Hysterectomy, Benign Uterine Diseases Clinical Trial
Official title:
Comparison of Total Laparoscopic Hysterectomy and Laparoscopic Assisted Vaginal Hysterectomy With Over Giant Uterus of Than 500g: A Randomized Controlled Trial
| Verified date | May 2017 |
| Source | Hanyang University Seoul Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 34 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 55 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hanyang University Seoul Hospital |
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Postoperative complications | Incidence of postoperative complications | 1 month after surgery |