Clinical trial NCT02610985: 2-D and 3-D Laparoscopic Hysterectomy
Official title: 3-dimensional Versus Conventional Laparoscopy in Patients Undergoing Total Hysterectomy for Benign Disease - A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibroma, Bleeding
Keywords: Imaging, Three-Dimensional
Hysterectomy
laparoscopic hysterectomy
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Score on SF 36 psychical health survey 6 weeks after surgery
timeFrame: 6 weeks
measure: Pain (VAS score) assessed immediately at return to the gynaecological unit (about 5 hours postoperatively) and (VAS score) in the morning days 1-3 postoperatively.
timeFrame: 3 days
Secondary outcomes:
measure: Major complications during the operation, postoperative complications
timeFrame: 6 weeks
measure: Minor complications during the operation, postoperative complications
timeFrame: 6 weeks
measure: Score on SF 36 mental health survey 6 weeks after surgery
timeFrame: 6 weeks
measure: Length of hospital stay
timeFrame: 6 weeks
measure: Operative time
timeFrame: 4 hours
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Sjaellands Univercety Hospital
state: Zealand
Study officials:
References:
citation: Hoffmann E, Bennich G, Larsen CR, Lindschou J, Jakobsen JC, Lassen PD. 3-dimensional versus conventional laparoscopy for benign hysterectomy: protocol for a randomized clinical trial. BMC Womens Health. 2017 Sep 7;17(1):76. doi: 10.1186/s12905-017-0434-7.