Comparison of TLH and LAVH With Over Than 500g

Hanyang University Seoul Hospital

Status: Completed

Conditions: Hysterectomy, Benign Uterine Diseases

Treatments: Procedure: TLH vs LAVH

Study type: Interventional

Funder types: Other

Identifiers

NCT03146299

HYGY 4004

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

Group A: TLH

Active Comparator group

Treatment:

Procedure: TLH vs LAVH

Group B: LAVH

Active Comparator group

Treatment:

Procedure: TLH vs LAVH