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NCT Number: NCT03692832

Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease

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

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Key information

Conditions

Benign Gynecological Disease

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Faculty of Medicine

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LH

Procedure

Laparoscopic hysterectomy following AAGL class IV E, vault closed vaginally

VH

Procedure

Vaginal hysterectomy following Heaney technique

Primary outcomes

  1. Operative time

    Time frame: 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 outcomes

  1. Blood loss

    Time frame: 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)

  2. Blood transfusion

    Time frame: 24 hours post-operative

    Need for blood transfusion

  3. Proportion of successful vaginal opportunistic salpingectomy

    Time frame: intra-operative

    Proportion of patients with successful vaginal opportunistic salpingectomy or salpingo-oophorectomy compared to laparoscopic approach, and factors for non completion

  4. Surgical complications

    Time frame: intra-operative

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

  5. Post-operative pain assessed using visual analogue scale for pain intensity

    Time frame: first 24 hours post-operative

    Post-operative pain: assessed using visual analogue scale for pain intensity at 2, 6 and 24 hours post-operative

  6. Febrile morbidity

    Time frame: first 24 hours post-operative

    Post-operative fever (temperature assessed in degrees Celsius)

  7. Change in serum markers for inflammation

    Time frame: 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)

  8. Hospital-stay

    Time frame: 1 week

    Post-operative hospital-stay (hours)

  9. Healthcare costs

    Time frame: 1 week

    Healthcare costs (EGP), including consumables, medications, and admission fees.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 2, 2018
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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