Respiration After Robot Assisted Laparoscopic Hysterectomy

NCT06806280 | Recruiting

• 1 other identifier: FoU in VGR ID: 284148
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Uterus Cervix

Keywords

respiration; hysterctomy; robot assisted surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Oxygen saturation

  Up to the first day after surgery

• Forced expiratory volume during one second, FEV1

  Up to the first day after surgery

Other Outcomes (2)

• Patient assessed overall lung function

  Up to the first day after surgery

• Peak Expiratory Flow, PEF

  Up to the first day after surgery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women develop uterus cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sahlgrenska University hospital, Gothenburg, Sweden

You may qualify if:

• ≥18 years of age undergoing robotic-assisted laparoscopic hysterectomy for endometrial cancer or endometrial intraepitelial neoplasty..

You may not qualify if:

• cognitive impairment and difficulty understanding Swedish or English instructions.

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 405 30, Sweden

RECRUITING

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Monika Fagevik Olsén, PhD

CONTACT

+46 31 342 11 95; monika.fagevik-olsen@gu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 4, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-03

Locations

SE (1)