Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263250
Status:
COMPLETED
Last Update Posted:
2013-07-01
First Post:
2005-12-06
Brief Title:
Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men
Sponsor:
Creighton University
Organization:
Creighton University
Study Overview
Official Title:
Watchful Waiting Versus Open Tension-free Repair of Inguinal Hernia in Asymptomatic or Minimally Symptomatic Men
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter clinical trial to compare pain physical function and other outcomes in men with asymptomatic or minimally symptomatic inguinal hernias randomly assigned to watchful waiting without an operation or a standard hernia repair with mesh We studied the safety of delaying operation
Detailed Description:
CONTEXT Many men with an inguinal hernia have minimal symptoms Whether deferring operation is safe and a good option for some patients has not been assessed
OBJECTIVE To compare pain and the Physical Component Score PCS of the SF-36 at two years in men with minimally symptomatic inguinal hernias randomized to watchful waiting WW or a standard tension-free hernia repair TFR
DESIGN SETTING AND PATIENTS Between January 1999 and December 2004 we conducted a multicenter trial of 720 men 364 WW 356 TFR who were followed for 2-45 years Men were excluded with hernia pain interfering with activities undetectable hernias infection American Society of Anesthesiologists Physical Status 3 recent difficulty in reducing the hernia
INTERVENTIONS Men assigned to WW were followed at 6 months and annually and watched for hernia symptoms Men assigned to operation received TFR and were followed at 3 and 6 months and annually
OBJECTIVE To compare pain and the Physical Component Score PCS of the SF-36 at two years in men with minimally symptomatic inguinal hernias randomized to watchful waiting WW or a standard tension-free hernia repair TFR
DESIGN SETTING AND PATIENTS Between January 1999 and December 2004 we conducted a multicenter trial of 720 men 364 WW 356 TFR who were followed for 2-45 years Men were excluded with hernia pain interfering with activities undetectable hernias infection American Society of Anesthesiologists Physical Status 3 recent difficulty in reducing the hernia
INTERVENTIONS Men assigned to WW were followed at 6 months and annually and watched for hernia symptoms Men assigned to operation received TFR and were followed at 3 and 6 months and annually
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None