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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group L | Experimental | 40 patients undergoing laparoscopic hysterectomy |
|
| Group V | Active Comparator | 40 patients undergoing vaginal hysterectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LH | Procedure | Laparoscopic hysterectomy following AAGL class IV E, vault closed vaginally |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria: Women with:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Faculty of Medicine | Cairo | Egypt |
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| VH |
| Procedure |
Vaginal hysterectomy following Heaney technique |
|
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 |