Respiration After Robot Assisted Laparoscopic Hysterectomy (REHYR)

Respiration Efter Hysterektomi Med Robotassisterad Laparoskopi- REHYR

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Uterus Cervix

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Monika Fagevik Olsén, PhD; Phone Number: +46 31 342 11 95; Email: monika.fagevik-olsen@gu.se

Study Locations

• Sweden
  • Goteborg, Sweden, 405 30
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Monika Fagevik Olsén, PhD; Phone Number: +46 707206189; Email: monika.fagevik-olsen@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Sahlgrenska University hospital, Gothenburg, Sweden

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study group; The study will include a consecutive series of 80 women ≥18 years of age undergoing robotic-assisted laparoscopic hysterectomy for endometrial cancer or endometrial intraepithelial neoplasia. Exclusion criteria are: cognitive impairment and difficulty understanding Swedish or English instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced vital capacity, FVC	A spirometry including FVC will be performed in the sitting position according to international guidelines.	Up to the first day after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen saturation	Oxygen saturation will be performed via a finger probe.	Up to the first day after surgery
Forced expiratory volume during one second, FEV1	A spirometry including FEV1 will be performed in the sitting position according to international guidelines.	Up to the first day after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient assessed overall lung function	The patients will assess their overall lung function on a study-specifik numeric rating scale from 0-10 (best)	Up to the first day after surgery
Peak Expiratory Flow, PEF	A spirometry including PEF will be performed in the sitting position according to international guidelines.	Up to the first day after surgery

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Vastra Gotaland Region

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): February 4, 2025

Study Record Updates

• Last Update Posted (Actual): August 21, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: respiration; robot assisted surgery; hysterctomy
• Other Study ID Numbers: FoU in VGR ID: 284148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No