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Completed

NCT Number: NCT04434066

Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy

The purpose of the study is to investigate differences in perioperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in participants undergoing laparoscopic total hysterectomies in a randomized controlled trial.

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Key information

Conditions

Abnormal Uterine Bleeding Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibroid Uterus Genital Diseases Genital Diseases, Female Hemorrhage Leiomyoma Metrorrhagia Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Surgery Urogenital Diseases Uterine Bleeding Uterine Diseases Uterine Hemorrhage

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75229, United States

About this study

The purpose of the proposed study is to investigate differences in intraoperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in subjects undergoing laparoscopic total hysterectomies in a randomized surgical trial.

Objectives:

  • To evaluate differences in total operating time between subjects undergoing AM compared to VM.
  • To evaluate differences in morcellation time between AM and VM.
  • To evaluate differences in the amount of total narcotic use during hospital admission between AM and VM through morphine milligram equivalents (MME).
  • To evaluate differences in the patient's subjective pain assessment via Visual Analogue Scale (VAS) before surgery, at 2-weeks, and at 6 week post-operative visits in both AM and VM groups.
  • To evaluate differences in the patient's pain medication usage as reported by the patient verbally at 24-hours post-operatively and 2-weeks post surgery between AM and VM groups.
  • To evaluate differences in body image survey (BIS) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group.
  • To evaluate differences in overall Quality of Life (QoL) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group.
  • To evaluate differences in Quality of Recovery (QoR) scores at enrollment and at 24-hours post-operatively, and then 2-weeks post surgery between AM and VM group.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All benign total laparoscopic hysterectomy and/or robotic-assisted hysterectomy, +/- unilateral salpingo-oophorectomy or bilateral salpingo-oophorectomy
  • Adnexectomy, cystectomy, tubal procedures at time of hysterectomy
  • Age >18 years old
  • Uterus >12 weeks, or >250 grams (based on imaging), or requiring morcellation based on clinical judgment at time of pre-operative enrollment
  • English and Spanish speaking

Exclusion criteria

  • Pre-malignant conditions (i.e. endometrial intraepithelial neoplasia, high-grade cervical intraepithelial neoplasia), known gynecologic malignancy, and any contraindications to abdominal or vaginal morcellation
  • Planned concurrent procedures (i.e. hernia repair, bowel resections, anti-incontinence procedures, prolapse repair, and mastectomy)
  • Appendectomy for endometriosis is not excluded
  • No chronic pain disorders requiring medical management (endometriosis can be included)
  • Planned abdominal hysterectomy or vaginal hysterectomy candidates
  • Conversion to laparotomy or inability to complete morcellation
  • Contraindications to laparoscopy

Treatment and study plan

Total laparoscopic hysterectomy

Procedure

Participants will be randomized into either abdominal or vaginal morcellation at time of total laparoscopic hysterectomy

Primary outcomes

  1. Mean difference in total operating room time

    Time frame: intraoperative

    Total operating room time is defined as skin incision to skin closure

Secondary outcomes

  1. Mean difference from baseline in Body Image Scale Score to 6-weeks post-operatively

    Time frame: through study completion up to 6-weeks post-operatively

    Body Image Scale will be collected at baseline, and 6-weeks post-operatively. Body Image Scale will be scored from 10 to 40 points maximum, with higher scores referring to being "very dissatisfied" with overall body image

  2. Mean difference from baseline in Pain Visual Analogue Scale to 6-weeks post-operatively

    Time frame: through study completion up to 6-weeks post-operatively

    Pain Visual Analogue Scale will be collected at baseline, and 6-weeks post-operatively. VAS scale will be measured from 0 to 10mm, with higher scores referring to more pain experienced

  3. Mean difference from baseline in Quality of Recovery Score to 2-weeks post-operatively

    Time frame: through study completion up to 6-weeks post-operatively

    Quality of Recovery will be collected at baseline, 24-hours, and 2-weeks post-operatively. Quality of Recovery will be scored from 10 to 100, with higher scores referring to better quality of recovery

  4. Mean difference from baseline in Quality of Life Score to 6-weeks post-operatively

    Time frame: through study completion up to 6-weeks post-operatively

    Quality of Life Scores will be collected at baseline, and 6-weeks post-operatively. The Quality of Life Score will be scored from 11 to 44, with higher scores referring to better quality of life

  5. Morcellation Time

    Time frame: intraoperative

    Defined as specimen bag introduction to specimen bag removal

  6. Rates of Post-Operative Complications

    Time frame: through study completion up to 6-weeks post-operatively

    Post-operative complications will be collected including: readmission to the hospital or emergency room, number of visits seen in the clinic, diagnoses of infection, bleeding, blood transfusions, surgery-related injuries, reoperations, and overall mortality

  7. Mean difference in the dosages of morphine milligram equivalent (MME) for post-operative pain between abdominal and vaginal morcellation

    Time frame: after surgery to 2-weeks post-operatively

    The type and dosages of various narcotics will be recorded between both groups following surgery until 2-weeks post-operatively

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

A Comparison of Perioperative and Patient-Centered Outcomes with Abdominal Versus Vaginal Morcellation: a Randomized-Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Jun 16, 2020
Registry last updated
Nov 8, 2024

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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