Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease

Not Applicable

Completed

• Conditions: Benign Gynecological Disease
• Interventions: Procedure: LH; Procedure: VH

• Registration Number: NCT03692832
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-30
• Study First Posted: 2018-10-02
• Study Start: 2019-03-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-31
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L	LH	40 patients undergoing laparoscopic hysterectomy
Group V	VH	40 patients undergoing vaginal hysterectomy

Primary Outcome Measures

Name	Time	Method
Operative time	duration of surgical procedure	Total operative time (minutes) for LH versus VH; from introduction of the first laparoscopy port or vaginal incision, till suturing the vaginal vault.

Secondary Outcome Measures

Name	Time	Method
Surgical complications	intra-operative	Surgical complications: visceral or vascular injuries, vaginal cuff haematoma or dehiscence
Post-operative pain assessed using visual analogue scale for pain intensity	first 24 hours post-operative	Post-operative pain: assessed using visual analogue scale for pain intensity at 2, 6 and 24 hours post-operative
Change in serum markers for inflammation	first 24 hours post-operative	Inflammatory response serum markers compared pre- and 24-h postoperatively (e.g. C-reactive protein or interleukin-6 according to availability)
Healthcare costs	1 week	Healthcare costs (EGP), including consumables, medications, and admission fees.
Blood transfusion	24 hours post-operative	Need for blood transfusion
Blood loss	intra-operative	Blood loss (mL): by measuring suctioned blood (subtracting irrigation volumes), Weighing sponges (weight difference of soaked and dry surgical gauzes, 1 g ≃ 1 mL), or according to Gross (1983) formula (mL)
Proportion of successful vaginal opportunistic salpingectomy	intra-operative	Proportion of patients with successful vaginal opportunistic salpingectomy or salpingo-oophorectomy compared to laparoscopic approach, and factors for non completion
Febrile morbidity	first 24 hours post-operative	Post-operative fever (temperature assessed in degrees Celsius)
Hospital-stay	1 week	Post-operative hospital-stay (hours)

Trial Locations

Locations (1)

Ain Shams University Faculty of Medicine; 🇪🇬 Cairo, Egypt