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Single Site Versus Multi Site Robotic Hysterectomy

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ClinicalTrials.gov Identifier: NCT03662451
Recruitment Status : Not yet recruiting
First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Herlev Hospital
Information provided by (Responsible Party):
Finn Friis Lauszus, Herning Hospital

Study Description
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Brief Summary:
Robotic single site surgery (R-SSH) is a novel technique, which may be superior to multi site hysterectomy (R-MSH) in select patients regarding cosmesis and postoperative pain. A randomized trial is performed to compare R-SSH with R-MSH with regard to the postoperative rehabilitation, cosmesis, the operational cost, and the perioperative morbidity.

Condition or disease Intervention/treatment Phase
Rehabilitation Pain, Postoperative Wound Infection Procedure: Robotic assisted hysterectomy Not Applicable

Detailed Description:

The study is scheduled to start November 2018 and compares robotic single site to multi site hysterectomy. Procedures are performed on two locations, Herning and Herlev Hospitals, by experienced surgeons. Patients are randomized to either R-SSH (No.=62) or R-MSH (No.=62). 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 and photo-evaluations.

Postoperative pain and split times spent at the operation theatre will be registered as secondary outcome parameters.

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 R-MSH is performed using standard equipment and 4 trocars, 5 mm each.

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, the calculation was performed with an expected visual analog pain score of 0.86 ±0.2 and 62 in each group and suggested that 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
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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 site hysterectomy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Site Versus Multi Site Robotic Hysterectomy
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Robotic single-site hysterectomy
Robotic single-site hysterectomy is performed in this arm
 Procedure: Robotic assisted hysterectomy
Periumbilical single incision vs multiple abdominal incisions for hysterectomy
Active Comparator: Robotic multi-site hysterectomy
Robotic multi-site hysterectomy is performed in this arm
 Procedure: Robotic assisted hysterectomy
Periumbilical single incision vs multiple abdominal incisions for hysterectomy


Outcome Measures
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Primary Outcome Measures :
  1. Scar appearance and satisfaction [ Time Frame: Six months after operation ]
    Appearance and evaluation of scar by POSAS scale (see www.posas.org and reference below) which has a scale from 1-10, where 1 is minimum and 10 is maximum; on scar's pain, its itching, on difference from normal skin, on stiffness, on thickness, on irregularity and general satisfaction


Secondary Outcome Measures :
  1. Scoring of abdominal pain [ Time Frame: Visual analogue pain score at first, second, third, fourth, fifth, and sixth month after operation ]
    Visual analogue pain score with a minimum '0' and maximum '10'


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hysterectomy on benign indication,
  • American Society of Anesthetists group 1 or 2,
  • BMI less than 30 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662451


Contacts
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Contact: Finn F Lauszus, PhD +45 78 434614 finlau@rm.dk
Contact: Carsten Byrialsen +45 21609156

Locations
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Denmark
Gynecology Dept. Herning Hospital
Herning, Denmark, 7400
Sponsors and Collaborators
Herning Hospital
Herlev Hospital
Investigators
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Principal Investigator: Finn F Lauszus, PhD Herning Hospital
More Information
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Publications:

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Responsible Party: Finn Friis Lauszus, Associate professor, Herning Hospital
ClinicalTrials.gov Identifier: NCT03662451    
Other Study ID Numbers: Single site robot study
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Awaiting consensus in the steering Group on meeting, posters, abstracts, and publications

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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
Cosmesis
Visual analogue pain score
Additional relevant MeSH terms:
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Wound Infection
Pain, Postoperative
Postoperative Complications
Pathologic Processes
 Pain
Neurologic Manifestations
Infections