Abdominal Versus Vaginal Bisection in Laparoscopic Hyster... | NCT04904822

Studies
Abdominal Versus Vaginal Bisection in Laparoscopic Hysterectomy

NCT04904822

Sponsor

Tanta University

Status

Completed

Last Update Posted

Mar 13, 2024Actual

Enrollment

66Actual

Phase

Not Applicable

Conditions

Hysterectomy
Laparoscopy
Uterine Bisection
Large Uteri

Interventions

Vaginal bisection
Abdominal bisection

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

Mar 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

Jun 1, 2021Actual

Primary Completion Date

Oct 31, 2023Actual

Completion Date

Jan 31, 2024Actual

First Submitted Date

May 24, 2021

First Submission Date that Met QC Criteria

May 24, 2021

First Posted Date

May 27, 2021Actual

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

Mar 11, 2024

Last Update Posted Date

Mar 13, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Large uteri present a challenge during Total lap.hysterectomy and its extraction is another challenge. This study addressees and compare 2 methods of retrieval of large uteri

Detailed Description

Despite a number of publications about TLH for large uterus, few surgeons have compared the results of their technique of TLH through the vagina or abdominal bisection. The aim of this study was to compare the clinical results of TLH for large uterus through transvaginal or abdominal bisection approaches after strict preoperative assessment.

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

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	Vaginal bisection of uterus	Procedure: Vaginal bisection
Control group	Experimental	Abdominal bisection	Procedure: Abdominal bisection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vaginal bisection	Procedure	Uterine bisection vaginally by scalpel 24	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrieval time of uterus	Time from end of colpotomy to extraction of uterus	6 months
Blood loss	Amount of blood in suction	6 months

Secondary Outcomes

Measure	Description	Time Frame
Injury of other organs	Number of cases with intraoperative injuries	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

large uterus ≥ 12weeks,
benign pathology,
mobile uterus
BMI less than 30kg/m2

Exclusion Criteria:

unfit for laparoscopy,
Extensive pelvic adhesions,
Extensive endometriosis
malignancy
virgin cases

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University		Tanta	Gharbia Governorate	31111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

we will share results and statistical analysis on valuable request

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

3 months

Access Criteria

Not provided

URL

Not provided