Hemostatic Measures During Laparoscopic Cystectomy for En... | NCT06421857

Studies
Hemostatic Measures During Laparoscopic Cystectomy for Endometrioma

NCT06421857

Sponsor

Ain Shams Maternity Hospital

Status

Completed

Last Update Posted

May 20, 2024Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Endometrioma

Interventions

suturing
bipolar electrocoagulation

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Actual

Primary Completion Date

May 1, 2024Actual

Completion Date

May 1, 2024Actual

First Submitted Date

May 15, 2024

First Submission Date that Met QC Criteria

May 15, 2024

First Posted Date

May 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2024

Last Update Posted Date

May 20, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nagat Hesham Abdelhai Mohammed, postgraduate student, Ain Shams Maternity HospitalPrincipal Investigator

Lead Sponsor

Ain Shams Maternity HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

laparoscopic excision of ovarian endometriotic cysts is generally recommended because it has been associated with a higher spontaneous conception rate, residual ovarian function after the procedure may be affected

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
suturing	Active Comparator	after ovarian cystectomy for endometrioma, separate sutures were applied if there was significant bleeding	Procedure: suturing
bipolar electrocoagulation	Active Comparator	after ovarian cystectomy for endometrioma, the inner wall was coagulated using bipolar electrocoagulation if there was significant bleeding	Procedure: bipolar electrocoagulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
suturing	Procedure	laparoscopic cystectomy for endometrioma and hemostasis was done using suturing	suturing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ovarian reserve	measuring AMH level	6 weeks after procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 35 years
unilateral endometriotic cyst

Exclusion Criteria:

anovulatory women women with decreased ovarian reserve women receiving hormonal treatment three months prior to surgery women with any contraindication to laparoscopy women with previous ovarian surgery possible ovarian malignancy.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Osama Kamel, MD	Ain Shams University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams university		Cairo		11566	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013537	Sutures

Ancestor Terms

ID	Term
D053831	Surgical Fixation Devices
D013523	Surgical Equipment
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided