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RecruitingNCT06806280

Respiration After Robot Assisted Laparoscopic Hysterectomy

Respiration Efter Hysterektomi Med Robotassisterad Laparoskopi- REHYR

Status
Recruiting
Phase
Study type
Observational
Enrollment
80 (estimated)
Sponsor
Göteborg University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Timeline

Start date
2025-03-17
Primary completion
2026-06-30
Completion
2026-06-30
First posted
2025-02-04
Last updated
2025-08-21

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT06806280. Inclusion in this directory is not an endorsement.