Comparison of TLH and LAVH With Over Than 500g

Not Applicable

Completed

• Conditions: Hysterectomy, Benign Uterine Diseases
• Interventions: Procedure: TLH vs LAVH

• Registration Number: NCT03146299
• Lead Sponsor: Hanyang University Seoul Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-01
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2017-05
• Study First Submitted: 2017-05-06
• Study First Submitted QC: 2017-05-08
• Last Update Submitted: 2017-05-08
• Study First Posted: 2017-05-09
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: TLH	TLH vs LAVH	-
Group B: LAVH	TLH vs LAVH	-

Primary Outcome Measures

Name	Time	Method
Postoperative complications	1 month after surgery	Incidence of postoperative complications