Respiration After Robot Assisted Laparoscopic Hysterectomy

NCT ID: NCT06806280

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-17
• Study Completion Date: 2026-06-30

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.

Conditions

Cancer Uterus Cervix

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Monika Fagevik Olsén, PhD

Role: CONTACT

monika.fagevik-olsen@gu.se

+46 31 342 11 95

Facility Contacts

Monika Fagevik Olsén, PhD

Role: primary

monika.fagevik-olsen@vgregion.se

+46 707206189

Other Identifiers

FoU in VGR ID: 284148

Identifier Type: -

Identifier Source: org_study_id