Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease

Laparoscopic Versus Vaginal Hysterectomy for Benign Gynaecological Disease in Ain Shams University Maternity Hospital: A Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Benign Gynecological Disease
• Intervention / Treatment: Procedure: LH; Procedure: VH

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Faculty Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group L; 40 patients undergoing laparoscopic hysterectomy	Procedure: LH; Laparoscopic hysterectomy following AAGL class IV E, vault closed vaginally
Active Comparator: Group V; 40 patients undergoing vaginal hysterectomy	Procedure: VH; Vaginal hysterectomy following Heaney technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	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)	intra-operative
Blood transfusion	Need for blood transfusion	24 hours post-operative
Proportion of successful vaginal opportunistic salpingectomy	Proportion of patients with successful vaginal opportunistic salpingectomy or salpingo-oophorectomy compared to laparoscopic approach, and factors for non completion	intra-operative
Surgical complications	Surgical complications: visceral or vascular injuries, vaginal cuff haematoma or dehiscence	intra-operative
Post-operative pain assessed using visual analogue scale for pain intensity	Post-operative pain: assessed using visual analogue scale for pain intensity at 2, 6 and 24 hours post-operative	first 24 hours post-operative
Febrile morbidity	Post-operative fever (temperature assessed in degrees Celsius)	first 24 hours post-operative
Change in serum markers for inflammation	Inflammatory response serum markers compared pre- and 24-h postoperatively (e.g. C-reactive protein or interleukin-6 according to availability)	first 24 hours post-operative
Hospital-stay	Post-operative hospital-stay (hours)	1 week
Healthcare costs	Healthcare costs (EGP), including consumables, medications, and admission fees.	1 week

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 30, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 31, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: LH-VH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No