Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease

NCT01575314 | Completed DMC

• 1 other identifier: SUR-11-09-26A-13-X
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy and cost difference of using a parenchymal stapling device versus hand sewing for a pulmonary lobectomy in patients with lung disease (mass or others).

Conditions

Malignant Neoplasm of Bronchus or Lung, Unspecified

Keywords

stapling device; lobectomy; cost utility

Outcome Measures

Primary Outcomes (1)

• Post-operative air leak, operative time, and duration of air leak

  To compare post-operative air leakage between two groups. This data will be analyzed by fisher exact probability test. We will start observation of the air leakage at postoperative day 1. The stoping role is when statistically significant difference occur. We will measure and report in the number of patients who have post-operative air leakage.

  In the operative day, after surgery, until patient can be discharged.

Secondary Outcomes (3)

• cost of treatment

  within the time that patient admit in the hospital

• Re-operation due to postoperative air leakage

  8 month after recording data

• Length of Hospital stay

  8 month after recording data

Study Arms (2)

stapling device

EXPERIMENTAL

stapling device refer to patients who were randomized to use stapler for dividing lung parenchyma.

Device: stapling device

hand sewn

NO INTERVENTION

hand sewn refer to patients who were randomized to use hand suturing for dividing lung parenchyma.

Interventions

stapling device DEVICE

Stapling device include GIA 80, TA 45, endo GIA 60, endo GIA 45

Also known as: stapler

stapling device

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who diagnosed lung diseases that need to perform pulmonary lobectomy

You may not qualify if:

• Patients have complete fissure. therefore, no procedure need to divide the lung parenchyma.

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Department of surgery, Faculty of medicine, Chiang Mai University Hospital

Amphoe Meung, Chaing Mai, 50200, Thailand

Location

Related Publications (2)

• Moggi L, Giustozzi GM, Cagini L, Boselli C. [Surgical staplers in thoracic surgery]. G Chir. 1992 Apr;13(4):177-9. Italian.

  PMID: 1637625 RESULT

• Tantraworasin A, Seateang S, Bunchungmongkol N. Staplers versus hand-sewing for pulmonary lobectomy: randomized controlled trial. Asian Cardiovasc Thorac Ann. 2014 Mar;22(3):309-14. doi: 10.1177/0218492313491754. Epub 2013 Aug 19.

  PMID: 24585907 DERIVED

Related Links

• Click here for more information about this study

MeSH Terms

Interventions

Surgical Staplers

Intervention Hierarchy (Ancestors)

Surgical Instruments; Surgical Equipment; Equipment and Supplies

Study Officials

• Apichat Tantraworasin, M.D.

  Department of Surgery, Faculty of medicine, Chiang mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General thoracic surgery unit, Department of Surgery, Faculty of Medicine, Chiang Mai University Hospital

Study Record Dates

• First Submitted: April 6, 2012
• First Posted: April 11, 2012
• Study Start: November 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: July 1, 2013
• Last Updated: February 2, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)