An interventional study of Robotic assisted hysterectomy in Rehabilitation, Pain, Postoperative and Wound Infection, sponsored by Herning Hospital. Withdrawn at 1 site in Denmark. Open to female participants aged 18 Years to 85 Years. 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 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.
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.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
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Exclusion Criteria:
Robotic single-site hysterectomy is performed in this arm
Procedure: Robotic assisted hysterectomy
Robotic multi-site hysterectomy is performed in this arm
Procedure: Robotic assisted hysterectomy
Periumbilical single incision vs multiple abdominal incisions for hysterectomy
Scar appearance and satisfaction
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
Time frame: Six months after operation
Scoring of abdominal pain
Visual analogue pain score with a minimum '0' and maximum '10'
Time frame: Visual analogue pain score at first, second, third, fourth, fifth, and sixth month after operation
Plan to share: Undecided — Awaiting consensus in the steering Group on 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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Herning Hospital