Short- and Long-term Effects of Robot-assisted Plication in Diaphragmatic Paralysis

NCT06919185 | Not Yet Recruiting

• 1 other identifier: 2025-01028-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Diaphragmatic paralysis may lead to severe symptoms such as breathlessness and reduced physical capacity. Diaphragmatic plication using Robotic-Assisted Thoracic Surgery (RATS) is a minimally invasive surgical technique developed to improve lung function by correcting diaphragmatic elevation. While its benefits have been reported in retrospective reports, prospective studies are lacking. This prospective observational cohort study aimsto evaluate the short- and long-term effects of robot-assisted diaphragmatic plication on subjective breathlessness, physical performance, lung function, blood gases, and imaging findings at five Swedish university hospitals: Gothenburg, Linköping, Lund, Umeå, and Uppsala. Patients will be assessed preoperatively and postoperatively after one to three months and after one and three years.

Conditions

Diaphragmatic Plication; Diaphragmatic Paralysis; Diaphragmatic Eventration

Keywords

RATS; robot-assisted thoracic surgery; plication; dyspnea; thoracotomy

Outcome Measures

Primary Outcomes (1)

• 6-minute walking distance (6MWD).

  The patients are asked to walk as far as possible on a flat, straight surface for six minutes, and the total distance walked is measured.

  From enrollment to end of observation att 3 years.

Secondary Outcomes (14)

• The modified Borg Scale

  From enrollment to end of observation att 3 years.

• The modified Medical Research Council (mMRC) dyspnea scale

  From enrollment to end of observation att 3 years.

• The Dyspnea-12 questionnaire

  From enrollment to end of observation att 3 years.

• The EQ-5D questionnaire

  From enrollment to end of observation att 3 years.

• Spirometry

  From enrollment to end of observation att 3 years.

Study Arms (1)

Patients accepted for Robot-assisted diaphragmatic plication

Patients with symptomatic unilateral diaphragmatic paralysis persisting for ≥1 year accepted for Robot-assisted diaphragmatic plication at 5 Swedish University Hospitals, Gothenburg, Linköping, Lund, Umeå, and Uppsala

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unilateral diaphragmatic paralysis

You may qualify if:

• Patients with symptomatic unilateral diaphragmatic paralysis persisting for ≥1 year
• Patients are scheduled for RATS at thoracic surgery clinics in five Swedish university hospitals (Gothenburg, Linköping, Lund, Umeå, and Uppsala).

You may not qualify if:

• Inability to complete forms in Swedish
• Neuromuscular disease as the cause of diaphragmatic paralysis
• Other significant causes of dyspnea
• Impaired physical capacity from other causes than diaphragmatic paralysis.

Sponsors & Collaborators

• Uppsala County Council, Sweden: lead
• Uppsala University: collaborator

Study Sites (1)

Department of Medical Sciences, Lung-, Allergy-, and Sleep Research, Uppsala University/Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Related Publications (22)

• Marmor HN, Xiao D, Godfrey CM, Nesbitt JC, Gillaspie EA, Lambright ES, Bacchetta M, Moe DM, Deppen SA, Grogan EL. Short-term outcomes of robotic-assisted transthoracic diaphragmatic plication. J Thorac Dis. 2023 Apr 28;15(4):1605-1613. doi: 10.21037/jtd-22-442. Epub 2023 Mar 28.

  PMID: 37197490 BACKGROUND

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• Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.

  PMID: 22743675 BACKGROUND

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  PMID: 9366889 BACKGROUND

• Yorke J, Moosavi SH, Shuldham C, Jones PW. Quantification of dyspnoea using descriptors: development and initial testing of the Dyspnoea-12. Thorax. 2010 Jan;65(1):21-6. doi: 10.1136/thx.2009.118521. Epub 2009 Dec 8.

  PMID: 19996336 BACKGROUND

• Olsson M, Ekstrom M. Validation of the Dyspnoea-12 and Multidimensional Dyspnea profile among older Swedish men in the population. BMC Geriatr. 2022 Jun 2;22(1):477. doi: 10.1186/s12877-022-03166-5.

  PMID: 35655151 BACKGROUND

• Munari AB, Gulart AA, Dos Santos K, Venancio RS, Karloh M, Mayer AF. Modified Medical Research Council Dyspnea Scale in GOLD Classification Better Reflects Physical Activities of Daily Living. Respir Care. 2018 Jan;63(1):77-85. doi: 10.4187/respcare.05636. Epub 2017 Sep 5.

  PMID: 28874609 BACKGROUND

• Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.

  PMID: 25359355 BACKGROUND

• Casanova C, Celli BR, Barria P, Casas A, Cote C, de Torres JP, Jardim J, Lopez MV, Marin JM, Montes de Oca M, Pinto-Plata V, Aguirre-Jaime A; Six Minute Walk Distance Project (ALAT). The 6-min walk distance in healthy subjects: reference standards from seven countries. Eur Respir J. 2011 Jan;37(1):150-6. doi: 10.1183/09031936.00194909. Epub 2010 Jun 4.

  PMID: 20525717 BACKGROUND

• Ekstrom M, Li PZ, Lewthwaite H, Bourbeau J, Tan WC, Jensen D. The modified Borg/6-min walk distance ratio: a method to assess exertional breathlessness and leg discomfort using the 6-min walk test. ERJ Open Res. 2023 Sep 25;9(5):00281-2023. doi: 10.1183/23120541.00281-2023. eCollection 2023 Sep.

  PMID: 37753276 BACKGROUND

• Burns DM. Epidemiology of smoking-induced cardiovascular disease. Prog Cardiovasc Dis. 2003 Jul-Aug;46(1):11-29. doi: 10.1016/s0033-0620(03)00079-3.

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• Hunt AR, Stuart CM, Gergen AK, Bang TJ, Reihman AE, Helmkamp LJ, Lin Y, Mitchell JD, Meguid RA, Scott CD, Wojcik BM. Long-Term Patient-Reported Symptom Improvement and Quality of Life after Transthoracic Diaphragm Plication in Adults. J Am Coll Surg. 2023 Sep 1;237(3):533-544. doi: 10.1097/XCS.0000000000000762. Epub 2023 May 17.

  PMID: 37194947 BACKGROUND

• Le UT, Titze L, Hundeshagen P, Passlick B, Schmid S. Robotic diaphragm plication: functional and surgical outcomes of a single-center experience. Surg Endosc. 2023 Jun;37(6):4795-4802. doi: 10.1007/s00464-023-09942-7. Epub 2023 Mar 13.

  PMID: 36914782 BACKGROUND

• Lampridis S, Pradeep IHDS, Bille A. Robotic-assisted diaphragmatic plication: Improving safety and effectiveness in the treatment of diaphragmatic paralysis. Int J Med Robot. 2022 Jun;18(3):e2368. doi: 10.1002/rcs.2368. Epub 2022 Jan 24.

  PMID: 35041770 BACKGROUND

• Valenti J, Tan K, Rubino K, Hanhan Z, Vega D, Kaufman M, Bauer T. Quality-of-life impact of diaphragm plication in patients with diaphragmatic paralysis: A retrospective study. Ann Thorac Med. 2024 Jan-Mar;19(1):105-111. doi: 10.4103/atm.atm_158_23. Epub 2024 Jan 25.

  PMID: 38444988 BACKGROUND

• Zwischenberger BA, Kister N, Zwischenberger JB, Martin JT. Laparoscopic Robot-Assisted Diaphragm Plication. Ann Thorac Surg. 2016 Jan;101(1):369-71. doi: 10.1016/j.athoracsur.2015.05.118.

  PMID: 26694286 BACKGROUND

• Kosse NJ, Galetin T, Schwarz SB, Mathes T, Koryllos A, Lopez-Pastorini A, Beckers F, Stoelben E. Results of the Diaphragmatic Plication Database: 10 Years' Experience. Thorac Cardiovasc Surg. 2023 Sep;71(6):483-489. doi: 10.1055/s-0041-1735496. Epub 2021 Oct 15.

  PMID: 34655069 BACKGROUND

• Freeman RK, Van Woerkom J, Vyverberg A, Ascioti AJ. Long-term follow-up of the functional and physiologic results of diaphragm plication in adults with unilateral diaphragm paralysis. Ann Thorac Surg. 2009 Oct;88(4):1112-7. doi: 10.1016/j.athoracsur.2009.05.027.

  PMID: 19766791 BACKGROUND

• Beshay M, Abdel Bary M, Kosek V, Vordemvenne T, Mertzlufft F, Schulte Am Esch J. Minimally-Invasive Diaphragmatic Plication in Patients with Unilateral Diaphragmatic Paralysis. J Clin Med. 2023 Aug 15;12(16):5301. doi: 10.3390/jcm12165301.

  PMID: 37629343 BACKGROUND

• Gharagozloo F, McReynolds SD, Snyder L. Thoracoscopic plication of the diaphragm. Surg Endosc. 1995 Nov;9(11):1204-6. doi: 10.1007/BF00210929.

  PMID: 8553235 BACKGROUND

• Freeman RK, Wozniak TC, Fitzgerald EB. Functional and physiologic results of video-assisted thoracoscopic diaphragm plication in adult patients with unilateral diaphragm paralysis. Ann Thorac Surg. 2006 May;81(5):1853-7; discussion 1857. doi: 10.1016/j.athoracsur.2005.11.068.

  PMID: 16631685 BACKGROUND

• Gazala S, Hunt I, Bedard EL. Diaphragmatic plication offers functional improvement in dyspnoea and better pulmonary function with low morbidity. Interact Cardiovasc Thorac Surg. 2012 Sep;15(3):505-8. doi: 10.1093/icvts/ivs238. Epub 2012 Jun 12.

  PMID: 22691375 BACKGROUND

Related Links

• Brief information about the study on Swedish Respiratory Society´s website

MeSH Terms

Conditions

Respiratory Paralysis; Diaphragmatic Eventration; Dyspnea

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Abnormalities; Digestive System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory

Study Officials

• Andreas Palm, Md, PhD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Palm, MD, PhD

CONTACT

+46 70 3573595; andreas.palm@medsci.uu.se

Marie Mannberg, Research nurse

CONTACT

+46 18 611 40 68; marie.mannberg@uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 9, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)