Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease

Ain Shams University80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Benign Gynecological Disease

Interventions

LHPROCEDURE

Laparoscopic hysterectomy following AAGL class IV E, vault closed vaginally

VHPROCEDURE

Vaginal hysterectomy following Heaney technique

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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)

Locations (1)

Ain Shams University Faculty of Medicine

Cairo, Egypt

Outcomes

Primary Outcomes

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.

Time frame: duration of surgical procedure

Secondary Outcomes

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)

Time frame: intra-operative

Blood transfusion

Need for blood transfusion

Time frame: 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

Time frame: intra-operative

Surgical complications

Surgical complications: visceral or vascular injuries, vaginal cuff haematoma or dehiscence

Time frame: 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

Time frame: first 24 hours post-operative

Febrile morbidity

Post-operative fever (temperature assessed in degrees Celsius)

Time frame: first 24 hours post-operative

Data from ClinicalTrials.gov

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