Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy

NCT04434066 | Completed DMC

• 1 other identifier: STU-2019-1402
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Mean difference in total operating room time

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

  intraoperative

Secondary Outcomes (7)

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

  through study completion up to 6-weeks post-operatively

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

  through study completion up to 6-weeks post-operatively

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

  through study completion up to 6-weeks post-operatively

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

  through study completion up to 6-weeks post-operatively

• Morcellation Time

  intraoperative

Study Arms (2)

Abdominal Morcellation

EXPERIMENTAL

Abdominal morcellation will occur following completion of the hysterectomy. Route of incision will be either suprapubic or umbilical incision - based on surgeon preferences. All steps and instruments have been standardized for abdominal morcellation.

Procedure: Total Laparoscopic Hysterectomy

Vaginal Morcellation

EXPERIMENTAL

Vaginal morcellation will occur following completion of the hysterectomy. All steps and instruments have been standardized for vaginal morcellation.

Procedure: Total Laparoscopic Hysterectomy

Interventions

Total Laparoscopic Hysterectomy PROCEDURE

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

Abdominal Morcellation; Vaginal Morcellation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: All females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75229, United States

Location

Related Publications (11)

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 29112659 BACKGROUND

• 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.

  PMID: 25162248 BACKGROUND

• 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.

  PMID: 26205578 BACKGROUND

• 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.

  PMID: 26400045 BACKGROUND

• 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.

  PMID: 28483536 BACKGROUND

• 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.

  PMID: 26801067 BACKGROUND

• 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.

  PMID: 28586771 BACKGROUND

• 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.

  PMID: 22704765 BACKGROUND

• 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.

  PMID: 30075302 BACKGROUND

MeSH Terms

Conditions

Metrorrhagia; Uterine Hemorrhage; Leiomyoma; Pelvic Pain; Endometriosis

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; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Kimberly A Kho, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: January 8, 2020
• Primary Completion: July 19, 2022
• Study Completion: November 5, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)