NCT03370952

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

December 21, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2019

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

1.5 years

First QC Date

December 5, 2017

Last Update Submit

January 8, 2022

Conditions

Ovarian Cysts

Outcome Measures

Primary Outcomes (1)

  • recurrence of ovarian masses

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

    6 months after the operation

Secondary Outcomes (2)

  • serum follicle stimulating hormone

    6 months after the operation

  • Serum antimullerian hormone

    6 months after the operation

Study Arms (2)

new approach

ACTIVE COMPARATOR

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

Laproscopic ovarian cystectomy

ACTIVE COMPARATOR

classic laparoscopic ovarian cystectomy

Procedure: laproscopy

Interventions

laproscopyPROCEDURE

laparoscopic ovarian cystectomy

Laproscopic ovarian cystectomy
combined laproscopic and minilaparotomy ovarian cystectomyPROCEDURE

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:

new approach

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 35787807DERIVED

MeSH Terms

Conditions

Ovarian Cysts

Condition Hierarchy (Ancestors)

CystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Ahmed Maged, MD

    Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 5, 2017

First Posted

December 13, 2017

Study Start

December 21, 2017

Primary Completion

July 5, 2019

Study Completion

August 3, 2019

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

EG(1)