Laparoscopic Versus Vaginal Hysterectomy in Women With Abnormal Uterine Bleeding Using Bipolar Vessel Sealer

NCT04237558 | Completed

• 1 other identifier: AM1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a randomized clinical trial to evaluate the surgical performance and outcome of total laparoscopic hysterectomy compared to non-descent vaginal hysterectomy ,using bipolar vessel sealer,in cases of abnormal uterine bleeding in Mansoura University Hospital in order to reach the optimum technique for our locality

Conditions

Uterine Bleeding

Keywords

Vaginal hysterectomy; Laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (1)

• Duration of operation

  Duration of operation

  From start of surgery up to 24 hours

Secondary Outcomes (2)

• Time of requiring analgesics

  Until 24 hours postoperatively

• Number of requiring analgesics

  Until 24 hours postoperatively

Study Arms (2)

Vaginal hysterectomy

ACTIVE COMPARATOR

Removal of uterus through vagina in absence of prolapse

Procedure: Vaginal hysterectomy

Laparoscopic hysterectomy

ACTIVE COMPARATOR

Key hole surgery through small incisions of the abdomen

Procedure: Laparoscopic hysterectomy

Interventions

Vaginal hysterectomy PROCEDURE

Vaginal hysterectomy by removal of uterus through vagina in absence of prolapse

Vaginal hysterectomy

Laparoscopic hysterectomy PROCEDURE

Laparoscopic hysterectomy through key hole surgery through small incisions of the abdomen

Laparoscopic hysterectomy

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women assigned for performing hysterectomy for abnormal uterine bleeding due to benign pathology.
• Uterine size by bimanual examination ≤14 weeks gestational size.
• Cases with uterine volumes ≤ 400cm3 will be included in this study.

You may not qualify if:

• Patients with BMI \> 30kg/m2
• Uteri \> 14 weeks gestational size by bimanual examination or volume \> 400cm3
• Women with positive pap smear for CIN or endometrial biopsy with atypia or carcinoma.
• Patient with other known body malignancy.
• Patient with other pelvic pathology, endometriosis or pelvic abscesses.
• Patients with abdominal scars.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

Location

MeSH Terms

Conditions

Uterine Hemorrhage

Interventions

Hysterectomy, Vaginal

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hysterectomy; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Amany A Makroum, MSc

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: comparison between laparoscopic hysterectomy versus non-descent vaginal hysterectomy using bipolar vessel sealers in patients with abnormal uterine bleeding

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: January 23, 2020
• Study Start: April 1, 2020
• Primary Completion: February 22, 2022
• Study Completion: April 28, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)