A systematic methodological review of reported perioperative variables, postoperative outcomes and hernia recurrence from randomised controlled trials of elective ventral hernia repair: clear definitions and standardised datasets are needed
This systematic review assesses the perioperative variables and post-operative outcomes reported by randomised controlled trials (RCTs) of VH repair. This review focuses particularly on definitions of hernia recurrence and techniques used for detection.
Our aim is to identify and quantify the inconsistencies in perioperative variable and postoperative outcome reporting, so as to justify future development of clear definitions of hernia recurrence and a standardised dataset of such variables.
The PubMed database was searched for elective VH repair RCTs reported January 1995 to March 2016 inclusive. Three independent reviewers performed article screening, and two reviewers independently extracted data. Hernia recurrence, recurrence rate, timing and definitions of recurrence, and techniques used to detect recurrence were extracted. We also assessed reported post-operative complications, standardised operative outcomes, patient reported outcomes, pre-operative CT scan hernia dimensions, intra-operative variables, patient co-morbidity, and hernia morphology.
31 RCTs (3367 patients) were identified. Only 6 (19.3%) defined hernia recurrence and methods to detect recurrence were inconsistent. Sixty-four different clinical outcomes were reported across the RCTs, with wound infection (30 trials, 96.7%), hernia recurrence (30, 96.7%), seroma (29, 93.5%), length of hospital stay (22, 71%) and haematoma (21, 67.7%) reported most frequently. Fourteen (45%), 11 (35%) and 0 trials reported CT measurements of hernia defect area, width and loss of domain, respectively. No trial graded hernias using generally accepted scales.
VH RCTs report peri- and post-operative variables inconsistently, and with poor definitions. A standardised minimum dataset, including definitions of recurrence, is required.
KeywordsVentral hernia Abdominal wall reconstruction Standardisation
This work was supported by the United Kingdom National Institute for Health Research (NIHR) via Research for Patient Benefit grant PB-PG-0816-20005 and the University College London Hospitals Biomedical Research Centre (SH). The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
Compliance with ethical standards
Conflict of interest
Windsor A.C.J. declares conflicts of interest not directly related to the submitted work; educational grants and speaker for: BARD, LifeCell and Cook. Parker S.G, Wood C.P.J, Butterworth J.W, Boulton R.W, Plumb A.A.O, Mallet S and Halligan S declare no conflict of interest.
Ethical permission is not required by our centre for systematic reviews of available primary literature.
Human and animal participants
This article does not contain any studies with human participants performed by any of the authors.
This article does not include patients, and therefore informed consent was not applicable.
- 2.The Royal College of Physicians (2004) Royal College of Paediatrics and Child Health and Faculty of Public Health. Storing up problems: the medical case for a slimmer nation. Report of a working party. RCPCH and Faculty of Public Health. RCP, LondonGoogle Scholar
- 4.Dabbas N, Adams K, Pearson K, Royle GT (2011) Frequency of abdominal wall hernias: is classical teaching out of date? J R Soc Med 2(1):1–6Google Scholar
- 13.OCEBM Levels of Evidence Working Group (2011) The Oxford levels of evidence 2. Oxford cent evidence-based med. www.cebm.net/index.aspx?o=5653. (Internet)
- 19.Dietz UA, Hamelmann W, Winkler MS, Debus ES, Malafaia O, Czeczko NG et al (2007) An alternative classification of incisional hernias enlisting morphology, body type and risk factors in the assessment of prognosis and tailoring of surgical technique. J Plast Reconstr Aesthetic Surg 60:383–388CrossRefGoogle Scholar
- 29.Eker HH, Hansson BME, Buunen M, Janssen IMC, Pierik REGJM, Hop WC et al (2013) Laparoscopic vs open incisional hernia repair a randomized clinical trial. Jama 148(3):259–63Google Scholar
- 40.Lal K, Laghari ZH, Laghari AA, Soomro E (2012) A comparative study of anatomical repair versus mesh repair in paraumbilical hernia. Med Channel. 19(2):110–114Google Scholar
- 41.Bansal VK, Misra MC, Babu D, Singhal P, Rao K, Sagar R et al (2012) Comparison of long-term outcome and quality of life after laparoscopic repair of incisional and VHs with suture fixation with and without tacks: a prospective, randomized, controlled study. Surg Endosc 26:3476–3485PubMedCrossRefGoogle Scholar
- 51.Rickert A, Kienle P, Kuthe A, Baumann P, Engemann R, Kuhlgatz J et al (2012) A randomised, multi-centre, prospective, observer and patient blind study to evaluate a non-absorbable polypropylene mesh vs. a partly absorbable mesh in incisional hernia repair. Langenbecks Arch Surg 397:1225–1234PubMedPubMedCentralCrossRefGoogle Scholar
- 59.Ware JE, Snow KK, Kosinski M, Gandek B (1993) SF-36 Health survey: manual and interpretation guide. New England Medical Center, BostonGoogle Scholar