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Comparison of TLH and LAVH With Over Than 500g

Primary Purpose

Hysterectomy, Benign Uterine Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TLH vs LAVH
Sponsored by
Hanyang University Seoul Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hysterectomy, Benign Uterine Diseases

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Have the indication for hysterectomy for a supposed benign uterine disease
  • Have a giant uterus of 500g or more
  • Estimation of uterine weight more than 500g
  • Uterine myoma size at 4 months or more after pregnancy due to pelvic examination
  • The length of the long axis of one uterine myoma is more than 8cm or the length of the long axis for over 2 uterine myomas is more than 6cm
  • Have been not pregnant at the time of presentation
  • Have been appropriated medical status for laparoscopic surgery (surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)

Exclusion Criteria:

  • Have a suspicion of malignancy or malignant tumors (cervical cancer, ovarian cancer, fallopian tube cancer, peritoneal cancer, Endometrial cancer)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group A: TLH

    Group B: LAVH

    Arm Description

    Outcomes

    Primary Outcome Measures

    Postoperative complications
    Incidence of postoperative complications

    Secondary Outcome Measures

    Full Information

    First Posted
    May 6, 2017
    Last Updated
    May 8, 2017
    Sponsor
    Hanyang University Seoul Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03146299
    Brief Title
    Comparison of TLH and LAVH With Over Than 500g
    Official Title
    Comparison of Total Laparoscopic Hysterectomy and Laparoscopic Assisted Vaginal Hysterectomy With Over Giant Uterus of Than 500g: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2014 (Actual)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hanyang University Seoul Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Since the introduction of total laparoscopic hysterectomy in 1989, laparoscopic gynecologic surgery has undergone many advances. TLH or LAVH has the advantages of faster recovery, fewer complications and shorter hospitalization compared to total abdominal hysterectomy. However, the hysterectomy for giant uterus has the difficulty of delivering the uterus out of the body. According to the results of TLH, LAVH and abdominal hysterectomy, TLH and LAVH show the postoperative complications were less frequent (3) and the postoperative recovery (4) and return to daily life were faster than total abdominal hysterectomy (3) even if it took longer operation time. Therefore, laparoscopic hysterectomy has many advantages over abdominal hysterectomy and indications are increasing. However, there has not yet been a direct comparison between TLH and VALH for large uterine surgery. In this study, we compared the results including the complications, hospitalization period and so on., in undergoing operation and post-operation between TLH and LAVH for the removal of giant uterus, which is predicted to be over 500 g.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hysterectomy, Benign Uterine Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A: TLH
    Arm Type
    Active Comparator
    Arm Title
    Group B: LAVH
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    TLH vs LAVH
    Other Intervention Name(s)
    TLH: Total Laparoscopic Hysterectomy, LAVH: Laparoscopic Assisted Vaginal Hysterectomy
    Intervention Description
    TLH: The subjects undergoing laparoscopic hysterectomy with a giant uterus of 500 g or more LAVH: The subjects undergoing Laparoscopic Assisted Vaginal Hysterectomy with a giant uterus of 500 g or more
    Primary Outcome Measure Information:
    Title
    Postoperative complications
    Description
    Incidence of postoperative complications
    Time Frame
    1 month after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have the indication for hysterectomy for a supposed benign uterine disease Have a giant uterus of 500g or more Estimation of uterine weight more than 500g Uterine myoma size at 4 months or more after pregnancy due to pelvic examination The length of the long axis of one uterine myoma is more than 8cm or the length of the long axis for over 2 uterine myomas is more than 6cm Have been not pregnant at the time of presentation Have been appropriated medical status for laparoscopic surgery (surgery (American Society of Anesthesiologists Physical Status classification 1 or 2) Exclusion Criteria: Have a suspicion of malignancy or malignant tumors (cervical cancer, ovarian cancer, fallopian tube cancer, peritoneal cancer, Endometrial cancer)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    7148906
    Citation
    Dicker RC, Greenspan JR, Strauss LT, Cowart MR, Scally MJ, Peterson HB, DeStefano F, Rubin GL, Ory HW. Complications of abdominal and vaginal hysterectomy among women of reproductive age in the United States. The Collaborative Review of Sterilization. Am J Obstet Gynecol. 1982 Dec 1;144(7):841-8. doi: 10.1016/0002-9378(82)90362-3.
    Results Reference
    background
    PubMed Identifier
    9050472
    Citation
    Carter JE, Ryoo J, Katz A. Laparoscopic-assisted vaginal hysterectomy: a case control comparative study with total abdominal hysterectomy. J Am Assoc Gynecol Laparosc. 1994 Feb;1(2):116-21. doi: 10.1016/s1074-3804(05)80773-x.
    Results Reference
    background
    PubMed Identifier
    12519109
    Citation
    Hwang JL, Seow KM, Tsai YL, Huang LW, Hsieh BC, Lee C. Comparative study of vaginal, laparoscopically assisted vaginal and abdominal hysterectomies for uterine myoma larger than 6 cm in diameter or uterus weighing at least 450 g: a prospective randomized study. Acta Obstet Gynecol Scand. 2002 Dec;81(12):1132-8. doi: 10.1034/j.1600-0412.2002.811206.x.
    Results Reference
    background

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    Comparison of TLH and LAVH With Over Than 500g

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