Comparison of TLH and LAVH With Over Than 500g

NCT03146299 | Completed

• 1 other identifier: HYGY 4004
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hysterectomy, Benign Uterine Diseases

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  Incidence of postoperative complications

  1 month after surgery

Study Arms (2)

Group A: TLH

ACTIVE COMPARATOR

Procedure: TLH vs LAVH

Group B: LAVH

ACTIVE COMPARATOR

Procedure: TLH vs LAVH

Interventions

TLH vs LAVH PROCEDURE

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

Also known as: TLH: Total Laparoscopic Hysterectomy, LAVH: Laparoscopic Assisted Vaginal Hysterectomy

Group A: TLH; Group B: LAVH

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hanyang University Seoul Hospital: lead

Related Publications (3)

• 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.

  PMID: 7148906 BACKGROUND

• 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.

  PMID: 9050472 BACKGROUND

• 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.

  PMID: 12519109 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of the Division of Gynecologic Oncology and Gynecologic Minimally Invasive Surgery, Full-time faculty of the Department of Obstetrics and Gynecology, Hanyang University College of Medicine

Study Record Dates

• First Submitted: May 6, 2017
• First Posted: May 9, 2017
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 9, 2017

Record last verified: 2017-05