Single Site Versus Multi Site Robotic Hysterectomy

October 14, 2024 updated by: Finn Lauszus, Herning Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herning, Denmark, 7400
        • Gynecology Dept. Herning Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Six months after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'
Visual analogue pain score at first, second, third, fourth, fifth, and sixth month after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herning Hospital

Collaborators

Herlev Hospital

Investigators

  • Principal Investigator: Finn F Lauszus, PhD, Herning Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2024

Primary Completion (Estimated)

October 16, 2024

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

June 7, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Single site robot study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Awaiting consensus in the steering Group on meeting, posters, abstracts, and publications

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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