Pain and Convalescence After Laparoscopic Groin Hernia Repair

Completed

• Conditions: Convalescence; Inguinal Hernia
• Interventions: Behavioral: Information

• Registration Number: NCT00962338
• Lead Sponsor: Zealand University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-19
• Study First Posted: 2009-08-20
• Primary Completion: 2010-12
• Study Completion: 2011-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
lap. inguinal herniorrhaphy	Information	Patients undergoing planned lap. inguinal herniorrhaphy

Primary Outcome Measures

Name	Time	Method
duration of convalescence	3 weeks in average

Secondary Outcome Measures

Name	Time	Method
fatigue scores on numeric rating scale (1-10)	6 months	daily first 4 days, 1 and 6 months
Pain scores on visual analog scale and verbal rating scale	6 months	daily first 4 days, after 1 and 6 months
nausea scores on verbal rating scale	3 days
Pain catastrophizing scale (PCS)	Baseline (before operation)
sexual dysfunction	6 months
vomiting	3 days
wellbeing scores on visual analog scale	6 months
Activity assessment scale (AAS)	Baseline (before operation)	Functional status
Hospital anxiety and depression scale (HAD)	Baseline (before operation)

Trial Locations

Locations (1)

University Hospital Køge; 🇩🇰 Koege, Region Sjaelland, Denmark