NCT00472537

Brief Summary

This purpose of this study is to compare the recovery after an operation of an incisional hernia within the limits of the rectus muscles of the abdominal wall. The use of a mesh in the repair of a postoperative hernia is considered obligatory. Placement of a retromuscular mesh is done by open or laparoscopic surgery. Focus is on the recovery phase assuming a less painful recovery after a laparoscopic procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2005

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

April 24, 2013

Status Verified

April 1, 2013

Enrollment Period

5 years

First QC Date

May 10, 2007

Last Update Submit

April 22, 2013

Conditions

HERNIA, VENTRAL

Keywords

Ventral herniaIncisional hernia

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain recorded in SF-36

    Pain measured 3 weeks after surgery in SF36 subscale Bodily Pain

    3 weeks after surgery

Interventions

Retromuscular Mesh repair of midline incisional herniaPROCEDURE
Laparoscopic repair of midline incisional herniaPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients referred to specialist centers for treatment of midline incisional hernias.

You may qualify if:

  • Age over 18 years
  • Postoperative hernias in the region of the recti abdomini muscles with a defect of less than 10 cm transversal width
  • No contraindications to laparoscopic procedure
  • The patient should be able to adequate ventilation/respiration after reduction of hernia contents
  • Indications for elective surgery

You may not qualify if:

  • Pregnant women
  • Prior operation of abdominal hernia with mesh placement in the compartment of the rectus abdominus muscle (i.e. prior onlay mesh is acceptable)
  • Need of an interpreter
  • Current drug abuse, mental disorder or other condition which makes the patient incapable of postoperative follow up
  • Body Mass index (BMI) \>40
  • Other planned concurrent operation
  • Current oral steroid treatment, or other immune system modulating treatment
  • Incarcerated incisional hernias
  • Parastomal hernias
  • Prior history of open abdomen
  • Enterocutaneous fistula or cutaneous infection
  • Hepatic cirrhosis or ascites
  • Generalized malignancy
  • History of radiation treatment in the abdomen.
  • ASA \>III

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Malmö University Hospital, Department of Surgery

Malmo, Malmö, 20502, Sweden

Location

Arvika Hospital, Department of Surgery

Arvika, SE-671 80, Sweden

Location

Helsingborg Hospital, Department of Surgery

Helsingborg, 251 87, Sweden

Location

Lund University Hospital, Department of Surgery

Lund, SE-222 41, Sweden

Location

Mora Hospital, Department of Surgery

Mora, SE-792 85, Sweden

Location

Södertälje Hospital, Department of Surgery

Södertälje, SE-152 86, Sweden

Location

Västerås Central Hospital, Department of Surgery

Västerås, SE-721 89, Sweden

Location

Related Publications (2)

  • Rogmark P, Ekberg O, Montgomery A. Long-term retromuscular and intraperitoneal mesh size changes within a randomized controlled trial on incisional hernia repair, including a review of the literature. Hernia. 2017 Oct;21(5):687-696. doi: 10.1007/s10029-017-1624-9. Epub 2017 Jun 20.

    PMID: 28634690DERIVED

  • Rogmark P, Petersson U, Bringman S, Eklund A, Ezra E, Sevonius D, Smedberg S, Osterberg J, Montgomery A. Short-term outcomes for open and laparoscopic midline incisional hernia repair: a randomized multicenter controlled trial: the ProLOVE (prospective randomized trial on open versus laparoscopic operation of ventral eventrations) trial. Ann Surg. 2013 Jul;258(1):37-45. doi: 10.1097/SLA.0b013e31828fe1b2.

    PMID: 23629524DERIVED

MeSH Terms

Conditions

Hernia, VentralIncisional Hernia

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Agneta Montgomery, MD, PhD

    Malmo University Hospital, Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.,

Study Record Dates

First Submitted

May 10, 2007

First Posted

May 11, 2007

Study Start

November 1, 2005

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

April 24, 2013

Record last verified: 2013-04

Locations

SE(7)