Robotic-assisted Hysterectomy: Single- vs. Multi-port Laparoscopic Access

• ClinicalTrials.gov Identifier: NCT03373513
• Recruitment Status: Not yet recruiting
• First Posted: December 14, 2017
• Last Update Posted: September 6, 2018
• Sponsor: Herning Hospital
• Information provided by (Responsible Party): Finn Friis Lauszus, Herning Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Activity, Motor; Pain; Wound	Procedure: Robotic single-site Hysterectomy; Procedure: Laparoscopic hysterectomy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Women are randomized to either robotic single site or multi port lapsoscopic hystrectomy
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Robotic-assisted Hysterectomy: Single- vs. Multi-port Laparoscopic Access
• Estimated Study Start Date: February 1, 2019
• Estimated Primary Completion Date: January 1, 2022
• Estimated Study Completion Date: December 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Robotic single-site hysterectomy; Robotic single-site hysterectomy is performed in this arm	Procedure: Robotic single-site Hysterectomy; Robotic assisted Periumbilical single incision hysterectomy
Active Comparator: Multiport Laparoscopy; Multiport Laparoscopic hysterectomy is performed in this other arm	Procedure: Laparoscopic hysterectomy; Multiport laparoscopic hysterectomy

Outcome Measures

Primary Outcome Measures :

1. Return-to-work [ Time Frame: up to six months after operation or until work is resumed, whichever came first ]
   Time from operation to return work

Secondary Outcome Measures :

1. Pain measured by subjective score [ Time Frame: Visual analogue pain score first, second, third, fourth, fifth, and six months after operation ]
   Visual analogue pain score with a minimum of '0' up to '10' on a 10 cm continious scale

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: women undergoing hysterectomy
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Finn F Lauszus, MD,PhD; 28495640; finlau@rm.dk

Locations

Denmark

Gynecology Dept. Herning Hospital

Herning, Denmark, 7400

Sponsors and Collaborators

Herning Hospital

Investigators

• Principal Investigator: Finn F Lauszus, MD,PhD; Gynecology Department, Herning Hospital

  Study Documents (Full-Text)

Documents provided by Finn Friis Lauszus, Herning Hospital:

Informed Consent Form  [PDF] December 12, 2017

Study Protocol  [PDF] December 12, 2017

More Information

Publications:

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.

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.

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. Review.

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.

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;(8):CD003677. doi: 10.1002/14651858.CD003677.pub5. Review.

• Responsible Party: Finn Friis Lauszus, Research Specialist, Senoir Consultant, Assistant Professor, Herning Hospital
• ClinicalTrials.gov Identifier: NCT03373513
• Other Study ID Numbers: R-SSH
• First Posted: December 14, 2017
• Last Update Posted: September 6, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: via meeting, posters, abstracts, and publications

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Finn Friis Lauszus, Herning Hospital:

Return-to-work, Visual analogue pain score, Cosmesis