NCT03251677

Brief Summary

The objective of this study is to compare the perioperative outcomes between mini-lap hysterectomy and total laparoscopic hysterectomy (TLH) because of benign indications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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

August 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

August 10, 2017

Last Update Submit

September 27, 2019

Conditions

Hysteromyoma

Outcome Measures

Primary Outcomes (2)

  • Operative Time (min)

    Time in minutes taken for total hysterectomy

    Intraoperative (Starting with induction of anesthesia (Time 0) up to complete removal of the uterus)

  • Estimated blood loss (mL)

    Drop of hemoglobin and hematocrit percentage (%) 24-hours from basal pre-operative values

    Through surgical intervention completion

Secondary Outcomes (1)

  • Early postoperative complications

    Within 30 days after operation

Study Arms (2)

Total laparo hysterectomy

ACTIVE COMPARATOR

Surgical procedure, Hysterectomy (removal of the uterus by laparoscopy)

Procedure: Surgical procedure, Hysterectomy

Mini-lap hysterectomy

ACTIVE COMPARATOR

Surgical procedure, Hysterectomy (removal of the uterus by mini-laparotomy)

Procedure: Surgical procedure, Hysterectomy

Interventions

Surgical procedure, HysterectomyPROCEDURE

Surgical removal of the uterus

Mini-lap hysterectomyTotal laparo hysterectomy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mobile uterus.
  • Uterine size up to 12 weeks gestation.
  • Benign lesions.

You may not qualify if:

  • Enlarged uterus \> 12 weeks gestation.
  • Suspected malignancy.
  • Large adnexal masses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarek Shokeir

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Interventions

Surgical Procedures, OperativeHysterectomy

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Tarek Shokeir

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Obstetrics & Gynecology

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 16, 2017

Study Start

September 1, 2017

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

Sharing up to scientific publication of a manuscript

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Up to scientific publication of a manuscript
Access Criteria
Personal
More information

Locations

EG(1)