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Laparoscopy-assisted Ovarian Cystectomy: NEW APPROCH

Primary Purpose

Ovarian Cysts

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laproscopy
combined laproscopic and minilaparotomy ovarian cystectomy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cysts

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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:

  • solid ovarian masses
  • patients who were unfit for surgery
  • chronic diseases (e.g. cardiac disease or diabetes)
  • any contraindication for laparoscopic surgery (excessive anterior abdominal wall scarring)

Sites / Locations

  • Kasr Alainy medical school

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

new approach

Laproscopic ovarian cystectomy

Arm Description

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:

classic laparoscopic ovarian cystectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

serum follicle stimulating hormone
Measurement of FSH on 2nd day of a natural cycle as a marker of ovarian reserve
Serum antimullerian hormone
Measurement of AMH on 2nd day of a natural cycle as a marker of ovarian reserve

Full Information

First Posted
December 5, 2017
Last Updated
January 8, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03370952
Brief Title
Laparoscopy-assisted Ovarian Cystectomy: NEW APPROCH
Official Title
Laparoscopy-assisted Ovarian Cystectomy: NEW APPROCH
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
July 5, 2019 (Actual)
Study Completion Date
August 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cysts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
new approach
Arm Type
Active Comparator
Arm Description
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:
Arm Title
Laproscopic ovarian cystectomy
Arm Type
Active Comparator
Arm Description
classic laparoscopic ovarian cystectomy
Intervention Type
Procedure
Intervention Name(s)
laproscopy
Intervention Description
laparoscopic ovarian cystectomy
Intervention Type
Procedure
Intervention Name(s)
combined laproscopic and minilaparotomy ovarian cystectomy
Intervention Description
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:
Primary Outcome Measure Information:
Title
recurrence of ovarian masses
Description
recurrence was defined as the presence of ovarian cysts ≥2 cm in the ipsilateral ovary
Time Frame
6 months after the operation
Secondary Outcome Measure Information:
Title
serum follicle stimulating hormone
Description
Measurement of FSH on 2nd day of a natural cycle as a marker of ovarian reserve
Time Frame
6 months after the operation
Title
Serum antimullerian hormone
Description
Measurement of AMH on 2nd day of a natural cycle as a marker of ovarian reserve
Time Frame
6 months after the operation

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: solid ovarian masses patients who were unfit for surgery chronic diseases (e.g. cardiac disease or diabetes) any contraindication for laparoscopic surgery (excessive anterior abdominal wall scarring)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
Professor
Official's Role
Study Director
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35787807
Citation
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.
Results Reference
derived

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Laparoscopy-assisted Ovarian Cystectomy: NEW APPROCH

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