Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04434066
• Other study ID #: STU-2019-1402
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: December 30, 2024
• Est. primary completion date: July 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Fibroid Uterus
• Hemorrhage
• Leiomyoma
• Surgery
• Uterine Bleeding
• Uterine Hemorrhage

Intervention

Procedure:
• Total Laparoscopic Hysterectomy
Participants will be randomized into either abdominal or vaginal morcellation at time of total laparoscopic hysterectomy

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

US Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)

US Food and Drug Administration. Updated Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean difference in total operating room time	Total operating room time is defined as skin incision to skin closure	intraoperative
Secondary	Mean difference from baseline in Body Image Scale Score 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	through study completion up to 6-weeks post-operatively
Secondary	Mean difference from baseline in Pain Visual Analogue Scale 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	through study completion up to 6-weeks post-operatively
Secondary	Mean difference from baseline in Quality of Recovery Score to 2-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	through study completion up to 6-weeks post-operatively
Secondary	Mean difference from baseline in Quality of Life Score 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	through study completion up to 6-weeks post-operatively
Secondary	Morcellation Time	Defined as specimen bag introduction to specimen bag removal	intraoperative
Secondary	Rates of Post-Operative Complications	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	through study completion up to 6-weeks post-operatively
Secondary	Mean difference in the dosages of morphine milligram equivalent (MME) for post-operative pain between abdominal and vaginal morcellation	The type and dosages of various narcotics will be recorded between both groups following surgery until 2-weeks post-operatively	after surgery to 2-weeks post-operatively