An interventional study of Robotic single-site Hysterectomy and Laparoscopic hysterectomy in Activity, Motor, Pain and Wound, sponsored by Herning Hospital. Withdrawn at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Herning Hospital · Not applicable, Interventional, and Treatment
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
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Compared within Pain, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Robotic single-site hysterectomy is performed in this arm
Procedure: Robotic single-site Hysterectomy
Multiport Laparoscopic hysterectomy is performed in this other arm
Procedure: Laparoscopic hysterectomy
Robotic assisted Periumbilical single incision hysterectomy
Multiport laparoscopic hysterectomy
Return-to-work
Time from operation to return work
Time frame: up to six months after operation or until work is resumed, whichever came first
Pain measured by subjective score
Visual analogue pain score with a minimum of '0' up to '10' on a 10 cm continious scale
Time frame: Visual analogue pain score first, second, third, fourth, fifth, and six months after operation
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — via meeting, posters, abstracts, and publications
This study is withdrawn, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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