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HERNIA, VENTRALProLOVENCT00472537

ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment

An observational study of HERNIA, VENTRAL, run by Skane University Hospital at 7 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HERNIA, VENTRAL
What is being tested?
Retromuscular Mesh repair of midline incisional hernia and Laparoscopic repair of midline incisional hernia
Type of treatment
Surgery or procedure
How many people
157 participants
Where
7 sitesSweden
Study dates
Nov 2005to Nov 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Sweden7 sites

  • Arvika Hospital, Department of Surgery

    Arvika, SE-671 80

  • Helsingborg Hospital, Department of Surgery

    Helsingborg, 251 87

  • Lund University Hospital, Department of Surgery

    Lund, SE-222 41

  • Malmö University Hospital, Department of Surgery

    Malmö, Malmö, 20502

  • Mora Hospital, Department of Surgery

    Mora, SE-792 85

  • Södertälje Hospital, Department of Surgery

    Södertälje, SE-152 86

  • Västerås Central Hospital, Department of Surgery

    Västerås, SE-721 89

Other trials in Sweden

About this study

Official title: Prospective Randomized Evaluation of Open vs. Laparoscopic Operation of Ventral Incisional Eventrations. A Swedish Multicenter Study

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.

Read the detailed description

Incisional ventral hernia after abdominal surgery is a fairly common condition. In recent years the use of a prosthesis in the repair procedure has proved very effective in preventing a new hernia. A retromuscular mesh placement seems to have superior results. The mesh may be placed retromuscular through an open surgical procedure or through a laparoscopic procedure in an intra-abdominal position. Both procedures are highly standardized. A heavy weight mesh is used in the open procedure, fixed in the midline only, and a composite mesh is used intraabdominally and fixed only with titanium tackers.

SF-36 is used to assess the quality of life, and its subscale BP (bodily pain) is used as primary outcome 3 weeks postoperatively. Secondary endpoints are return to daily life, pain, complications, recurrence, patient satisfaction and cosmetic outcome.

Subjects are assessed at 1,3,8 weeks post operation and after 12 months.

Conditions
HERNIA, VENTRAL
Being tested
Retromuscular Mesh repair of midline incisional hernia, Laparoscopic repair of midline incisional hernia
Keywords
Ventral hernia, Incisional hernia
Medical subject headings
Hernia, Ventral, Incisional Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Retromuscular Mesh repair of midline incisional herniaProcedure or surgery

  • Laparoscopic repair of midline incisional herniaProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pain recorded in SF-36

    Pain measured 3 weeks after surgery in SF36 subscale Bodily Pain

    Measured: 3 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2007 (estimated)
  2. Study startNov 2005
  3. Primary completionNov 2010
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
157 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00472537
Sponsor's protocol ID
LU030123PR
Other IDs
200-06-005
Acronym
ProLOVE
Status last verified
Apr 2013
First submitted
10 May 2007
Last updated
24 Apr 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28634690

  • 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.

    PubMed 23629524

Questions about this trial

What is this clinical trial studying?

An observational study of HERNIA, VENTRAL, run by Skane University Hospital at 7 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain recorded in SF-36 (time frame: 3 weeks after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00472537, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2013.

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