Pain and Convalescence After Laparoscopic Groin Hernia Repair

Inguinal Hernia Clinical Trial

— Lap-Lyske  

Official title:

Pain and Convalescence After Laparoscopic Groin Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962338
• Other study ID #: SJ-125
• Status: Completed
• Phase: N/A
• First received: August 19, 2009
• Last updated: August 19, 2011
• Start date: August 2009
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: University Hospital Koge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

The investigators want to identify limiting factors for short convalescence after laparoscopic groin hernia repair. Before the operation patients are given intensive structured information about one day´s convalescence. Patients fill out questionnaire before operation about several clinically relevant parameters. This is also done first 3 days after operation and after 1 month and 6 months. The patients are seen for clinical control at 1 and 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• planned laparoscopic inguinal or femoral herniorrhaphy

• ASA class I-II

• speak and read danish

Exclusion Criteria:

• converting to open operation

• low compliance (dementia, psychiatric disorder)

• use of morphine or similar drugs daily in the last month

• complications to the operation

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Convalescence
• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Behavioral:
• Information
Information on short convalescence (1 day). Example: Operated today and getting started with normal activities again tomorrow.

Locations

Country	Name	City	State
Denmark	University Hospital Køge	Koege	Region Sjaelland

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Koge

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of convalescence		3 weeks in average	No
Secondary	Pain scores on visual analog scale and verbal rating scale	daily first 4 days, after 1 and 6 months	6 months	No
Secondary	fatigue scores on numeric rating scale (1-10)	daily first 4 days, 1 and 6 months	6 months	No
Secondary	sexual dysfunction		6 months	No
Secondary	nausea scores on verbal rating scale		3 days	No
Secondary	vomiting		3 days	No
Secondary	wellbeing scores on visual analog scale		6 months	No
Secondary	Hospital anxiety and depression scale (HAD)		Baseline (before operation)	No
Secondary	Pain catastrophizing scale (PCS)		Baseline (before operation)	No
Secondary	Activity assessment scale (AAS)	Functional status	Baseline (before operation)	No