NCT04904822

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

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

May 24, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

2.4 years

First QC Date

May 24, 2021

Last Update Submit

March 11, 2024

Conditions

HysterectomyLaparoscopyUterine BisectionLarge Uteri

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Injury of other organs

    6 months

Study Arms (2)

Study group

EXPERIMENTAL

Vaginal bisection of uterus

Procedure: Vaginal bisection

Control group

EXPERIMENTAL

Abdominal bisection

Procedure: Abdominal bisection

Interventions

Vaginal bisectionPROCEDURE

Uterine bisection vaginally by scalpel 24

Study group
Abdominal bisectionPROCEDURE

Uterine bisection by endokinfe

Control group

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 31111, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Closed envelopes containing allocations
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups parallel allocation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 24, 2021

First Posted

May 27, 2021

Study Start

June 1, 2021

Primary Completion

October 31, 2023

Study Completion

January 31, 2024

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

we will share results and statistical analysis on valuable request

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
3 months

Locations

EG(1)