Pain and Convalescence After Laparoscopic Groin Hernia Repair

NCT00962338 | Completed DMC

• 1 other identifier: SJ-125
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia; Convalescence

Keywords

convalescence; pain; nausea; vomiting; sexual dysfunction

Outcome Measures

Primary Outcomes (1)

• duration of convalescence

  3 weeks in average

Secondary Outcomes (9)

• Pain scores on visual analog scale and verbal rating scale

  6 months

• fatigue scores on numeric rating scale (1-10)

  6 months

• sexual dysfunction

  6 months

• nausea scores on verbal rating scale

  3 days

• vomiting

  3 days

Study Arms (1)

lap. inguinal herniorrhaphy

Patients undergoing planned lap. inguinal herniorrhaphy

Behavioral: Information

Interventions

Information BEHAVIORAL

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

Also known as: Groin hernia repair, TAPP, Convalescence

lap. inguinal herniorrhaphy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population are from Region Sjaelland and are planned for laparoscopic inguinal or femoral herniorrhaphy. Single university hospital department i Denmark.

You may qualify if:

• planned laparoscopic inguinal or femoral herniorrhaphy
• ASA class I-II
• speak and read danish

You may not qualify if:

• converting to open operation
• low compliance (dementia, psychiatric disorder)
• use of morphine or similar drugs daily in the last month
• complications to the operation

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

University Hospital Køge

Koege, Region Sjælland, 4600, Denmark

Location

Related Publications (2)

• Tolver MA, Rosenberg J. Pain during sexual activity before and after laparoscopic inguinal hernia repair. Surg Endosc. 2015 Dec;29(12):3722-5. doi: 10.1007/s00464-015-4143-8. Epub 2015 Mar 18.

  PMID: 25783834 DERIVED

• Tolver MA, Strandfelt P, Rosenberg J, Bisgaard T. Female gender is a risk factor for pain, discomfort, and fatigue after laparoscopic groin hernia repair. Hernia. 2013 Jun;17(3):321-7. doi: 10.1007/s10029-012-0956-8. Epub 2012 Jul 12.

  PMID: 22790511 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal; Convalescence; Pain; Nausea; Vomiting; Sexual Dysfunction, Physiological

Interventions

tetra-4-amidinophenoxypropane

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive; Genital Diseases; Urogenital Diseases

Study Officials

• Mette A Tolver, M.D.

  University Hospital Køge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 20, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

DK (1)