Clinical trial NCT03373513: Robotic-assisted Hysterectomy: Single- vs. Multi-port Laparoscopic Access
Official title: Robotic-assisted Hysterectomy: Single- vs. Multi-port Laparoscopic Access
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Activity, Motor
Pain
Wound
Keywords: Return-to-work, Visual analogue pain score, Cosmesis
Lead sponsor: Herning Hospital
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women are randomized to either robotic single site or multi port lapsoscopic hystrectomy
Primary purpose: TREATMENT

Brief summary: robotic single site surgery (R-SSH) is a novel technique, which may be superior to conventional multiport hysterectomy in select patients regarding cosmesis and postoperative pain. We, perform a randomized trial to compare R-SSH with multiport laparoscopic hysterectomy with regard to the postoperative rehabilitation, cosmesis, the operational cost, and the perioperative morbidity.

Detailed description: The study is scheduled to start February 2018 and compares robotic single-site hysterectomy to conventional multiport hysterectomy. Procedures are performed by an experienced two-surgeon team. Patients are randomized to either conventional multiport hysterectomy (N=62) or R-SSH (N=62). Eligibility criteria are the same as for study 1. Patient's satisfaction with body image and cosmesis is assessed at different time points pre- and postoperatively by means of validated cosmesis scales and Body Image Questionnaire. Postoperative pain and analgesia use will be registered as well as secondary outcome parameters as described above. A follow-up at 1, 3 and 6 month include evaluation of the scar and registration of port-site hernias and vaginal dehiscence or other complications. Interviews and diaries will include time of return to home and work, daily activities including sexuality The R-SSH is performed using da Vinci, Xi robotic system. One single port, diameter 2 cm is applied. Applying an additional assistant port is defined conversion of procedure The laparoscopy is performed using our standard equipment and 4 trocars, 5 mm each.

Socio-economical consequences of R-SSH versus conventional laparoscopic hysterectomy Study details in preparation

Sample size calculation was based a previous study on fast track hysterectomy, which showed a difference in return to work of 4 days. 62 women in each group is needed with standard deviation ±8 and a power of 80%. To include those not working, we calculated that with an expected visual analog pain score of 0.86 ±0.2 and 62 in each group the sample was sufficient to detect of difference of 0.1 in visual analog pain score with a power of 80%. All calculation are based on two-sided testing with alpha of 0.05.

Eligibility criteria: Inclusion Criteria:

* hysterectomy on benign indication,
* American Society of Anesthetists group 1 or 2,
* BMI less than 35 kg/m2
* uterine size less than 300 g estimated by ultrasound, using Ferraris formula.

Exclusion Criteria:

* adhesions
* prior extensive abdominal surgery
* prior midline incision,
* cutis laxa of abdomen surgery
* endometriosis
* more than 1 cesarean section
* malignant disease

Primary outcomes:
measure: Return-to-work
timeFrame: up to six months after operation or until work is resumed, whichever came first
Secondary outcomes:
measure: Pain measured by subjective score
timeFrame: Visual analogue pain score first, second, third, fourth, fifth, and six months after operation
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Gynecology Dept. Herning Hospital
Study officials:
affiliation: Gynecology Department, Herning Hospital
name: Finn F Lauszus, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: El Hachem L, Andikyan V, Mathews S, Friedman K, Poeran J, Shieh K, Geoghegan M, Gretz HF 3rd. Robotic Single-Site and Conventional Laparoscopic Surgery in Gynecology: Clinical Outcomes and Cost Analysis of a Matched Case-Control Study. J Minim Invasive Gynecol. 2016 Jul-Aug;23(5):760-8. doi: 10.1016/j.jmig.2016.03.005. Epub 2016 Mar 15.
citation: Golkar FC, Ross SB, Sperry S, Vice M, Luberice K, Donn N, Morton C, Hernandez JM, Rosemurgy AS. Patients' perceptions of laparoendoscopic single-site surgery: the cosmetic effect. Am J Surg. 2012 Nov;204(5):751-61. doi: 10.1016/j.amjsurg.2011.07.026.
citation: Sandberg EM, la Chapelle CF, van den Tweel MM, Schoones JW, Jansen FW. Laparoendoscopic single-site surgery versus conventional laparoscopy for hysterectomy: a systematic review and meta-analysis. Arch Gynecol Obstet. 2017 May;295(5):1089-1103. doi: 10.1007/s00404-017-4323-y. Epub 2017 Mar 29.
citation: Yeung PP Jr, Bolden CR, Westreich D, Sobolewski C. Patient preferences of cosmesis for abdominal incisions in gynecologic surgery. J Minim Invasive Gynecol. 2013 Jan-Feb;20(1):79-84. doi: 10.1016/j.jmig.2012.09.008.
citation: Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.