Sahlgrenska University Hospital
Gothenburg, 405 30, Sweden
Location status: Recruiting
NCT Number: NCT06806280
The study will investigate how respiratory function is affected by robot-assisted surgery. Previous studies have investigated the impact after open and laparoscopic surgery, but there are no studies yet after robot-assisted surgery.
80 women undergoing robot-assisted hysterectomy will undergo measurements of lung function and oxygen saturation before and after the operation.
Interested in participating?
Request Info18 year and older
Female
Observational
Gothenburg, 405 30, Sweden
Location status: Recruiting
It is well known that respiration is affected during surgery under general anesthesia. Despite optimal ventilation in a respirator during the procedure, lung volume decreases, leading to atelectasis. Other effects include increased secretions in the airways, while ciliary function deteriorates. After surgery performed under general anesthesia, the patient therefore often develops hypoventilation. This can largely be explained by lingering effects of anesthetics, reduced lung volumes, atelectasis, pain and immobilization.
In a previous study, lung effects have been studied in open and laparoscopic surgery, including after hysterectomy. With the development of robotic surgery and operations on patients with an increasing number of risk factors, complementary studies are needed.
The aim of the study is to investigate changes in lung function during robot-assisted laparoscopic surgery due to uterine cancer or endometrial intraepithelial neoplasia in the uterus, and to search for predictors of low lung volume, hypoxia and pneumonia.
A consecutive series of 80 patients undergoing robot-assisted hysterectomy will be included in the study.
At the preoperative visit, a dynamic spirometry (Easyone, ndd, Medical Technologies, Switzerland) is performed in a sitting position according to international guidelines. Before the test, oxygen saturation will be measured with a finger probe. In addition, patients will assess their lung function on a visual analogue scale
Postoperatively, patients will undergo the same spirometry 2-3 hours after arrival at the postoperative ward, before the first mobilization. The test will be performed while sitting in bed with the head of the bed elevated at 60˚ and with optimal pain relief (VAS<4). Pre-test pain assessment will be recorded as well as the patient's assessment of their lung function. The day after surgery, the same test will be performed again (including assessment of pain and lung function) in the morning before and after mobilization to walk in the room. During the hospitalization, mobilization and any breathing exercises are recorded on a special protocol.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to the first day after surgery
A spirometry including FVC will be performed in the sitting position according to international guidelines.
Time frame: Up to the first day after surgery
Oxygen saturation will be performed via a finger probe.
Time frame: Up to the first day after surgery
A spirometry including FEV1 will be performed in the sitting position according to international guidelines.
Time frame: Up to the first day after surgery
The patients will assess their overall lung function on a study-specifik numeric rating scale from 0-10 (best)
Time frame: Up to the first day after surgery
A spirometry including PEF will be performed in the sitting position according to international guidelines.
Contact information is provided by the study sponsor or research team.
Göteborg University
Other
Respiration Efter Hysterektomi Med Robotassisterad Laparoskopi- REHYR
Acronym: REHYR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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