Clinical trial NCT06806280: Respiration After Robot Assisted Laparoscopic Hysterectomy
Official title: Respiration Efter Hysterektomi Med Robotassisterad Laparoskopi- REHYR
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer Uterus Cervix
Keywords: respiration
hysterctomy
robot assisted surgery
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2025-02-04
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sahlgrenska University hospital, Gothenburg, Sweden

Brief 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.

Eligibility criteria: Inclusion Criteria:

* ≥18 years of age undergoing robotic-assisted laparoscopic hysterectomy for endometrial cancer or endometrial intraepitelial neoplasty..

Exclusion Criteria:

* cognitive impairment and difficulty understanding Swedish or English instructions.

Primary outcomes:
measure: Forced vital capacity, FVC
timeFrame: Up to the first day after surgery
Secondary outcomes:
measure: Oxygen saturation
timeFrame: Up to the first day after surgery
measure: Forced expiratory volume during one second, FEV1
timeFrame: Up to the first day after surgery
Other outcomes:
measure: Patient assessed overall lung function
timeFrame: Up to the first day after surgery
measure: Peak Expiratory Flow, PEF
timeFrame: Up to the first day after surgery
Locations:
city: Goteborg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References: