Format

Send to

Choose Destination
Contemp Clin Trials Commun. 2016 Aug 11;4:118-123. doi: 10.1016/j.conctc.2016.08.001. eCollection 2016 Dec 15.

Development of an open prospective observational multicentre cohort study to determine the impact of standardization of laparoscopic intraperitoneal onlay mesh repair (IPOM) for incisional hernia on clinical outcome and quality of life (LIPOM-Trial).

Author information

1
Department of General and Visceral Surgery, Klinikum Fulda, Universitätsmedizin Marburg - Campus Fulda, Fulda, Germany.
2
Department of General, Vascular and Visceral Surgery, Klinik Kitzinger Land, Kitzingen, Germany.
3
Department of General, Thoracic and Visceral Surgery, Sozialstiftung Bamberg, Bamberg, Germany.
4
Department of General, Visceral and Transplantation Surgery, University of Tübingen, Tübingen, Germany.
5
StatConsult, Gesellschaft für klinische und Versorgungsforschung mbH, Magdeburg, Germany.
6
Department of General and Visceral Surgery, St. Elisabethen-Krankenhaus, Frankfurt a. M., Germany.

Abstract

Background:

Incisional hernias are one of the most frequent complications in abdominal surgery. Laparoscopic repair has been widely used since its first description but has not been standardized. A panel of hernia experts with expertise on the subject "incisional hernia" was established to review existing literature and define a standard approach to laparoscopic IPOM-repair for incisional hernia. All involved surgeons agreed to perform further IPOM-repairs of incisional hernia according to the protocol.

Methods/design:

This article summarizes the development of an open prospective observational multicentre cohort study to analyse the impact of a standardization of laparoscopic IPOM-repair for incisional hernia on clinical outcome and quality of life (health care research study).

Discussion:

Our literature search found that there is a lack of standardization in the surgical approach to incisional hernia and the use of medical devices. The possibility of different surgical techniques, various meshes and a variety of mesh fixation techniques means that the results on outcome after incisional hernia repair are often not comparable between different studies. We believe there is a need for standardization of the surgical procedure and the use of medical devices in order to make the results more comparable and eliminate confounding factors in interpreting the results of surgical hernia repair. This approach, in our view, will also illustrate the influence of the operative technique on the general quality of surgical treatment of incisional hernias better than a "highly selective" study and will indicate the "reality" of surgical treatment not only in specialist centres.

Trial registration:

The LIPOM-trial is registered at www.clinicaltrials.gov, with identifier: NCT02089958.

KEYWORDS:

ASA, American Society of Anesthesiologists; CCS, Carolina Comfort Scale; CDC, Center for Disease Control and Prevention; Clinical outcome; DSMB, Data safety Management Board; EHS, European Hernia Society; HP, Hernia Panel; IDEAL, Idea Development, Exploration, Assessment, Long-term Follow-up; IPOM, Intraperitoneal onlay mesh augmentation; LIPOM, Laparoscopic intraperitoneal onlay mesh augmentation; LIPOM-Trial; Laparoscopic incisional hernia repair; NRS, Numerical Rating Scale; Prospective observational multicentre cohort trial; Quality of life; TM, Trade mark; W, Width

Supplemental Content

Full text links

Icon for Elsevier Science Icon for PubMed Central
Loading ...
Support Center