Patient-reported chronic pain after open inguinal hernia repair with lightweight or heavyweight mesh: a prospective, patient-reported outcomes study.

BACKGROUND: Chronic pain after groin hernia repair is a significant problem, and it is unclear whether or not lightweight meshes help. This national register-based study investigated whether patients who underwent open anterior mesh inguinal hernia repair with lightweight mesh had less chronic pain than those who had hernia repair with heavyweight mesh. METHODS: All patients registered in the Swedish Hernia Register between September 2012 and October 2016 were asked to complete a questionnaire assessing patient-reported outcome measures 1 year after surgery. The present study examined open anterior repair with mesh sutured in place with non-absorbable sutures in male patients only. The primary endpoint, chronic pain, was defined as pain present in the past week that could not be ignored and interfered with concentration (on chores) and daily activities. RESULTS: In total, 23 259 male patients provided data for analysis (response rate 70·6 per cent). Rates of chronic pain after repairs using regular polypropylene lightweight mesh, composite (poliglecaprone-25) polypropylene lightweight mesh and polypropylene heavyweight mesh were 15·8, 15·6 and 16·2 per cent respectively. Adjusted multiple logistic regression analysis showed no significant differences between regular (odds ratio (OR) 0·98, 95 per cent c.i. 0·90 to 1·06) or composite (OR 0·95, 0·86 to 1·04) lightweight mesh versus heavyweight mesh. The most striking risk factor for chronic pain was young age; 19·4 per cent of patients aged less than 50 years experienced pain 1 year after hernia repair (OR 1·43, 1·29 to 1·60). CONCLUSION: Patient-reported chronic pain 1 year after open mesh repair of inguinal hernia was common, particularly in young men. The risk of developing chronic pain was not influenced by the type of mesh.

ANTECEDENTES: El dolor crónico tras la reparación de la hernia inguinal es un problema significativo y no se conoce con claridad si la utilización de mallas ligeras lo disminuye o no. Este estudio basado en un registro nacional, analizó si los pacientes sometidos a reparación de una hernia inguinal con malla anterior por vía abierta (open anterior mesh, OAM) tenían menos dolor crónico con mallas ligeras que pesadas. MÉTODOS: A todos los pacientes incluidos en el Registro de Hernia sueco entre septiembre de 2012 y octubre de 2016 se les pidió que respondieran un cuestionario que evaluaba los resultados percibidos por el paciente un año después de la cirugía. Se incluyeron solamente los pacientes del sexo masculino en los que la OAM se fijó con suturas reabsorbibles. La variable principal (dolor crónico) se definió como la presencia de dolor que no podía obviarse y que interfería la concentración (en las tareas) y las actividades diarias durante la semana anterior a la de la encuesta. RESULTADOS: Respondieron a la encuesta 23.259 (tasa de respuesta 70,6%) pacientes varones tras OAM. El análisis de regresión logística múltiple con razón de oportunidades (odds ratio, OR) ajustada no demostró diferencias significativas en el dolor crónico entre las mallas ligeras de polipropileno (15,8% (OR 0,98, i.c. del 95% 0,90-1,06)) o las mallas ligeras de polipropileno compuesto (poliglecaprona-25) (15,6% (OR 0,95, i.c. del 9% 0,86-1,04)) o las mallas de polipropileno pesado (16,2%). Sorprendentemente, el factor de riesgo para el dolor crónico fue la edad temprana (< 50 años) 19,3% (OR 1,43, i.c. del 95% 1,29-1,60)). CONCLUSIÓN: El dolor crónico percibido por el paciente un año después de una reparación de una hernia inguinal abierta y con colocación de una malla fue alto, especialmente en varones jóvenes. El tipo de malla no tuvo influencia en el riesgo de aparición de dolor crónico.

Onlay mesh repair for treatment of small umbilical hernias ≤ 2 cm in adults: a single-centre investigation.

PURPOSE: Previous studies on the repair of small umbilical hernias have suggested a lower recurrence rate with mesh compared to suture repair. An important question is in what anatomical position the mesh should be placed. The purpose of this study was to investigate the outcome of using a standardized 4 × 4 cm onlay-mesh for umbilical hernias ≤ 2 cm. METHODS: A retrospective study was conducted at a single centre in Sweden on all umbilical hernia repairs during 2015-2019. The follow-up time was at least four months. Patients were identified using the hospital medical database. Repairs performed with suture or a sublay, ventral patch and laparoscopic mesh positioning were excluded. The patient's demographics, comorbidities, intra-and post-operative details were considered. The primary outcome was surgical site complications within 30 days. The secondary outcome was a recurrence. RESULTS: 80 patients were repaired with a small onlay-mesh for an umbilical hernia ≤ 2 cm. The median (range) follow-up time was 29.0 (4.3-50.1) months. The median age was 46 (26-76) years old. The median body mass index was 28 (19-38) kg/m2. The male to female ratio was 2:1. 4 patients were identified with a surgical site post-operative complication; three with seromas and one with a superficial wound infection. 3 of these were given antibiotics. 2 patients were treated with wound openings bedside. There were no registered cases of recurrence. CONCLUSIONS: Repairing small umbilical hernias with a small onlay-mesh was safe with a low surgical site complication rate. Randomized trials are needed to assess whether mesh can reduce recurrences in umbilical hernia repairs ≤ 2 cm.

SUMMER Trial: mesh versus suture repair in small umbilical hernias in adults-a study protocol for a prospective randomized double-blind multicenter clinical trial.

BACKGROUND: Small umbilical hernia repair is one of the most common surgical performances in general surgery. Yet, a gold standard procedure for the repair is still lacking today. There is an increasing evidence that mesh could be advantageous compared to suture repair in lowering recurrence rates. An additional important question remains with regard to the optimal anatomical positioning of the mesh. We hypothesize that the use of an onlay mesh in small umbilical hernia defects can reduce recurrence rates without increasing the complications compared to a simple suture repair. METHODS: A prospective, national, multicenter, randomized, double-blind clinical trial comparing a standardized 4 × 4 cm onlay mesh to a conventional suture repair will be conducted. A total of 288 patients with a primary elective umbilical hernia ≤ 2 cm from 7 participating Swedish surgical centers will be enrolled. Intraoperative randomization will take place using a centralized web-based system resulting in total allocation concealment. Stratification will be done by surgical site and by defect size. Trial participants and follow-up clinical surgeons will be blinded to the assigned allocation. The primary outcome assessed will be postoperative recurrence at 1 and 3 years. Secondary outcomes assessed will be postoperative complications at 30 days and pain 1 year after surgery. DISCUSSION: Currently, there has been no randomized clinical trial comparing the recurrence rates between an onlay mesh repair and a simple suture repair for small umbilical hernia defects. How to best repair a small umbilical hernia continues to be debated. This trial design should allow for a good assessment of the differences in recurrence rate due to the large sample size and the adequate follow-up. Surgeons' concerns surrounding optimal anatomical positioning and fear for larger required dissections are understandable. A small onlay mesh may become an easy and safe method of choice to reduce recurrence rates. Guidelines for small umbilical hernia repairs have stressed the need for reliable data to improve treatment recommendations. We can expect that this trial will have a direct implication on small umbilical hernia repair standards. TRIAL REGISTRATION: ClinicalTrials.gov NCT04231071. Registered on 31 January 2020. SUMMER Trial underwent external peer review as part of the funding process.

Relaxing music as pre-medication before surgery: a randomised controlled trial.

INTRODUCTION: Patients who await surgery often suffer from fear and anxiety, which can be prevented by anxiolytic drugs. Relaxing music may be an alternative treatment with fewer adverse effects. This randomised clinical trial compared pre-operative midazolam with relaxing music. METHOD: Three hundred and seventy-two patients scheduled for elective surgery were randomised to receive pre-operative prevention of anxiety by 0.05-0.1 mg/kg of midazolam orally or by relaxing music. The main outcome measure was the State Trait Anxiety Inventory (STAI X-1), which was completed by the patients just before and after the intervention. RESULTS: Of the 177 patients who completed the music protocol, the mean and (standard deviation) STAI-state anxiety scores were 34 (8) before and 30 (7) after the intervention. The corresponding scores for the 150 patients in the midazolam group were 36 (8) before and 34 (7) after the intervention. The decline in the STAI-state anxiety score was significantly greater in the music group compared with the midazolam group (P<0.001, 95% confidence interval range -3.8 to -1.8). CONCLUSION: Relaxing music decreases the level of anxiety in a pre-operative setting to a greater extent than orally administrated midazolam. Higher effectiveness and absence of apparent adverse effects makes pre-operative relaxing music a useful alternative to midazolam for pre-medication.

Randomized clinical trial of groin hernia repair with titanium-coated lightweight mesh compared with standard polypropylene mesh.

BACKGROUND: Groin hernia repair is one of the commonest operations in general surgery. Existing techniques have very low and acceptable recurrence rates, but chronic pain and discomfort remain a problem for many patients. New mesh materials are being developed to increase biocompatibility, and the aim of this study was to compare a new titanium-coated lightweight mesh with a standard polypropylene mesh. METHODS: A randomized controlled single-centre clinical trial was designed, with the basic principle of one unit, one surgeon, one technique (Lichtenstein under general anaesthesia) and two meshes. Pain before and after surgery, and during convalescence (primary outcomes) was estimated in 317 patients. At 1-year clinical follow-up, recurrence, pain, discomfort and quality of life (secondary outcomes) were evaluated. RESULTS: Patients with the lightweight mesh returned to work after 4 days, compared with 6.5 days for the standard mesh (P = 0.040). The lightweight group returned to normal activity after 7 days, versus 10 days for the standard group (P = 0.005). There was no difference in postoperative pain or recurrence at the 1-year follow-up. CONCLUSION: Patients with the lightweight mesh had a shorter convalescence than those with the standard heavyweight mesh. REGISTRATION NUMBER: ISRCTN36979348 (http://www.controlled-trials.com).

Lower recurrence rate with heavyweight mesh compared to lightweight mesh in laparoscopic totally extra-peritoneal (TEP) repair of groin hernia: a nationwide population-based register study.

PURPOSE: Lightweight meshes (LWM) have shown benefits compared to heavyweight meshes (HWM) in terms of less postoperative pain and stiffness in open inguinal hernia repair. It appears to have similar advantages also in TEP, but concerns exist if it may be associated with higher recurrence rates. The aim of the study was to compare reoperation rate for recurrence of LWM to HWM in laparoscopic totally extra-peritoneal (TEP) repair. METHODS: All groin hernias operated on with TEP between 1 January 2005 and 31 December 2013 at surgical units participating in The Swedish Hernia Register were eligible. Data included clinically important hernia variables. Primary endpoint was reoperation for recurrence. Median follow-up time was 6.1 years (0-11.5) with minimum 2.5 years postoperatively. RESULTS: In total, 13,839 repairs were included for statistical analysis and 491 were re-operated for recurrence. Multivariate analysis demonstrated significantly increased risk of reoperation for recurrence in LWM 4.0% (HR 1.56, P < 0.001) compared to HWM 3.2%. This was most evident in direct hernias (HR 1.75, P < 0.001) and in hernia repairs with a defect > 3 cm (HR 1.54, P < 0.021). The risk of recurrence with use of LWM in indirect hernias and in hernia repairs with a defect < 1.5 cm was more comparable to HWM. CONCLUSIONS: Lightweight meshes were associated with an increased risk of reoperation for recurrence compared to HWM. While direct hernias and larger hernia defects may benefit from HWM to avoid increased recurrence rates, LWM is recommended to be used in indirect and smaller hernia defects in TEP repair.

Early results of a randomised trial comparing Prolene and VyproII-mesh in endoscopic extraperitoneal inguinal hernia repair (TEP) of recurrent unilateral hernias.

The purpose of this study was to compare a lightweight mesh to a standard polypropylene hernia mesh in endoscopic extraperitoneal hernioplasty in recurrent hernias. A total of 140 men with recurrent unilateral inguinal hernias were randomised to a totally extraperitoneal endoscopic hernioplasty (TEP) with Prolene or VyproII in a single-blinded multi-center trial. The randomisation and all data handling were performed through the Internet. 137 patients were operated as allocated. Follow-up was completed in 88% of the patients. The median operation times were 55 (24-125) min and 53.5 (21-123) min for the Prolene and VyproII groups, respectively. The meshes had comparable results in the surgeon's assessment of the handling of the mesh, return to work, return to daily activities, complications, postoperative pain and quality of life during the first 8 weeks of rehabilitation, except in General Health (GH) SF-36, where the VyproII-group had a significantly better score (P=0.045). The use of Prolene and VyproII-meshes in endoscopic repair of recurrent inguinal hernia seems to result in similar short-term outcomes and quality of life.

Location of recurrent groin hernias at TEP after Lichtenstein repair: a study based on the Swedish Hernia Register.

PURPOSE: To investigate which type of hernia that has the highest risk of a recurrence after a primary Lichtenstein repair. METHODS: Male patients operated on with a Lichtenstein repair for a primary direct or indirect inguinal hernia and with a TEP for a later recurrence, with both operations recorded in the Swedish Hernia Register (SHR), were included in the study. The study period was 1994-2014. RESULTS: Under the study period, 130,037 male patients with a primary indirect or direct inguinal hernia were operated on with a Lichtenstein repair. A second operation in the SHR was registered in 2236 of these patients (reoperation rate 1.7 %). TEP was the chosen operation in 737 in this latter cohort. The most likely location for a recurrence was the same as the primary location. If the recurrences change location from the primary place, we recognized that direct hernias had a RR of 1.51 to having a recurrent indirect hernia compared to having a direct recurrence after an indirect primary hernia repair. CONCLUSIONS: Recurrent hernias after Lichtenstein are more common on the same location as the primary one, compared to changing the location.

Early results of a randomized multicenter trial comparing Prolene and VyproII mesh in bilateral endoscopic extraperitoneal hernioplasty (TEP).

BACKGROUND: The use of mesh in inguinal hernia surgery has become increasingly popular despite the potentially harmful effects that foreign material may exert on human tissue. The purpose of this study was to compare the use of a lightweight mesh vs a standard hernia mesh in bilateral endoscopic hernioplasty. METHODS: This single-blinded multicenter trial, 140 men with bilateral inguinal hernias were randomized to undergo totally extraperitoneal endoscopic hernioplasty (TEP) with either Prolene or VyproII. The randomization and all data management were done via the Internet. RESULTS: A total of 139 patients were operated on as allocated. The follow-up was complete in 94% of the patients. The median (range) operating times were 85 min (45-140) and 73 min (35-165) for the Prolene and VyproII groups, respectively. (p = 0.01). The difference was due to uneven distribution of the allocated patients to study groups among individual surgeons. The time to return to work was similar (11 vs 9 days, p = 0.08). The time to return to normal daily activities was 19 days (1-133) in the Prolene group and 12.5 days (0-237) in the VyproII group (p = 0.06). There were no significant differences between the groups in their scores on the Visual Analogue Scale or SF-36 Health Scores during the 8-week follow-up. CONCLUSIONS: The use of Prolene and VyproII meshes in bilateral endoscopic repair of inguinal hernia seems to result in similar short-term outcome and quality of life. However, there was a tendency toward faster return to normal activity among VyproII patients.

Intestinal obstruction after inguinal and femoral hernia repair: a study of 33,275 operations during 1992-2000 in Sweden.

The risk of intra-abdominal intestinal obstruction after open or laparoscopic hernioplasty is, to our knowledge, not known. The transabdominal laparoscopic (TAPP) route brings a potential risk of abdominal adhesions, which may increase the risk of postoperative intestinal obstruction. The pre-peritoneal route laparoscopically, totally extraperitoneal laparoscopic hernioplasty (TEP), should not increase this risk since the abdominal cavity is not entered. The Swedish Hernia Register, with 33,275 patients operated on for single primary unilateral groin hernia during the period 1992-2000, was linked to the Swedish Inpatient register and the Swedish Death register for the period 1987-2000. The risk of postoperative intestinal obstruction was low, 1.02 per 1,000 personyears. The highest adjusted relative risks (RR) were found in patients with previous admissions for abdominal inflammations or operations. The risk increased with the number of admissions. After an acute operation, and in patients older than 60 years, there was also a significantly increased risk. The RR was 2.79 (95% CI 1.01-7.42) after TAPP and 0.57 (95% CI 0.07-4.33) following TEP compared to patients operated on by the Lichtenstein method. None of the patients undergoing open hernia operations had a significantly increased risk. TAPP increased the risk of postoperative intestinal obstruction, but other risk factors, especially previous abdominal surgery or inflammation, have greater influence.

One year results of a randomised controlled multi-centre study comparing Prolene and Vypro II-mesh in Lichtenstein hernioplasty.

A standard polypropylene mesh used in Lichtenstein's operation induces a strong foreign tissue reaction with potential harmful effects. A mesh with less polypropylene could possibly be beneficial. Six hundred men with primary unilateral inguinal hernias were randomised to Lichtenstein's operation using a Prolene- or Vypro II-mesh in six centres. The patients were blinded to which mesh they received. A validated questionnaire assessing recurrence and pain along with SF-36 Health Survey was sent after 1 year to all patients and a selected group was clinically examined. Of the 591 operated patients, 526 (89.0%) returned the questionnaire. 188 patients had some complaints or sensations of which 111 patients were clinically examined. The mean follow-up time was 13.6 (SD. 4.0) months. The incidence of hernia recurrence (four vs. four patients) and neuralgia (three vs. four patients) did not differ between Prolene and Vypro II-groups, respectively. One Vypro II-patient was re-operated due to neuralgia. There was no difference in the SF-36 scores. The results of Lichtenstein's operation with either Prolene or Vypro II do not seem to differ significantly.

Comparison of laparoscopic and open Nissen fundoplication 2 years after operation. A prospective randomized trial.

BACKGROUND: Laparoscopic operation has replaced the conventional open procedure in the treatment of gastroesophageal reflux disease (GERD) in spite of the fact that long-term results based on controlled clinical trials have been lacking. The objective of this study was to compare outcome, quality of life, and patient satisfaction after laparoscopic and open Nissen fundoplication in a community hospital setting with a 2-year follow-up. METHODS: Forty-two patients with GERD were randomized to either laparoscopic (LNF) or open (ONF) Nissen fundoplication. Outcome evaluation included reflux symptoms, gastrointestinal quality of life (GIQLI), and upper GI endoscopy. RESULTS: Esophagitis was cured among all patients in the LNF group and in 90% of the ONF group. There were two patients (10%) in both groups who had medicine-dependent recurrent reflux together with significant worsening in the GIQLI scores. One patient in the LNF group has been reoperated due to a suture granuloma in the left epigastric port. Two patients in the LNF group needed esophageal dilatation due to persistent dysphagia. GIQLI scores (scale, 0-144) were equally normalized in both groups. Overall, 90% in the LNF and 100% in the ONF group were either satisfied or very satisfied with the operation. There was only one patient (LNF) who would not choose to have the operation again. CONCLUSIONS: Laparoscopic and open Nissen fundoplication seem to be equally effective methods for improving reflux symptoms and quality of life, resulting in a high rate of satisfaction among patients with an intermediate follow-up period of 2 years.

Five-year outcome of laparoscopic and Lichtenstein hernioplasties.

BACKGROUND: Laparoscopic hernia repair has been proved superior to open repairs in terms of short-term results, but long-term results of laparoscopic and open mesh repairs have been lacking until recently. METHODS: A total of 123 patients were randomly allocated to two treatment groups comparing laparoscopic and Lichtenstein hernioplasties in three separate trials. The first and second trials compared small and large mesh used in transabdominal preperitoneal repairs, and the third study compared totally extraperitoneal hernioplasty with the Lichtenstein operation. A 5-year follow-up visit was scheduled to assess recurrencies, symptoms, and patient satisfaction. RESULTS: For the follow up evaluation, 121 (98.4%) of the patients were reached. There were five hernia recurrences in the laparoscopic group (small mesh) and two in the Lichtenstein group (difference, 5%; 95% confidence interval, -4-13%; p = 0.3). One patient who underwent the transabdominal preperitoneal polypropylene procedure underwent reoperation 3 years later because of dense small bowel adhesions at the inguinal surgical site. Chronic groin pain was more common after open operation (0 vs 4) patients (difference 7%; confidence interval, -0.4-16%; p = 0.04). Ten patients (16%) in the laparoscopic group and 12 (20%) in the open group reported discomfort or pain at the surgical site. CONCLUSIONS: Both laparoscopic and Lichtenstein hernioplasties have a low risk for hernia recurrence if proper mesh size is used. The patients who undergo hernioplasty with open mesh hernioplasty seem to experience chronic symptoms and pain more often than those managed with the laparoscopic procedure.

Is a dissection balloon beneficial in totally extraperitoneal endoscopic hernioplasty (TEP)? A randomized prospective multicenter study.

BACKGROUND: Laparoscopic hernioplasty has been criticized because of its technical complexity and increased costs. Disposable dissection balloons can be used to facilitate the creation of the initial working space in totally extraperitoneal endoscopic hernioplasty (TEP), but their use adds to the cost of the operation. METHODS: A total of 322 men with unilateral, primary, or recurrent inguinal hernias were randomized to undergo TEP with or without a dissection balloon. RESULTS: In the group with the balloon, three of 161 patients (2.5%) required conversion to transabdominal preperitoneal hernioplasty (TAPP), or open herniorraphy, whereas 17 of 161 patients (10.6%) were converted to TAPP or open herniorraphy in the group without the balloon (p = 0.002). The mean operation time was 55 min in the group with the balloon and 63 min in the group without the balloon (p = 0.004). There was no difference between them in postoperative morbidity, and there were no major complications in either group. The recurrence rate was 3.1% in the group with the balloon and 3.7 % in the group without the balloon (p = 0.8). CONCLUSION: The use of a dissection balloon in TEP reduces the conversion rate and may be especially beneficial early in the learning curve.

Is a dissection balloon beneficial in bilateral, totally extraperitoneal, endoscopic hernioplasty? A randomized, prospective, multicenter study.

SUMMARY: Laparoscopic hernioplasty has been criticized because of its technical complexity and increased costs. Disposable dissection balloons can be used to gain the initial working space in totally extraperitoneal endoscopic (TEP) hernioplasty, but this increases its cost. Forty-four men with bilateral, primary or recurrent inguinal hernias were randomized to undergo TEP with or without dissection balloon. There were two conversions to transabdominal preperitoneal hernioplasty, or open herniorrhaphy, in the group with balloon and four in the group without balloon. There was no difference in the postoperative morbidity or operation time between the two groups, and there were no major complications in either group. The recurrence rate was 4.3% in the group with the balloon and 7.1% in the group without the balloon. There were no statistically significant differences between the groups. Although our study population is too small to detect small differences between the groups, it seems that the use of a dissection balloon is not beneficial in a bilateral TEP.

[Simulator training in medicine and health care. A new pedagogic model for good patient safety]. / Simulatorträning inom medicinsk verksamhet. Ny pedagogisk modell för god patientsäkerhet.

Advanced simulation within medicine and health care is a rapidly growing field. Simulator based training can be applied in minimal invasive surgery, in endoscopic procedures as well as in anaesthesia and critical care management. At Huddinge University Hospital a center for advanced simulation of both endoscopic surgery and anaesthesia/critical care management is currently being set up. The objective is to focus on improved medical and health care training and thus improving patient safety by reducing medical errors.

Outpatient laparoscopic cholecystectomy. A prospective study with 100 consecutive patients.

One hundred patients with cholelithiasis were included in a prospective consecutive follow-up study to evaluate laparoscopic cholecystectomy in a day surgical setting. The median operating time was 70 min. In 96% of the patients, it was possible to perform peroperative cholangiography. The median time off work was 7 days and the median time to full recovery was 14 days. Five patients were admitted due to weakness/nausea. Six patients were admitted due to conversion to open surgery or choledocholithiasis. Eighty-nine patients were treated in ambulatory surgery. We conclude that laparoscopic outpatient cholecystectomy can be performed safely with a low unplanned admission rate.

Hernia repair: the search for ideal meshes.

BACKGROUND: Effective repair of hernia is a difficult task. There have been many advances in hernia repair techniques over the past 50 years, but new strategies must be considered to enhance the success of herniorrhaphy. DISCUSSION: At the 30th International Congress of the European Hernia Society, nine experts in hernia repair and experimental mesh evaluation participated in a roundtable discussion about today's unmet needs in hernia repair, including what constitutes an "ideal" hernia repair and the portfolio of "ideal" mesh prostheses. Defining characteristics of lightweight mesh, mesh alternatives, the surgeon's role in hernia repair, adverse events, the unmet requirements for today's hernia repair, and optimized animal models were among the topics discussed. CONCLUSION: The ideal mesh's construction is still in progress, but greater understanding of its critical characteristics was explored. It is hoped that these suggestions will lead to the development of improved hernia treatments and a maximally effective portfolio of hernia mesh prostheses.