Vaginal Hysterectomy Versus Laparoscopically Assisted Vaginal Hysterectomy for Large Uteri

NCT02826304 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-07-11

No results posted yet for this study

Summary

The investigators compare between Vaginal Hysterectomy and Laparoscopically assisted vaginal hysterectomy in cases of large uteri weighing more than 280 gm regarding operative and Postoperative outcomes

Conditions

  • Minimally Invasive Hysterectomy in Large Uteri

Interventions

PROCEDURE

Vaginal hysterectomy

All the cases were performed by the same surgical team 1. Incision is made at the anterior cervical lip below the bladder reflection 2. Anterior peritoneal entry . 3. Douglas pouch entry. 4. The uterosacral ligaments and the cardinal ligaments are clamped, divided and ligated . 5. Uterine artery clamping division and ligation 6. After securing the uterine A., debulking procedures was performed in the form of bisection, coring or myomectomy 7. Utero-ovarian and round clamping-division and ligation ( in cases where oophorectomy was performed this part was done at the level of the infundibulo-pelvic ligament). 8. Hemostasis 9. The vaginal vault is closed after insertion of intraperitoneal drain and

PROCEDURE

Laparoscopic assisted vaginal hysterectomy

1. Uterine manipulator was inserted through the cervix to mobilize the uterus 2. Veress needle was inserted through the base of the umbilicus 3. creation of pneumoperitoneum 4. Insertion of 4 trocars one at the base of umbilicus for the camera and 3 lateral trocars 5. The round and the utero-ovarian ligament are coagulated and divided. 6. Dissection through the vesico-uterine space to displace bladder away from the cervix. 7. Uterine artery was coagulated and divided laparoscopically 8. anterior colpotomy over the cup of the uterine elevator. 9. Vaginal part starts with opening of douglas pouch and clamping , division and ligation of uterosacral and cardinal ligaments followed by removal of the uterus and closure of the vault. reinflation to ensure proper hemostasis.

Sponsors & Collaborators

  • Ain Shams Maternity Hospital

    lead OTHER

Principal Investigators

  • Fekrya A Salama, PhD · Ain Shams University Maternity Hospital

  • Ahmed A Tharwat, PhD · Ain Shams University Maternity Hospital

  • Walid E Mohamed, PhD · Ain Shams University Maternity Hospital

  • Ibrahim M Ibrahim, PhD · Ain Shams University Maternity Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-05-31
Completion
2016-07-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02826304 on ClinicalTrials.gov