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NCT Number: NCT06806280

Respiration After Robot Assisted Laparoscopic Hysterectomy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sahlgrenska University Hospital

Gothenburg, 405 30, Sweden

Location status: Recruiting

Location contact

Monika Fagevik Olsén, PhD

CONTACT

[email protected]

+46 707206189

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Oxygen saturation

    Time frame: Up to the first day after surgery

    Oxygen saturation will be performed via a finger probe.

  2. Forced expiratory volume during one second, FEV1

    Time frame: Up to the first day after surgery

    A spirometry including FEV1 will be performed in the sitting position according to international guidelines.

Other outcomes

  1. Patient assessed overall lung function

    Time frame: Up to the first day after surgery

    The patients will assess their overall lung function on a study-specifik numeric rating scale from 0-10 (best)

  2. Peak Expiratory Flow, PEF

    Time frame: Up to the first day after surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Monika Fagevik Olsén, PhD

CONTACT

[email protected]

+46 31 342 11 95

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Vastra Gotaland Region

Registry information

Official study title

Respiration Efter Hysterektomi Med Robotassisterad Laparoskopi- REHYR

Acronym: REHYR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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