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Clinical Trials/NCT06806280
NCT06806280RecruitingNot Applicable

Respiration Efter Hysterektomi Med Robotassisterad Laparoskopi- REHYR

Göteborg University1 site in 1 country80 target enrollmentStarted: March 17, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
Forced vital capacity, FVC

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts 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.

Outcomes

Primary Outcomes

Forced vital capacity, FVC

Time Frame: Up to the first day after surgery

A spirometry including FVC will be performed in the sitting position according to international guidelines.

Secondary Outcomes

  • Oxygen saturation(Up to the first day after surgery)
  • Forced expiratory volume during one second, FEV1(Up to the first day after surgery)

Investigators

Sponsor
Göteborg University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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