Clinical trial NCT04434066: Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy
Official title: A Comparison of Perioperative and Patient-Centered Outcomes with Abdominal Versus Vaginal Morcellation: a Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormal Uterine Bleeding
Uterine Bleeding
Fibroid Uterus
Surgery
Keywords: hysterectomy
abnormal uterine bleeding
morcellation
abdominal
vaginal
surgery
laparoscopic
laparoscopy
total hysterectomy
pelvic pain
endometriosis
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

1. To evaluate differences in total operating time between subjects undergoing AM compared to VM.
2. To evaluate differences in morcellation time between AM and VM.
3. To evaluate differences in the amount of total narcotic use during hospital admission between AM and VM through morphine milligram equivalents (MME).
4. 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.
5. 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.
6. To evaluate differences in body image survey (BIS) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group.
7. 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.
8. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean difference in total operating room time
timeFrame: intraoperative
Secondary outcomes:
measure: Mean difference from baseline in Body Image Scale Score to 6-weeks post-operatively
timeFrame: through study completion up to 6-weeks post-operatively
measure: Mean difference from baseline in Pain Visual Analogue Scale to 6-weeks post-operatively
timeFrame: through study completion up to 6-weeks post-operatively
measure: Mean difference from baseline in Quality of Recovery Score to 2-weeks post-operatively
timeFrame: through study completion up to 6-weeks post-operatively
measure: Mean difference from baseline in Quality of Life Score to 6-weeks post-operatively
timeFrame: through study completion up to 6-weeks post-operatively
measure: Morcellation Time
timeFrame: intraoperative
measure: Rates of Post-Operative Complications
timeFrame: through study completion up to 6-weeks post-operatively
measure: Mean difference in the dosages of morphine milligram equivalent (MME) for post-operative pain between abdominal and vaginal morcellation
timeFrame: after surgery to 2-weeks post-operatively
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Kimberly A Kho, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: US Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)
citation: US Food and Drug Administration. Updated Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)
citation: Siedhoff MT, Cohen SL. Tissue Extraction Techniques for Leiomyomas and Uteri During Minimally Invasive Surgery. Obstet Gynecol. 2017 Dec;130(6):1251-1260. doi: 10.1097/AOG.0000000000002334.
citation: Cohen SL, Einarsson JI, Wang KC, Brown D, Boruta D, Scheib SA, Fader AN, Shibley T. Contained power morcellation within an insufflated isolation bag. Obstet Gynecol. 2014 Sep;124(3):491-497. doi: 10.1097/AOG.0000000000000421.
citation: Solima E, Scagnelli G, Austoni V, Natale A, Bertulessi C, Busacca M, Vignali M. Vaginal Uterine Morcellation Within a Specimen Containment System: A Study of Bag Integrity. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1244-6. doi: 10.1016/j.jmig.2015.07.007. Epub 2015 Jul 20.
citation: Moawad GN, Abi KhalIL ED, Opoku-Anane J, Marfori CQ, Harman AC, Fisher S, Levy M, Robinson JK. Comparison of methods of morcellation: manual versus power. Acta Obstet Gynecol Scand. 2016 Jan;95(1):52-4. doi: 10.1111/aogs.12783. Epub 2015 Oct 19.
citation: Meurs EAIM, Brito LG, Ajao MO, Goggins ER, Vitonis AF, Einarsson JI, Cohen SL. Comparison of Morcellation Techniques at the Time of Laparoscopic Hysterectomy and Myomectomy. J Minim Invasive Gynecol. 2017 Jul-Aug;24(5):843-849. doi: 10.1016/j.jmig.2017.04.023. Epub 2017 May 5.
citation: Venturella R, Rocca ML, Lico D, La Ferrera N, Cirillo R, Gizzo S, Morelli M, Zupi E, Zullo F. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016 May;105(5):1369-1376. doi: 10.1016/j.fertnstert.2015.12.133. Epub 2016 Jan 19.
citation: Frasca C, Degli Esposti E, Arena A, Tuzzato G, Moro E, Martelli V, Seracchioli R. Can In-Bag Manual Morcellation Represent an Alternative to Uncontained Power Morcellation in Laparoscopic Myomectomy? A Randomized Controlled Trial. Gynecol Obstet Invest. 2018;83(1):52-56. doi: 10.1159/000477171. Epub 2017 Jun 7.
citation: Ghezzi F, Cromi A, Uccella S, Bogani G, Serati M, Bolis P. Transumbilical versus transvaginal retrieval of surgical specimens at laparoscopy: a randomized trial. Am J Obstet Gynecol. 2012 Aug;207(2):112.e1-6. doi: 10.1016/j.ajog.2012.05.016. Epub 2012 May 23.
citation: Cohen SL, Clark NV, Ajao MO, Brown DN, Gargiulo AR, Gu X, Einarsson JI. Prospective Evaluation of Manual Morcellation Techniques: Minilaparotomy versus Vaginal Approach. J Minim Invasive Gynecol. 2019 May-Jun;26(4):702-708. doi: 10.1016/j.jmig.2018.07.020. Epub 2018 Aug 1.