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Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease

A

Ain Shams University

Status

Completed

Conditions

Benign Gynecological Disease

Treatments

Procedure: LH
Procedure: VH

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full description

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.

Enrollment

80 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria: Women with:

  • 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Group L
Experimental group
Description:
40 patients undergoing laparoscopic hysterectomy
Treatment:
Procedure: LH
Group V
Active Comparator group
Description:
40 patients undergoing vaginal hysterectomy
Treatment:
Procedure: VH

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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