Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Hamdy Bakry Alqenawy，Ain Shams University

Tracking Information

First Submitted Date ^ICMJE

September 10, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

October 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Procedure: LH
Laparoscopic hysterectomy (TLH or LHa)
Procedure: VH
Vaginal hysterectomy

Study Arms

Experimental: Group L
Active Comparator: Group V

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2020

Estimated Primary Completion Date

October 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Sex/Gender

Sexes Eligible for Study:

Female

Ages

N/A and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Hamdy Bakry Alqenawy，Ain Shams University

Study Sponsor ^ICMJE

Ain Shams University

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Ain Shams University

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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