NCT03692832

Brief Summary

This study is designed to compare laparoscopic and vaginal hysterectomy in women with benign gynaecological disease in Ain Shams University Maternity Hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

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

September 10, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 14, 2022

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

September 10, 2018

Last Update Submit

December 31, 2021

Conditions

Benign Gynecological Disease

Outcome Measures

Primary Outcomes (1)

  • Operative time

    Total operative time (minutes) for LH versus VH; from introduction of the first laparoscopy port or vaginal incision, till suturing the vaginal vault.

    duration of surgical procedure

Secondary Outcomes (9)

  • Blood loss

    intra-operative

  • Blood transfusion

    24 hours post-operative

  • Proportion of successful vaginal opportunistic salpingectomy

    intra-operative

  • Surgical complications

    intra-operative

  • Post-operative pain assessed using visual analogue scale for pain intensity

    first 24 hours post-operative

  • +4 more secondary outcomes

Study Arms (2)

Group L

EXPERIMENTAL

40 patients undergoing laparoscopic hysterectomy

Procedure: LH

Group V

ACTIVE COMPARATOR

40 patients undergoing vaginal hysterectomy

Procedure: VH

Interventions

LHPROCEDURE

Laparoscopic hysterectomy following AAGL class IV E, vault closed vaginally

Group L
VHPROCEDURE

Vaginal hysterectomy following Heaney technique

Group V

Eligibility Criteria

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

You may qualify if:

  • Women undergoing hysterectomy for benign gynaecological disease (e.g., dysfunctional uterine bleeding, adenomyosis, fibroids).

You may not qualify if:

  • known tubo-ovarian pathology requiring primary laparotomy, e.g. large adnexal masses
  • known neoplasia requiring pelvic lymphadenectomy
  • pelvic organ prolapse requiring additional procedures, e.g., uterine procidentia (complete prolapse), enterocoele
  • conditions interfering with laparoscopic surgery, e.g. cardio-pulmonary disease, obesity (BMI 30 kg/m2 or more)
  • large uteri interfering with vaginal hysterectomy (size \>16 gestational weeks)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Faculty of Medicine

Cairo, Egypt

Location

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 10, 2018

First Posted

October 2, 2018

Study Start

March 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

January 14, 2022

Record last verified: 2021-12

Locations

EG(1)