Inguinal Hernia: Future Directions Brian Jacob MD FACS New York, NY

Peter Drucker “The only thing we know about the future is that it will be different.” November 1909 – November 2005. Influential author, businessman

Inguinal Hernia Repairs: innovation Access Mesh Fixation Patient Satisfaction Techniques

Evolution of Inguinal Hernia: Access Techniques 1559 - 1989 1990-2008 2009 --- Open Stromayr 1559 Lucas-Championnière 1881 Bassini 1889 McVay 1942 Shouldice 1945 Lichtenstein 1987 Stoppa 1989 Laparoscopic Ger 1990 Velez and Klein 1990 Others SILS / NOTES Just now being described Sachs M, Damm M, Encke A. 1997. World J Surg. 218-223

Early Inguinal Hernia Repairs 1559 Caspar Stromayr. Practica Copiosa. Great Ideas in the History of Surgery By Leo M. Zimmerman, Ilza Veith

Early Inguinal Hernia Repairs 1559 Caspar Stromayr. Practica Copiosa. Great Ideas in the History of Surgery By Leo M. Zimmerman, Ilza Veith

Inguinal Hernia: Emerging Technologies Single Port Inguinal Ventral NOTES Transgastric Transvaginal

Inguinal Hernia: Emerging Technologies Single Port Inguinal Ventral NOTES Transgastric Transvaginal Indications

Inguinal Hernia: Emerging Technologies Single Port Inguinal Ventral NOTES Transgastric Transvaginal

Worse Options:

Single Incision Laparoscopic Surgery (SILSTM ): Introduction Descriptions as early as 1996 Synonyms SPA LESS Others Rapid growth since 2007

Single Incision Laparoscopic Surgery (SILSTM ): Introduction Rapid growth since 2007 Growth precedes proven clinical benefits

Single Incision Laparoscopic Surgery (SILSTM ): Introduction Rapid growth since 2007 Growth precedes proven clinical benefits Demonstrated feasibility in multiple specialties General, Colorectal, Bariatrics, Urologic, and Gynecologic

Single Incision Laparoscopic Surgery: Many variations on a single theme Skin incision Location and size

Single Incision Laparoscopic Surgery: Many variations on a single theme Skin incision Location and size Entry method Multiple trocars or single port access device

Single Incision Laparoscopic Surgery: Many variations on a single theme Skin incision Location and size Entry method Multiple trocars or single port access device Instrumentation / Scopes

Single Incision Laparoscopic Surgery: Many variations on a single theme Skin incision Location and size Entry method Multiple trocars or single port access device Instrumentation / Scopes Retraction

SILSTM Inguinal Hernia: Introduction SILSTM TEP Filipovic-Cugura J, Kirac I, Kulis T, Jankovic J, Bekavac-Beslin M (Surg Endosc April 2009) (Croatia) (routine) Jacob BP, Tong W, Katz B, Vine A, Reiner M (Hernia June 2009) (USA) (SILSTM Port) Agrawal S, Shaw A, Soon Y (Surg Endosc Sept 2009) (UK) (TriPort) SILSTM TAPP Kroh M, Rosenblatt S (J Lap Adv Surg Tech A. April 2009) (USA) (Uni-X Single Port System) Rahman SH, John BJ (Hernia. Aug 2009) (UK) (roticulating graspers) Menenakos C, Kilian M, Hartmann J (Hernia. Aug 2009) (Germany) (TriPort) Source: pubmed.gov as of October 5, 2009 (“single incision hernia”)

Question: What (if anything) is wrong with the current standard?

Answer: Potentially only cosmesis

Early Experience: TEP Animal labs 2 – 3mm instruments Still needed at least one 5 mm Moved to 2 incision technique Moved to single incision with multiple trocars Sword fighting Air leaking Single port access device Feb 2009

Hernia. June 2009

Hernia. June 2009

Hernia. June 2009

Hernia. June 2009

SILSTM TEP: bilateral inguinal hernia repair 2 week follow-up 25 mm skin incision

SILSTM TEP: bilateral inguinal hernia repair 1 month follow-up 25 mm skin incision

SILSTM TEP: bilateral inguinal hernia repair 1 month follow-up 25 mm skin incision

SILSTM TEP: bilateral inguinal hernia repair immediate post operative

SILSTM TEP: don’t celebrate too early

SILSTM TEP hernia: initial experience with a single access port 8 men with bilateral indirect hernias One also with an umbilical hernia 1 man with unilateral indirect 1 woman with b/l direct and femoral hernia 2 converted to traditional 3 trocars Peritoneum violated Inability to reduce an adherent indirect

SILS TEP hernia: initial experience with a single access port Mean follow-up 8 months Incisional pain (1 - 6 days) Narcotics used for 0 – 4 days No early recurrences (up to 8 months) No incisional hernias so far Open umbilical hernia patient developed seroma

Early lessons learned Challenges Port insertion has a learning curve

Early lessons learned Challenges Learning curves all over again

Early lessons learned Challenges Many ports available Are they needed at all? Is one better than another?

Early lessons learned Challenges Many ports available Are they needed at all? Is one better than another? First trocar is blunt, but blind

Early lessons learned Challenges Many ports available Are they needed at all? Is one better than another? First trocar is blunt, but blind Incision size Port modifications ARE needed

Early lessons learned Unknown outcomes Seromas ? Incisional Hernias ? Costs ? Let’s be realistic ?

SILSTM Inguinal Hernia: conclusions SILSTM TEP, TAPP, IPOM techniques now being described (feasible) With and without single port access (SPA) devices Can be performed with same instruments in use today (may limit additional costs) Patients seem to like the single incision concept Experiences are only in the beginning stages Future is unknown Growth seems inevitable

Inguinal Hernia Repairs: innovation Access Mesh Fixation Patient Satisfaction Techniques

Randomized prospective Study of TEP: Fixation vs No Fixation of Mesh Jan 2002 – Jan 2004 40 males underwent lap TEP followed for one year using 10-point VAS for pain followed for a mean of 9 months (n=20) Heavyweight (100 g/m2) (Prolene) WITH TACKS (n=20) Heavyweight (108 g/ m2) (Davol 3DM) WITHOUT fixation No significant difference in post op pain (p=0.15) No significant difference in recurrent rates Did see more urinary retention in group where tacks were used Koch CA, Greenlee SM, Larson D, Harrington JR, Farley DR. JSLS. 2006. (Mayo, Minnesota)

Randomized prospective Study of TEP: Fixation vs No Fixation of Mesh Conclusions Use of tacks did not add pain (Is study under powered?) Avoiding tacks did not change recurrence rates Avoiding tacks can reduce costs, but keep outcomes the same Koch CA, Greenlee SM, Larson D, Harrington JR, Farley DR. JSLS. 2006. (Mayo, Minnesota)

Laparoscopic inguinal hernia repair without mesh fixation, early results of a large randomized clinical trial Dec 2004 and Jan 2006 360 males underwent lap TEP (500 hernias) followed for a mean of 8.2 months. Pain scale used at office visit Heavyweight (100 g/m2) (Prolene) WITH TACKS Heavyweight (100 g/ m2) (Prolene) WITHOUT TACKS WITH TACKS group had more new pain complaints (p=0.0003) No significant difference in recurrent rates Defect size all less than 2 cm For bilateral patients, the NO TACK side was 5x more likely to be more comfortable Conclusion: tacks may increase pain, costs, and may not be necessary ? Better powered than the Mayo Clinic study Taylor C, Layani L, Liew V etal. Surg Endosc. 2008. (Australia)

Laparoscopic TEP with nonfixation of the mesh for 1,692 hernias 3 year retrospective study Followed for recurrences, pain at one month, seroma, and urinary retention Recurrence rate only 0.22% Less pain than a cohort of patients who received fixation Conclusions: TEP without mesh fixation does not increase recurrence rates and is associated with less pain, urinary retention at 4 weeks Garg P, Rajagopal M, Varghese V, Ismail M. 2008. Surg Endosc. (Punjab, India)

Novel Concepts: Materials Self Adhering Mesh Fibrin Glues Partially absorbing mesh fibers Absorbable Tacks Lightweight (40 g/m2) polypropylene coated with synthetic glue (adhesix)(cousin biotech, Fr) Polyvinylpyrrolidone and polyethylene glycol Disappears in 2 -3 days Porcine animal study Same incorporation as mesh with tacks Champault G etal. 2008 Hernia. (Paris, France)

Novel Concepts: Materials Self Adhering Mesh Fibrin Glues Partially absorbing mesh fibers Absorbable Tacks

Novel Concepts: Materials Self Adhering Mesh Fibrin Glues Partially absorbing mesh fibers Absorbable Tacks poly(glycolide-co-L-lactide) (PGLA). Stepped Wing Flat Wing

Want to entirely eliminate morbidity? Don’t operate New evidence to support watchful waiting until symptoms worsen without adverse events Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A randomized clinical trial. Fitzgibbons RJ etal. JAMA 2006. Observation or Operation for Patients with an Asymptomatic Inguinal Hernia: A randomized clinical trial. O’dwyer PJ etal. Annals Surg. 2006 Does delaying repair of an asymptomatic hernia have a penalty? Thompson JS etal. Am J Surg. 2008

Conclusions: inguinal hernia Laparoscopic TEP / TAPP Recurrence rates not different in highly experienced hands Chronic pain not sig different May have early advantages for bilateral and recurrent hernias Lightweight mesh product Less pain especially during first 3 months Quicker return to work / activity No difference in recurrence rates in experience hands Tack fixation may not be necessary if proper overlap of the myopectineal orifice is achieved Chronic neuropathic pain with early onset, that responds to nerve blockade (CRPS 2): Best predictable outcome for relief following neurectomy or meshectomy

Peter Drucker “The best way to predict the future is to create it.” November 1909 – November 2005. Influential author, businessman

Thank you bpjacob@gmail.com