Ambulatory Laparoscopic Inguinal Hernioplasty: Feasibility and Cost Analysis

NCT04504461 | Completed

• 1 other identifier: 5614
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic inguinal hernia repair has become one of the elective techniques, attributing the advantages of minimally invasive procedures to it. However, the high costs related to the need for hospitalization and materials make them a limitation at the time of its indication. The objective is to evaluate the feasibility of performing this procedure in an outpatient surgery center and the cost analysis of an outpatient procedure regarding the same in the setting of hospitalization.

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (2)

• Incidence of surgical Complications

  Incidence of seroma, Incidence of hematoma, % of reoperation, incidence of wound infection

  Patients follow up is 12 month

• Costs of the procedure

  Cost of laparoscopic hernioplasty in ambulatory surgery center. Cost of laparoscopic hernioplasty when required hospital stay

  One month after surgery

Study Arms (2)

Laparoscopic Inguinal Hernioplasty. Ambulatory

Laparoscopic Inguinal Hernioplasty performed in ambulatory surgery center

Other: Analysis of feasibility and costs

Laparoscopic Inguinal Hernioplasty. Hospital Stay

Laparoscopic Inguinal Hernioplasty that have to stay at least 24 hours at the hospital

Other: Analysis of feasibility and costs

Interventions

Analysis of feasibility and costs OTHER

Analyze the feasibility and costs of performing laparoscopic inguinal hernioplasty in an ambulatory surgery center

Laparoscopic Inguinal Hernioplasty. Ambulatory; Laparoscopic Inguinal Hernioplasty. Hospital Stay

Eligibility Criteria

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

Study Population

Patients older than 18 with no major comorbidities that required a laparoscopic inguinal hernioplasty

You may qualify if:

• Patients older than 18 years old
• Laparoscopic inguinal hernioplasty as the pincipal surgery

You may not qualify if:

• Patients with, high anesthetic risk (decompensated ASA III and ASA IV)
• Morbid obesity (higher BMI 40),
• Sleep apnea with indication of use of CPAP (Continuous Positive Airway Pressure)
• Medicated psychiatric disease,
• Drug-dependent patient
• Patients with an inadequate social environment-

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Ciudad de Buenos Aires, 1199, Argentina

Location

Related Publications (6)

• Jenkins JT, O'Dwyer PJ. Inguinal hernias. BMJ. 2008 Feb 2;336(7638):269-72. doi: 10.1136/bmj.39450.428275.AD. No abstract available.

  PMID: 18244999 BACKGROUND

• Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R Jr, Dunlop D, Gibbs J, Reda D, Henderson W; Veterans Affairs Cooperative Studies Program 456 Investigators. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med. 2004 Apr 29;350(18):1819-27. doi: 10.1056/NEJMoa040093. Epub 2004 Apr 25.

  PMID: 15107485 BACKGROUND

• Payne JH Jr, Grininger LM, Izawa MT, Podoll EF, Lindahl PJ, Balfour J. Laparoscopic or open inguinal herniorrhaphy? A randomized prospective trial. Arch Surg. 1994 Sep;129(9):973-9; discussion 979-81. doi: 10.1001/archsurg.1994.01420330087016.

  PMID: 8080380 BACKGROUND

• Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2009 Aug;13(4):343-403. doi: 10.1007/s10029-009-0529-7. Epub 2009 Jul 28.

  PMID: 19636493 BACKGROUND

• Miserez M, Peeters E, Aufenacker T, Bouillot JL, Campanelli G, Conze J, Fortelny R, Heikkinen T, Jorgensen LN, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Simons MP. Update with level 1 studies of the European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2014 Apr;18(2):151-63. doi: 10.1007/s10029-014-1236-6. Epub 2014 Mar 20.

  PMID: 24647885 BACKGROUND

• McCloud JM, Evans DS. Day-case laparoscopic hernia repair in a single unit. Surg Endosc. 2003 Mar;17(3):491-3. doi: 10.1007/s00464-002-9093-2. Epub 2002 Nov 6.

  PMID: 12415338 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Costs and Cost Analysis

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Officials

• Scaravonati

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 7, 2020
• Study Start: August 1, 2015
• Primary Completion: June 30, 2018
• Study Completion: July 30, 2019
• Last Updated: December 1, 2020

Record last verified: 2020-08

Locations

AR (1)