Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-03-01

Brief Summary

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

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Detailed Description

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The current trial evaluates the performance and short-term postoperative outcomes of these two approaches for hysterectomy in Ain Shams University Maternity Hospital, a major tertiary hospital in Greater Cairo, and one of Egypt's leading centers in terms of provision of public medical service.

Eighty patients with benign indications, with no contraindications to neither laparoscopic nor vaginal approaches, were randomized into two equal groups, to undergo either of the two procedures: LH or VH.

Conditions

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Benign Gynecological Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group L

40 patients undergoing laparoscopic hysterectomy

Group Type EXPERIMENTAL

LH

Intervention Type PROCEDURE

Laparoscopic hysterectomy following AAGL class IV E, vault closed vaginally

Group V

40 patients undergoing vaginal hysterectomy

Group Type ACTIVE_COMPARATOR

VH

Intervention Type PROCEDURE

Vaginal hysterectomy following Heaney technique

Interventions

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LH

Laparoscopic hysterectomy following AAGL class IV E, vault closed vaginally

Intervention Type PROCEDURE

VH

Vaginal hysterectomy following Heaney technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No