Laparoscopic Assisted Doderlin Vaginal Hysterectomy | NCT03144414

Studies
Laparoscopic Assisted Doderlin Vaginal Hysterectomy

NCT03144414

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jan 28, 2020Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Laparoscopic Hysterectomy

Interventions

Laparoscopic hysterectomy

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

Jan 2020

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

May 20, 2017Actual

Primary Completion Date

Jan 10, 2020Actual

Completion Date

Jan 20, 2020Actual

First Submitted Date

Apr 30, 2017

First Submission Date that Met QC Criteria

May 5, 2017

First Posted Date

May 8, 2017Actual

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

Jan 26, 2020

Last Update Posted Date

Jan 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This prospective randomized clinical trial will be conducted in Ain Shams University Maternity Hospital during the period from May 2017 to December 2017. Group Ι: 30 patients will undergo conventional laparoscopic assisted vaginal hysterectomy (LAVH). Group ΙΙ: 30 patients will undergo laparoscopic assisted Doderlein vaginal hysterectomy (LADH)

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LAVH	Active Comparator	Laparoscopic Assisted Vaginal Hysterectomy	Procedure: Laparoscopic hysterectomy
LADH	Active Comparator	Laparoscopic Assisted Doderlin Vaginal Hysterectomy	Procedure: Laparoscopic hysterectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic hysterectomy	Procedure	Laparoscopic hysterectomy	LADH LAVH

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operative time		24 hours

Secondary Outcomes

Measure	Description	Time Frame
postoperative pain	questionnaire using Visual Analogue scale	24 hours
operative complications		24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 40 years.
Uterine size ≤ 14weeks.
Benign uterine pathology (Fibroid uterus, endometrial hyperplasia, DUB, uterine prolapse).
No contraindication for laparoscopic surgery.

Exclusion Criteria:

Gynecologic malignancy.
Contraindications to laparoscopy like any medical condition worsened by pneumoperitoneum or the Trendelenburg position.
Large abdominal hernia
Large ovarian mass
History of previous laparotomy finding extensive adhesions

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided