Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease

Study Overview
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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.

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.

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

Conditions
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Benign Gynecological Disease

Intervention / Treatment
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* Procedure: LH
* Procedure: VH


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |