1. Introduction. 2. Material and methods Methodology

Size: px

Start display at page:

Download "1. Introduction. 2. Material and methods Methodology"

Roger Cox
5 years ago
Views:

1 Clinical evaluation on 96 patients of the SWING-CONTACT meshes in the treatment of groin hernia: a new three-dimensional device with atraumatic grips on both sides 1. Introduction This data collection was set up within the framework of the Swing-Contact meshes, manufactured by THT (Textile Hi-Tec), post-marketing surveillance plan. It allows evaluating safety and performances of the Swing-Contact meshes used in the treatment of inguinal and femoral hernias and to consolidate the pre-marketing clinical data. The data obtained aim to update the clinical evaluation and thus to improve the risk management during the life cycle of the device. 2. Material and methods 2.1. Methodology It is a non-interventional scientific evaluation subjected and accepted by the French independent administrative authority (CNIL) according to the regulations in force. The data recorded were collected by means of a pre-established follow-up form. These data include demographic and peroperative data as well as the results of a short-term follow-up visit. We are reporting data on a group of 96 patients operated between November 2009 and December 2010 for an inguinal or femoral hernia in 3 sites (cf. Appendix 1). Page 1/ 13

2 2.2. Objectives The main objective is to evaluate the safety of the Swing-Contact meshes in their normal use by the collection of complications after surgery. The secondary objective is to evaluate the performances of the Swing-Contact meshes in their normal use by the collection of the recurrence rate and the clinical evolution of the patient Assessment criteria The assessment criteria are as follows: Main assessment criterion To assess the level of complication during the postoperative period in a short term follow-up. Secondary assessment criteria To assess the level of recurrence and reoperation during the postoperative period in a short term follow-up Medical device The Swing-Contact meshes consist of polyester multifilament impregnated with aliphatic polyurethane, poly(ether urethane), PEU. These implants have a three-dimensional «honeycomb» knitted structure. Meshes have atraumatic grips on both sides avoiding the use of any fixation system. One of the references of the range is an anatomical prosthesis including a visual reference mark facilitating his positioning. Implants are available in several sizes: 8x13, 9x13, 10x15, 15x15 and 15x20 (in cm). The anatomical reference exists either in 11x15cm or 12x16cm. Theses implants are used in laparoscopy or laparotomy as abdominal wall reinforcement meshes placed in extraperitoneal position for: - Inguinal and femoral hernias - Small incisional or ventral hernia - Recurrences. The anatomical reference is used under laparoscopy in groin hernia repair in the adult (inguinal and femoral hernias). The prosthesis is introduced by a trocar under endoscopy via a completely extraperitoneal approach (TEP) or the transabdominal preperitoneal approach (TAPP). These implants have several advantages: - Unique porous structure to favor quick tissue ingrowth and colonization. - Elasticity and excellent multidirectional mechanical properties close to human tissue. - Impregnation of the implant with poly(ether urethane) to increase the rigidity of the mesh. - Fixation free prosthesis with atraumatic grips on both sides who allow reducing postoperative pain. Page 2/ 13

Three references were used in this cases series: - CO3+ 0813 A, - CO3+ 1015 S, - CO3A 1216 D+/G+ and CO3A 1115 D+/G+, anatomical reference. 3.

3 Three references were used in this cases series: - CO A, - CO S, - CO3A 1216 D+/G+ and CO3A 1115 D+/G+, anatomical reference. 3. ANALYSIS Patients included in this clinical data collection were divided in 2 groups according to the surgical approach used: laparotomy or laparoscopy. The characteristics of each group and the results obtained are presented separately in this report. The population concerned corresponds to the major population requiring parietal reinforcement for groin hernia or small incisional or ventral hernia and not having the counter-indications described in the instructions for use Laparotomy group = Lichtenstein technique Patient characteristics The 39 patients included in the laparotomy group are aged between 27 and 81 years old (mean of 56 years) and are a majority of men (36 men and 3 women). The body mass index (BMI) was calculated for 36 patients: - 12 patients have a normal stoutness (BMI ranging between 18.5 and 25) - 19 patients, including 3 older than 65 years old, are in overweight (BMI ranging between 25 and 30) - 5 patients, including 1 older than 65 years old, have a moderate obesity (BMI ranging between 30 and 35). No patient (33 provided) exerts repeated physical efforts in their daily activity. Population repartition by age All included patients had an inguinal hernia: right inguinal hernia in 53.8% (21/39), left inguinal hernia in 43.6% (17/39), and bilateral inguinal hernia in 2.6% (1/39) of cases. Page 3/ 13

For 1 patient, it was a recurrence. Hernias localization 3.1.2. Surgery For the majority of cases (97.4%, 37/38 provided) a general anesthesia was practiced.

4 For 1 patient, it was a recurrence. Hernias localization Surgery For the majority of cases (97.4%, 37/38 provided) a general anesthesia was practiced. One patient had a loco-regional anesthesia. The surgery length is between 15 to 55 minutes (mean of 32 minutes). Intervention duration (in minutes) The patients who had unilateral hernia were treated by the installation of a single prosthesis and the patient who has bilateral hernia was treated by the installation of two prostheses. For all patients, the reference used was CO The patient who had a bilateral hernia was treated for one side with one CO A mesh and for the other side with a mesh in polyester of three-dimensional structure and impregnated of equine collagen (SC3, manufactured by THT, Textile Hi-Tec). All prostheses implanted had the same size: 8x13 cm. Page 4/ 13

5 All the 40 implanted prostheses in this patient group were fixed. According to the Lichtenstein procedure, 3 points of fixation were carried out in 2-0 prolene suture: 1 point to inguinal ligament and 2 points to internal oblique muscle. The hospitalization duration was between 1 to 6 days (mean of 3 days). Hospitalization duration (in days) Postoperative visit All patients were reviewed during a postoperative visit at 35 days on average (from 20 to 60 days). Time of follow-up visit (in days) 3.2. Laparoscopy group Patient characteristics The 57 patients included in the laparoscopy group are aged between 21 and 85 years old (mean of 57 years) and are men in majority (50 men and 7 women). Page 5/ 13

6 The body mass index (BMI) was calculated for the 57 patients: - 30 patients have a normal stoutness (BMI ranging between 18.5 and 25) - 23 patients, including 3 older than 65 years old, are in overweight (BMI ranging between 25 and 30) - 4 patients, including 1 aged of 66 years old, present a moderate obesity (BMI ranging between 30 and 35). Twenty (20) patients on 56 exert repeated physical efforts in their daily activity. Population repartition by age The surgery indications for the 56 patients of the group are the following: - Direct inguinal hernia (11 bilateral, 3 left, 3 right) in 17 patients - External oblique inguinal hernia (8 bilateral, 9 left, 10 right) in 27 patients - Femoral hernia (1 bilateral, 1 left) in 2 patients - Right scrotal inguinal hernia in 1 patient - Left external oblique scrotal inguinal hernia in 1 patient - External oblique scrotal inguinal hernia in 1 patient - Direct and external oblique inguinal hernia (1 bilateral, 1 left, 2 right) in 4 patients - Left external oblique inguinal hernia + left femoral hernia in 1 patient - Right direct and external oblique + left external oblique inguinal hernia in 1 patient - Left external oblique inguinal hernia + a recurrence of a right inguinal hernia in 1 patient - Right direct + left external oblique inguinal hernia in 1 patient In conclusion, the group includes 33 unilateral hernias including a total of 37 defects and 24 bilateral hernias including a total of 51 defects therefore a total of 88 defects for the entire group. The direct and external oblique inguinal hernias are characterize by the presence of 2 defects but are operated with a single mesh. This is the same for the inguinal hernia associated to the femoral hernia. Hernia size varied approximately from 0.5 to 20 mm for 86 defects: - 1 hernia size of 0.5 mm - 3 hernia size of 5 mm - 1 hernia size of 8 mm - 2 hernia size < 10 mm - 36 hernia size of 10 mm - 29 hernia size of 15 mm - 2 hernia size < 20 mm - 12 hernia size of 20 mm Page 6/ 13

In 2 cases, it was a recurrence. Hernias localization 3.2.2. Surgery For the 57 patients, the prostheses were introduced by a trocar under endoscopy via a total extraperitoneal technique (TEP).

7 In 2 cases, it was a recurrence. Hernias localization Surgery For the 57 patients, the prostheses were introduced by a trocar under endoscopy via a total extraperitoneal technique (TEP). A general anesthesia was practiced for all patients. The intervention duration was between 15 to 55 minutes (mean of 33 minutes). Intervention duration (in minutes) The patients who had unilateral hernia were treated by the installation of a single prosthesis and patients who had bilateral hernia were treated by the installation of two prostheses. References CO3A D+ and/or G+ of two different sizes were used in 69 cases: 24 implants of size 11x15 cm and 45 implants of size 12x16 cm. The reference CO3+ S of size 10x15cm was used in 12 cases. Page 7/ 13

Time of follow-up visit (in days) 4. RESULTS 4.1.

8 None of the 88 prostheses was fixed. The hospitalization length for 50/52 patients is between 1 to 4 days (mean of 1.7 days). Hospitalization duration (in days) Postoperative visit All patients were reviewed during a postoperative visit at 34 days on average (from 22 to 69 days). Time of follow-up visit (in days) 4. RESULTS 4.1. Tolerance data Preoperative complication No per-operative complication was recorded in the laparotomy group. Three per-operative complications were recorded in the laparoscopy group: 3 peritoneal breaking with 2 requiring a closure with either absorbable thread or vicryl 2/0. Page 8/ 13

9 Postoperative complication Laparotomy group (Lichtenstein technique) Six complications were recorded at the postoperative visit: - 1 discrete upstream edema related to the mesh incorporation (2.6%, 1/39) - 1 hematoma (2.6%, 1/39). - 4 pain (10.2%, 4/39). Two patients presented pain until the 3 rd postoperative week and one patient presented pain of constraint type until the 2 nd postoperative week. Three patients felt a constraint. One patient described a pain of constraint type and another patient described a constraint certainly related with the inflammatory process. In addition, one patient presented a discrete cicatricial pain at the end of the evening, another patient some normal twinges following efforts of load wearing and a last one brought back some small tugging. Twenty-nine (29/32) patients went back to a current activity at the postoperative visit. Laparoscopy group (TEP) Twenty-one (21) complications were recorded on 19 patients at the postoperative visit. It is: - 1 acute urinary retention (1.8%, 1/57) - 6 testicular syndromes (10.5%, 6/57) - 14 seromas (24.6%, 14/57) The acute urinary retention appeared in one patient who left the clinic the night of the surgery. He came back during the night with a full bladder, has a catheter and left the clinic when miction came back normally. Among the 6 testicular syndromes, one was accompanied by painful sensation, very well eased by paracetamol. The patient reported pain evaluated at 6 on the visual analogue scale (VAS). The 5 other testicular syndromes were of moderate to weak intensity. There were accompanied for 3 patients by a weak pain evaluated at 1 or 2 on the visual analogue scale (VAS). Among the 14 seroma, only 4 were accompanied by a moderate to weak pain evaluated from 1 to 3 on the visual analogue scale (VAS). Seroma observed in this group of patients were in majority painless and for the totality regressive. Three (3) seroma were of diameter < 1 cm and one was having a size of 20x30 mm. Two (2) patients presented a testicular syndrome accompanied by seroma. One of the patients had a voluminous scrotal inguinal hernia and presented banal post-surgery sequela: testicular syndrome of moderate intensity during 21 days, seroma whose regression was almost complete at 31 days post-surgery. The second patient, previously operated for a prostatic cancer by radical prostatectomy under laparoscopy and followed by a postoperative radiotherapy, presented a left external oblique inguinal hernia. This patient presented a minor testicular syndrome accompanied by a seroma of diameter < 1 cm, in process of resorption at 26 days post-surgery. Page 9/ 13

Most patients described small postoperative constraints during generally 4 to 5 days. These constraints were related to the surgery and the inflammatory reaction induced by the implant.

10 Most patients described small postoperative constraints during generally 4 to 5 days. These constraints were related to the surgery and the inflammatory reaction induced by the implant. No patient has constraint or discomfort related to the prosthesis. Only one patient on 56 does not retrieve a current activity at the postoperative visit. The time of return for 51/57 is between 2 to 21 days (mean of 9 days). Time of return to current activity (in days) 4.2. Efficacy data No reoperation and no recurrences were recorded on the 2 groups studied Device quality data The quality of the device was assessed, based on several criteria in the laparoscopy group: Handling/comfort of use of the prosthesis: it was deemed very satisfactory in 92.9% (52/56) and satisfactory in 7.1% (4/56) of cases. Flexibility: it was deemed very satisfactory in 92.9% (52/56) and satisfactory in 7.1% (4/56) of cases. Facility of introduction into a trocar: it was deemed middle in 74.5% (41/55) and satisfactory in 25.5% (14/55) of cases. Facility of installation and of positioning: it was deemed very satisfactory in 94.6% (53/56) and satisfactory in 5.4% (3/56) of cases. Shape memory of implant after his installation: it was deemed very satisfactory in 94.6% (53/56) and satisfactory in 5.4% (3/56) of cases. Adhesion to tissue: it was deemed middle in 92.9% (52/56) and satisfactory in 7.1% (4/56) of cases. Facility of repositioning: it was deemed very satisfactory in 94.6% (53/56) and satisfactory in 5.4% (3/56) of cases. Shape of the implant: it was deemed middle in 91.1% (51/56) and satisfactory in 8.9% (4/56) of cases. Comfort of the patient: it was deemed middle in 92.9% (52/56) and satisfactory in 7.1% (4/56) of cases. Page 10/ 13

11 Labeling: it was deemed clear in all cases (56/56). Packaging: it was deemed appropriate and secure in all cases (56/56). Operating instructions: it was deemed comprehensible in all cases (56/56). 5. Conclusion Twenty-seven (27) complications were reported in this clinical evaluation. No complication implicates the safety of the patients or the benefit-risk ratio. All these complications are awaited complication in the treatment of inguinal and femoral hernia and the sequela are simple. In particular, several current studies show a high rate of chronic pain with the Lichtenstein technique (1, 2), 5% to 45% according to the studies. This rate higher than in laparoscopy can be explained by the nervous terminations catches in the suture and by the chronic irritation of the ilioinguinal and iliohypogastric nerves in contact with the prosthesis (1). Seroma are early complications frequently observed following inguinal hernia surgery performed by totally extraperitoneal laparoscopy (4, 5, 6). A study on 105 patients shows by sonography, fluid collections compatible with seroma or hematoma in 33% of the patients (4). Indeed, seroma corresponds to a tissular secretion filling of the cavity occupied by the hernia. This inguinal collection could appear immediately after the surgery. In the majority of cases, a spontaneous resorption is achieved following few weeks. In our group of patients, the 14 seroma observed were regressive and in majority painless. No recurrence neither reoperation were recorded in this post-marketing follow-up in a short- term period on the Swing-Contact meshes. This result, very promising, will have to be confirmed by a long-term follow-up. Finally, it is important to note that no infection or intolerance was recorded. The results obtained in the group of patients operated by the Lichtenstein technique confirm safety and part of performances of the Swing-Contact implants. Indeed, these results do not allow concluding on the effectiveness of grips as all prostheses were fixed according to the recommendation of the Lichtenstein technique. In addition, the Lichtenstein technique being associated to a high rate of chronic pain, it is difficult to interpret the rate of pain evaluated at 10.2%. Nevertheless, no constraint or discomfort directly related to the prosthesis was recorded. Moreover the pain recorded is of short duration for 3 patients and not considered as a chronic pain (3). The complete safety and performance assessment of the Swing-Contact meshes has been possible with the data analysis obtained following the use of the implants in laparoscopy without fixation. Indeed, the effectiveness of the grips could be highlighted by the absence of recurrence and pain directly related to the prosthesis or the presence of grips. Page 11/ 13

12 BIBLIOGRAPHY (1) «Etat actuel du traitement de la hernie inguinale», Edouard Pélissier e-mémoires de l Académie Nationale de Chirurgie, 2009, 8 (2) : (2) «Comparison of endoscopic procedures vs lichtenstein and other open mesh techniques for inguinal hernia repair : A meta-analysis of randomized controlled trials», Schmedt CG, Sauerland S, Bittner R Surgical endoscopy, 2005, 19 (2): (3) International Association for the Study of Pain. Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the Study of pain, Subcommittee on Taxonomy Pain, 1986, Suppl 3: S1-226 (4) Early postoperative evaluation of groins after laparoscopic total extraperitoneal repair of inguinal hernias, Shpitz B, Kuriansky J, Werener M, Osadchi A, Tiomkin V, Bugayev N, Klein E. J Laparoendosc Adv Surg Tech A, 2004; 14 (6): (5) Totally extraperitoneal laparoscopic hernioplasty: the optimal surgical approach, Zhang H, Lin J, Liao Q, Xie N, Gui X, Li J, Hong S, Qin X, Lu Y Surg Laparosc Endosc Percutan Tech, 2009; 19 (6): (6) Total extraperitoneal (TEP) mesh repair of inguinal hernia in the developing world: comparison of low-cost indigenous ballon dissection versus direct telescopic dissection: a prospective randomized controlled study. Misra MC, Kumar S, Bansal VK Surg Endosc, 2008, 22 (9): Page 12/ 13

13 APPENDIX 1 LIST OF CENTERS Surgeon Address Speciality Dr LONJON Dr MAGNE Dr BERTOLASO Clinique Gale de Marignane Avenue Général R. Salan MARIGNANE Clinique Tivoli 91,rue de Rivière BORDEAUX Clinique du Pont de Chaume 330, avenue Marcel Unal MONTAUBAN General and visceral surgery Parietal digestive surgery Visceral surgery Page 13/ 13

JMSCR Vol 04 Issue 09 Page September 2016

JMSCR Vol 04 Issue 09 Page September 2016 JMSCR Vol 4 Issue 9 Page 4-47 September 6 www.jmscr.igmpublication.org Impact Factor 5.44 Index Copernicus Value: 8.7 ISSN (e)-47-76x ISSN (p) 455-45 DOI: http://dx.doi.org/.855/jmscr/v4i9.7 Comparative