Comparison of TLH and LAVH With Over Than 500g

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hysterectomy, Benign Uterine Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other names: TLH: Total Laparoscopic Hysterectomy, LAVH: Laparoscopic Assisted Vaginal Hysterectomy

Primary outcomes

Postoperative complications

Time frame: 1 month after surgery

Incidence of postoperative complications

Sponsors and collaborators

Lead sponsor

Hanyang University Seoul Hospital

Other

Registry information

Official study title

Comparison of Total Laparoscopic Hysterectomy and Laparoscopic Assisted Vaginal Hysterectomy With Over Giant Uterus of Than 500g: A Randomized Controlled Trial

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: May 9, 2017
Registry last updated: May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed