ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment

HERNIA, VENTRAL Clinical Trial

— ProLOVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472537
• Other study ID #: LU030123PR
• Secondary ID: 200-06-005
• Status: Completed
• Phase: N/A
• First received: May 10, 2007
• Last updated: April 22, 2013
• Start date: November 2005
• Est. completion date: November 2010

Study information

• Verified date: April 2013
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Swedish National Council on Medical EthicsSweden: The National Board of Health and Welfare
• Study type: Observational

Clinical 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. Focus is on the recovery phase assuming a less painful recovery after a laparoscopic procedure.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral

Intervention

Procedure:
• Retromuscular Mesh repair of midline incisional hernia

• Laparoscopic repair of midline incisional hernia

Locations

Country	Name	City	State
Sweden	Arvika Hospital, Department of Surgery	Arvika
Sweden	Helsingborg Hospital, Department of Surgery	Helsingborg
Sweden	Lund University Hospital, Department of Surgery	Lund
Sweden	Malmö University Hospital, Department of Surgery	Malmö
Sweden	Mora Hospital, Department of Surgery	Mora
Sweden	Södertälje Hospital, Department of Surgery	Sodertalje
Sweden	Västerås Central Hospital, Department of Surgery	Vasteras

Sponsors (7)

Lead Sponsor	Collaborator
Skane University Hospital	Crafoord Foundation, Ethicon, Inc., Lund University, Region Skåne FoUU, The Anna-Lisa & Sven-Eric Lundgren Foundation, Malmö Sweden, The Einar & Inga Nilsson Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain recorded in SF-36	Pain measured 3 weeks after surgery in SF36 subscale Bodily Pain	3 weeks after surgery	No