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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 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 and older (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 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

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to six months after operation or until work is resumed, whichever came first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Visual analogue pain score first, second, third, fourth, fifth, and six months after operation

Collaborators and Investigators

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

Sponsor

Herning Hospital

Investigators

  • Principal Investigator: Finn F Lauszus, MD,PhD, Gynecology Department, 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)

February 1, 2019

Primary Completion (Estimated)

January 1, 2022

Study Completion (Estimated)

December 1, 2022

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

December 13, 2017

First Posted (Actual)

December 14, 2017

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

Other Study ID Numbers

  • R-SSH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

via 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.

Clinical Trials on Pain

Clinical Trials on Robotic single-site Hysterectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe