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Respiration After Robot Assisted Laparoscopic Hysterectomy

Respiration Efter Hysterektomi Med Robotassisterad Laparoskopi- REHYR

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06806280
Acronym
REHYR
Enrollment
80
Registered
2025-02-04
Start date
2025-03-17
Completion date
2026-06-30
Last updated
2025-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Uterus Cervix

Keywords

respiration, hysterctomy, robot assisted surgery

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.

Interventions

None listed

Sponsors

Vastra Gotaland Region
CollaboratorOTHER_GOV
Göteborg University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Forced vital capacity, FVCUp to the first day after surgeryA spirometry including FVC will be performed in the sitting position according to international guidelines.

Secondary

MeasureTime frameDescription
Oxygen saturationUp to the first day after surgeryOxygen saturation will be performed via a finger probe.
Forced expiratory volume during one second, FEV1Up to the first day after surgeryA spirometry including FEV1 will be performed in the sitting position according to international guidelines.

Other

MeasureTime frameDescription
Patient assessed overall lung functionUp to the first day after surgeryThe patients will assess their overall lung function on a study-specifik numeric rating scale from 0-10 (best)
Peak Expiratory Flow, PEFUp to the first day after surgeryA spirometry including PEF will be performed in the sitting position according to international guidelines.

Countries

Sweden

Contacts

Primary ContactMonika Fagevik Olsén, PhD
monika.fagevik-olsen@gu.se+46 31 342 11 95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026