Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease

Benign Gynecological Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692832
• Other study ID #: LH-VH
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: December 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Benign Gynecological Disease

Intervention

Procedure:
• LH
Laparoscopic hysterectomy following AAGL class IV E, vault closed vaginally
• VH
Vaginal hysterectomy following Heaney technique

Locations

Country	Name	City	State
Egypt	Ain Shams University Faculty of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Blood transfusion	Need for blood transfusion	24 hours post-operative
Secondary	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
Secondary	Surgical complications	Surgical complications: visceral or vascular injuries, vaginal cuff haematoma or dehiscence	intra-operative
Secondary	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
Secondary	Febrile morbidity	Post-operative fever (temperature assessed in degrees Celsius)	first 24 hours post-operative
Secondary	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
Secondary	Hospital-stay	Post-operative hospital-stay (hours)	1 week
Secondary	Healthcare costs	Healthcare costs (EGP), including consumables, medications, and admission fees.	1 week