2-D and 3-D Laparoscopic Hysterectomy

Zealand University Hospital

Status: Unknown

Conditions: Fibroma, Bleeding

Treatments: Device: 3-D laparoscopy; Device: 2-D laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02610985

2D/3D hysterectomy

Details and patient eligibility

About

Background:

No randomised trials have been conducted, and only a single retrospective study exists comparing 3D and 2D laparoscopic hysterectomy. In that study, operative time for hysterectomy was significantly lower for 3D compared to 2D conventional laparoscopy. Complication rates were similar for the two groups. Thus, although one out of nine women is hysterectomized and although laparoscopy is one of the recommended routes of surgery, evidence whether to choose 2D laparoscopy, 3D laparoscopy is sparse.

Objective:

To compare pain and recurrence to usual activity level. Secondary to compare complications during the operation, postoperative complications, time to return to work, length of hospital stay and operative time.

Design:

Investigator-initiated, blinded, randomised controlled trial.

Intervention description:

Operative procedures follow the same principles and the same standard whether the surgeon's vision is 2D or 3D.

Trial size Roskilde/Herlev Hospital, Denmark:

200 patients in each arm of the study.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients referred for laparoscopic hysterectomy with or without bilateral salpingectomy or bilateral salpingooophorectomy for benign indications.

Exclusion criteria

• Women not suitable for laparoscopic hysterectomy including:

  • Ultrasound appraisal of uterus weight > 1000 gram
  • Need for prolapse surgery and therefore indication for vaginal hysterectomy.

• Inability to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups

2-Dimensional laparoscopic hysterectomy

Active Comparator group

Description:

traditional 2-D laparoscopy

Treatment:

Device: 2-D laparoscopy

3-Dimensional laparoscopic hysterectomy

Experimental group

Description:

experimental 3-D laparoscopy

Treatment:

Device: 3-D laparoscopy