NCT03698604

Brief Summary

The aim of this study is to compare operative time between total laparoscopy hysterectomy with bilateral salpingoophrectomy (TLH+BSO) versus total abdominal hysterectomy and bilateral salpingooophorectomy (TAH+BSO) in women with uterine neoplasia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 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

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

September 26, 2018

Last Update Submit

October 4, 2018

Conditions

HysterectomyLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Operative time

    Operative time measured in minutes using stopwatch excluding time of concomitant surgical procedures.

    From skin incision till closure of the vault "up to 4 hours".

Secondary Outcomes (6)

  • Blood loss

    From skin incision start until skin suturing is finished "up to 4 hours".

  • Blood transfusion

    From admission to the hospital until the home discharge "up to 1 week".

  • Postoperative pain

    8 hours after the end of operation.

  • Hospital stay

    From admission to the hospital until the home discharge "up to 1 week".

  • Incidence of operative complications

    During operation.

  • +1 more secondary outcomes

Study Arms (2)

Total Laparoscopic Hysterectomy

ACTIVE COMPARATOR

The group that will undergo total laparoscopy hysterectomy with bilateral salpingoophrectomy.

Procedure: Hysterectomy

Total Abdominal hysterectomy

ACTIVE COMPARATOR

The group that will undergo total abdominal hysterectomy with bilateral salpingoophrectomy.

Procedure: Hysterectomy

Interventions

HysterectomyPROCEDURE

Total Laparoscopic Hysterectomy Total Abdominal hysterectomy

Total Abdominal hysterectomyTotal Laparoscopic Hysterectomy

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The presence of perimenopausal bleeding
  • Early stage endometrial carcinoma.
  • Endometrial hyperplasia with/without atypia.

You may not qualify if:

  • Obese patients i.e., BMI\< 29 k.g/m2.
  • Patients unfit for laparoscopy as patients with cardio-pulmonary compromise.
  • Presence of adnexal mass.
  • End stage endometrial carcinoma stage 3 \& 4.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

Hysterectomy

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Walid E Mohammed, MD

    Ain Shams Maternity Hospital

    STUDY DIRECTOR

  • Mortada E Ahmed, MD

    Ain Shams Maternity Hospital

    STUDY DIRECTOR

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
Assistant Lecturer

Study Record Dates

First Submitted

September 26, 2018

First Posted

October 9, 2018

Study Start

January 1, 2018

Primary Completion

May 1, 2018

Study Completion

August 1, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

EG(1)