini-laparotomy is re-covered by the rubber shield (to allow re-inflation of the abdominal cavity). The ovary is reassessed under laparoscopic guidance to ensure perfect haemostasis and normal position of the ovary. Pelvic irrigation is done if needed.

Read the detailed description

Patient positioning and port placement:

Under general anaesthesia, the patient is placed in themodified dorsal lithotomy position (to ensure lax anterior abdominal wall). The patient is thenprepped and draped in the usual fashion for an abdominaland vaginal procedure. In non- virgin patients, vaginal speculum is inserted into thevagina to expose the cervix, a uterine manipulator is inserted in the cervix followed by placement of a Foley's catheter in thebladder. As regards port placement, a 10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with full assessment of the ovarian mass(es).

Aspiration of the cyst:

Veress needle is inserted in the midline 2 cm above the symphysis pubis to aspirate the cyst under laparoscopic guidance (to guide the entry of the needle into the cyst wall \& to confirm complete aspiration).

Delivery of affected ovary outside the abdominal cavity:

A transverse mini-laparotomy is done (2-3 cm) in the midline 2 cm above the symphysis pubis. A long shanks artery forceps is introduced inside the abdominal cavity (to grasp the affected ovary) under laparoscopic guidance. Then, the artery is pulled gently to the outside to deliver the ovary at the mini-laparotomy skin incision. Careful handling and traction is applied to avoid injury of both the ovarian tissue or/andinfundibulopelvic ligament. Following the delivery of the ovary, the abdominal incision is temporary closed using (E-shaped 10 x 10 cm) rubbershield (to avoid any soiling of abdominal cavity with blood or cystic fluid \& give the chance to reinflate the abdominal cavity later on).

Ovarian cystectomy:

Classic ovarian cystectomy will be done using microsurgical techniques in which the cyst wall will be dissected gently and carefully from the healthy ovarian tissue followed by perfect haemostasis and re-fashioning of the remaining ovarian tissue using Vicryl (3-0) sutures.

Re-introduction of the ovary to inside the abdominal cavity:

The stitched ovary is pushed gently inside the abdominal cavity and the mini-laparotomy is re-covered by the rubber shield (to allow re-inflation of the abdominal cavity). The ovary is reassessed under laparoscopic guidance to ensure perfect haemostasis and normal position of the ovary. Pelvic irrigation is done if needed.

03

Conditions studied

  • Ovarian Cysts

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04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • unilateral or bilateral ovarian cysts (≥ 10 cm),
  • recurrent ovarian cysts
  • good ovarian reserve (antimullerian hormone {AMH} > 1 ng/ml \& antral follicular count {AFC} > 4)

Exclusion criteria

Exclusion Criteria:

  • solid ovarian masses
  • patients who were unfit for surgery
  • chronic diseases (e.g. cardiac disease or diabetes)
  • any for laparoscopic surgery (excessive anterior abdominal wall scarring)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
112 participants (actual)

Study arms

  • Active comparator
    new approach

    Under general anaesthesia, the patient is placed in the modified dorsal lithotomy position a 10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with full assessment of the ovarian mass(es). Aspiration of the cyst: Delivery of affected ovary outside the abdominal cavity: A transverse mini-laparotomy is done (2-3 cm) in the midline 2 cm above the symphysis pubis. Ovarian cystectomy: Re-introduction of the ovary to inside the abdominal cavity:

    Procedure: combined laproscopic and minilaparotomy ovarian cystectomy

  • Active comparator
    Laproscopic ovarian cystectomy

    classic laparoscopic ovarian cystectomy

    Procedure: laproscopy

Interventions

  • Procedurelaproscopy

    laparoscopic ovarian cystectomy

  • Procedurecombined laproscopic and minilaparotomy ovarian cystectomy

    Under general anaesthesia, the patient is placed in the modified dorsal lithotomy position a 10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with full assessment of the ovarian mass(es). Aspiration of the cyst:Delivery of affected ovary outside the abdominal cavity: Ovarian cystectomy: Re-introduction of the ovary to inside the abdominal cavity:

06

What researchers measure

Primary outcomes

  1. recurrence of ovarian masses

    recurrence was defined as the presence of ovarian cysts ≥2 cm in the ipsilateral ovary

    Time frame: 6 months after the operation

Secondary outcomes

  1. serum follicle stimulating hormone

    Measurement of FSH on 2nd day of a natural cycle as a marker of ovarian reserve

    Time frame: 6 months after the operation

  2. Serum antimullerian hormone

    Measurement of AMH on 2nd day of a natural cycle as a marker of ovarian reserve

    Time frame: 6 months after the operation

07

Study locations

1 site
  • Kasr Alainy medical school
    Cairo, 12151, Egypt
08

References and documents

Publications

  • Shaltout MF, Maged AM, Abdella R, Sediek MM, Dahab S, Elsherbini MM, Elkomy RO, Zaki SS. Laparoscopic guided minilaparotomy: a modified technique for management of benign large ovarian cysts. BMC Womens Health. 2022 Jul 4;22(1):269. doi: 10.1186/s12905-022-01853-4. PubMed 35787807 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in Jul 2019, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2017
First posted
Dec 13, 2017
StartActual
Dec 21, 2017
Primary completionActual
Jul 5, 2019
CompletionActual
Aug 3, 2019
Last update
Jan 11, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03370952
Lead sponsor
Cairo University
Responsible party
Ahmed M Maged, MD (professor, Cairo University) — Principal investigator
First posted
Dec 13, 2017
Start date
Dec 21, 2017
Primary completion
Jul 5, 2019
Completion
Aug 3, 2019
Last update
Jan 11, 2022

Study contacts

Ahmed Maged, MD
study director · Professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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