Clinical trial NCT00472537: ProLOVE - Prospective Randomized Study of Midline Incisional Hernia Treatment
Official title: Prospective Randomized Evaluation of Open vs. Laparoscopic Operation of Ventral Incisional Eventrations. A Swedish Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HERNIA, VENTRAL
Keywords: Ventral hernia
Incisional hernia
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Region Skåne FoUU
name: Lund University
name: Ethicon, Inc.
name: The Einar & Inga Nilsson Foundation
name: The Anna-Lisa & Sven-Eric Lundgren Foundation, Malmö Sweden
name: Crafoord Foundation
First posted: 2007-05-11
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients referred to specialist centers for treatment of midline incisional hernias.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain recorded in SF-36
timeFrame: 3 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Arvika
country: Sweden
facility: Arvika Hospital, Department of Surgery
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital, Department of Surgery
city: Lund
country: Sweden
facility: Lund University Hospital, Department of Surgery
city: Malmö
country: Sweden
facility: Malmö University Hospital, Department of Surgery
city: Mora
country: Sweden
facility: Mora Hospital, Department of Surgery
city: Sodertalje
country: Sweden
facility: Södertälje Hospital, Department of Surgery
city: Vasteras
country: Sweden
facility: Västerås Central Hospital, Department of Surgery
Study officials:
affiliation: Malmo University Hospital, Lund University
name: Agneta Montgomery, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.