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
About this trial
This is an interventional treatment trial for Hysterectomy, Benign Uterine Diseases
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)
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
NCT ID
NCT03146299
First Posted
May 6, 2017
Last Updated
May 8, 2017
Sponsor
Hanyang University Seoul Hospital
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
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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
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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
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Comparison of TLH and LAVH With Over Than 500g
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