Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial.

BACKGROUND: The objective of the study was to analyse patient-reported outcome measures (PROMs), seroma formation, long-term recurrence and chronic pain after closure of the fascial defect in patients undergoing laparoscopic umbilical hernia mesh repair. METHODS: This was a randomized double-blinded trial in patients undergoing elective laparoscopic umbilical hernia repair comparing sutured closure of the fascial defect before intraperitoneal onlay mesh (IPOM) repair with a no-closure IPOM repair. Postoperative pain, movement limitations, discomfort and fatigue were registered before surgery and on postoperative days 1-3, 7 and 30. Seroma formation, quality of life and cosmesis were assessed at day 30, and at 2 years of follow-up. Recurrence (clinical and reoperation) and chronic pain were assessed after 2 years. RESULTS: Eighty patients were randomized. Median defect sizes in closure and no-closure groups were 2·5 (range 1·5-4·0) and 2·5 (2·0-5·5) cm respectively (P = 0·895). There were no significant differences in early and late postoperative pain or in any other early or late PROMs, except for early fatigue which was higher in the closure group (P = 0·011). Seroma formation after 30 days was significantly reduced after closure (14 of 40; 35 (95 per cent c.i. 22 to 51) per cent) compared with no closure (22 of 38; 58 (42 to 72) per cent) (P = 0·043). Cumulative recurrence after 2 years was lower in the closure group: 5 of 36 (7 (3 to 17) per cent) versus 12 of 37 (19 (10 to 33) per cent) for no closure (P = 0·047). CONCLUSION: Closure of the fascial defect in laparoscopic umbilical hernia IPOM repair significantly reduced early seroma formation and long-term recurrence without inducing side-effects such as pain, or other early or late PROMs. Registration number: NCT01962480 ( https://www.clinicaltrials.gov).

Fluorescence or X-ray cholangiography in elective laparoscopic cholecystectomy: a randomized clinical trial.

BACKGROUND: Safe laparoscopic cholecystectomy may necessitate biliary imaging, and non-invasive fluorescence cholangiography may have advantages over contrast X-ray cholangiography. This trial compared fluorescence and X-ray cholangiography for visualization of the critical junction between the cystic, common hepatic and common bile ducts. METHODS: This non-inferiority blinded RCT included patients who had either intraoperative fluorescence cholangiography using 0·05 mg/kg indocyanine green or X-ray cholangiography during elective laparoscopic cholecystectomy. RESULTS: Between March 2015 and August 2018, a total of 120 patients were randomized (60 in each group). There were no drop-outs and 30-day follow-up data were available for all patients. In intention-to-treat analysis, there was no difference between the fluorescence and X-ray cholangiography groups in ability to visualize the critical junction (49 of 60 versus 51 of 60 respectively; P = 0·230). Fluorescence cholangiography was faster by a few minutes: median 2·0 (range 0·5-5·0) versus 4·8 (1·3-17·6) min (P < 0·001). CONCLUSION: Fluorescence cholangiography was confirmed to be non-inferior to X-ray cholangiography in visualizing the critical junction during laparoscopic cholecystectomy. Registration number: NCT02344654 ( http://www.clinicaltrials.gov).

ANTECEDENTES: La práctica de una colecistectomía laparoscópica segura puede requerir imágenes de la vía biliar, en las cuales la colangiografía con fluorescencia no invasiva puede tener ventajas sobre la colangiografía con contraste con rayos X. Este ensayo comparó la colangiografía con fluorescencia con la colangiografía con rayos X para la visualización de la unión crítica entre el conducto cístico, el conducto hepático común y los conductos biliares comunes. MÉTODOS: Ensayo clínico aleatorizado, ciego, de no inferioridad que incluyó a 120 pacientes en los que durante la colecistectomía laparoscópica electiva se practicó una colangiografía con fluorescencia intraoperatoria utilizando 0,05 mg/kg de verde de indocianina o una colangiografía con rayos X. RESULTADOS: De marzo de 2015 a agosto de 2018, se aleatorizaron un total de 120 pacientes (6 en cada grupo), en los que no hubo abandonos y con datos de seguimiento de 30 días disponibles en todos ellos. Basado en un análisis por intención de tratamiento, la capacidad de visualizar la unión crítica fue igual entre los dos grupos (49/60 versus 51/60, P = 0,23). La colangiografía con fluorescencia fue más rápida de realizar, en unos pocos minutos (mediana 2 min (rango 0,5-5,0) versus 5 min (rango 5,2-17,6), P < 0,001). CONCLUSIÓN: Se confirmó que la colangiografía con fluorescencia no fue inferior a la colangiografía con rayos X para visualizar la unión crítica durante la colecistectomía laparoscópica.

Differential recurrence after laparoscopic incisional hernia repair: importance of a nationwide registry-based mesh surveillance.

BACKGROUND: Identification of suboptimal mesh products is essential to improve the outcome after hernia surgery. This study investigated whether a national clinical database combined with administrative registries may serve as a tool for postmarketing evaluation of mesh products for hernia surgery. METHODS: This was a propensity score-matched case-control cohort study comparing outcomes in patients undergoing laparoscopic incisional hernia repair with either one particular mesh or any other synthetic mesh. Data on patients registered in the Danish Ventral Hernia Database between 2010 and 2016 were combined with administrative data from the Danish National Patient Registry. The primary outcome was operation for recurrence. Secondary outcomes were 30-day readmission, 30-day reoperation for complications (excluding hernia recurrence), and mortality after 30 and 90 days. RESULTS: In total, 740 patients who underwent repair with one particular mesh were matched with 1479 patients who received any other synthetic mesh. The rate of repair for hernia recurrence was significantly higher in the particular mesh group than in the reference group: 12·8 versus 6·3 per cent respectively (hazard ratio 2·09, 95 per cent c.i. 1·57 to 2·79; P < 0·001). Use of the particular mesh increased the risk of readmission (odds ratio (OR) 1·53, 1·16 to 2·01; P = 0·002) and reoperation for a complication (OR 1·60, 1·03 to 2·47, P = 0·030). No difference in mortality was found. CONCLUSION: Clinical registries with prospectively collected data can provide long-term surveillance of commercial mesh. Laparoscopic incisional hernia repair with one particular mesh was associated with an increased rate of short-term complications and double the risk of repair for recurrence.

ANTECEDENTES: Es esencial identificar los productos subóptimos referidos a las mallas para mejorar los resultados en la cirugía de la hernia. Este estudio analizó si un registro clínico nacional combinado con registros de bases de datos administrativos puede servir como herramienta para la evaluación post-comercialización de productos de mallas para cirugía de la hernia. MÉTODOS: Se efectuó un estudio de emparejamiento por puntaje de propensión de una cohorte de casos y controles en el que se comparaban los resultados de la malla Physiomesh® frente a cualquier otra malla sintética en pacientes sometidos a una reparación laparoscópica de una eventración. Se combinaron los datos de los pacientes del registro danés de hernia entre 2010 y 2016 con los datos administrativos del registro nacional de pacientes de Dinamarca. La variable principal fue la reintervención por recidiva. Las variables secundarias fueron el reingreso a 30 días, la reoperación a 30 días por complicaciones (excluyendo la recidiva de la hernia) y la mortalidad a 30 y 90 días. RESULTADOS: Para la reparación herniaria se utilizó la malla Physiomesh® en 740 pacientes, que se emparejaron mediante el análisis por puntaje de propensión con 1.479 pacientes en los que se colocó otra malla sintética. La reintervención por recidiva herniaria fue significativamente mayor en el grupo Physiomesh® (12,8%) que en el grupo de referencia (6,3%); cociente de riesgos instantáneos (hazard ratio, HR): 2,09 (i.c. del 95%: 1,57-2,79), P < 0,001. El riesgo de reingreso (razón de oportunidades, odds ratio, OR: 1,53, 1,16-2,01, P = 0,002)) y de reoperación por una complicación (OR: 1,60, 1,03-2,47, P = 0,030) fueron superiores en el grupo Physiomesh®. No hubo diferencia en la mortalidad. CONCLUSIÓN: Los grandes registros clínicos con datos recogidos de forma prospectiva pueden ser útiles para efectuar el seguimiento a largo plazo de una malla comercializada para garantizar la seguridad del producto y su calidad quirúrgica. La reparación laparoscópica de una eventración con la malla Physiomesh® se asociaba con un riesgo doble de recidiva y un aumento de la tasa de complicaciones a corto plazo.

Low anterior resection syndrome in a Scandinavian population of patients with rectal cancer: a longitudinal follow-up within the QoLiRECT study.

AIM: Low anterior resection syndrome (LARS) is common after low anterior resection. Our aim was to evaluate the prevalence and 'bother' (subjective, symptom-associated distress) of major LARS after 1 and 2 years, identify possible risk factors and relate the bowel function to a reference population. METHOD: The QoLiRECT (Quality of Life in RECTal cancer) study is a Scandinavian prospective multicentre study including 1248 patients with rectal cancer, of whom 552 had an anterior resection. Patient questionnaires were distributed at diagnosis and after 1, 2 and 5 years. Data from the baseline and at 1- and 2-year follow-up were included in this study. RESULTS: The LARS score was calculated for 309 patients at 1 year and 334 patients at 2 years. Prevalence was assessed by a generalized linear mixed effects model. Major LARS was found in 63% at 1 year and 56% at 2 years. Bother was evident in 55% at 1 year, decreasing to 46% at 2 years. Major LARS was most common among younger women (69%). Among younger patients, only marginal improvement was seen over time (63-59%), for older patients there was more improvement (62-52%). In the reference population, the highest prevalence of major LARS-like symptoms was noted in older women (12%). Preoperative radiotherapy, defunctioning stoma and tumour height were found to be associated with major LARS. CONCLUSION: Major LARS is common and possibly persistent over time. Younger patients, especially women, are more affected, and perhaps these patients should be prioritized for early stoma closure to improve the chance of a more normal bowel function.

Two-year results of the randomized clinical trial DILALA comparing laparoscopic lavage with resection as treatment for perforated diverticulitis.

BACKGROUND: Traditionally, perforated diverticulitis with purulent peritonitis was treated with resection and colostomy (Hartmann's procedure), with inherent complications and risk of a permanent stoma. The DILALA (DIverticulitis - LAparoscopic LAvage versus resection (Hartmann's procedure) for acute diverticulitis with peritonitis) and other randomized trials found laparoscopic lavage to be a feasible and safe alternative. The medium-term follow-up results of DILALA are reported here. METHODS: Patients were randomized during surgery after being diagnosed with Hinchey grade III perforated diverticulitis at diagnostic laparoscopy. The primary outcome was the proportion of patients with one or more secondary operations from 0 to 24 months after the index procedure in the laparoscopic lavage versus Hartmann's procedure groups. The trial was registered as ISRCTN82208287. RESULTS: Forty-three patients were randomized to laparoscopic lavage and 40 to Hartmann's procedure. Patients in the lavage group had a 45 per cent reduced risk of undergoing one or more operations within 24 months (relative risk 0·55, 95 per cent c.i. 0·36 to 0·84; P = 0·012) and had fewer operations (ratio 0·51, 95 per cent c.i. 0·31 to 0·87; P = 0·024) compared with those in the Hartmann's group. No difference was found in mean number of readmissions (1·37 versus 1·50; P = 0·221) or mortality between patients randomized to laparoscopic lavage or Hartmann's procedure. Three patients in the lavage group and nine in the Hartmann's group had a colostomy at 24 months. CONCLUSION: Laparoscopic lavage is a better option for perforated diverticulitis with purulent peritonitis than open resection and colostomy.

Multidisciplinary perioperative protocol in patients undergoing acute high-risk abdominal surgery.

BACKGROUND: Acute high-risk abdominal (AHA) surgery carries a very high risk of morbidity and mortality and represents a massive healthcare burden. The aim of the present study was to evaluate the effect of a standardized multidisciplinary perioperative protocol in patients undergoing AHA surgery. METHODS: The AHA study was a prospective single-centre controlled study in consecutive patients undergoing AHA surgery, defined as major abdominal pathology requiring emergency laparotomy or laparoscopy including reoperations after elective gastrointestinal surgery. Consecutive patients were included after initiation of the AHA protocol as standard care. The intervention cohort was compared with a predefined, consecutive historical cohort of patients from the same department. The protocol involved continuous staff education, consultant-led attention and care, early resuscitation and high-dose antibiotics, surgery within 6 h, perioperative stroke volume-guided haemodynamic optimization, intermediate level of care for the first 24 h after surgery, standardized analgesic treatment, early postoperative ambulation and early enteral nutrition. The primary outcome was 30-day mortality. RESULTS: Six hundred patients were included in the study and compared with 600 historical controls. The unadjusted 30-day mortality rate was 21·8 per cent in the control cohort compared with 15·5 per cent in the intervention cohort (P = 0·005). The 180-day mortality rates were 29·5 and 22·2 per cent respectively (P = 0·004). CONCLUSION: The introduction of a multidisciplinary perioperative protocol was associated with a significant reduction in postoperative mortality in patients undergoing AHA surgery. NCT01899885 (http://www.clinicaltrials.gov).

Recurrence rate after absorbable tack fixation of mesh in laparoscopic incisional hernia repair.

BACKGROUND: The mesh fixation technique in laparoscopic incisional hernia repair may influence the rates of hernia recurrence and chronic pain. This study investigated the long-term risk of recurrence and chronic pain in patients undergoing laparoscopic incisional hernia repair with either absorbable or non-absorbable tacks for mesh fixation. METHODS: This was a nationwide consecutive cohort study based on data collected prospectively concerning perioperative information and clinical follow-up. Patients undergoing primary, elective, laparoscopic incisional hernia repair with absorbable or non-absorbable tack fixation during a 4-year interval were included. Follow-up was by a structured questionnaire regarding recurrence and chronic pain, supplemented by clinical examination, and CT when indicated. Recurrence was defined as either reoperation for recurrence or clinical/radiological recurrence. RESULTS: Of 1037 eligible patients, 84·9 per cent responded to the questionnaire, and 816 were included for analysis. The median observation time for the cohort was 40 (range 0-72) months. The cumulative recurrence-free survival rate was 71·5 and 82·0 per cent after absorbable and non-absorbable tack fixation respectively (P = 0·007). In multivariable analysis, the use of absorbable tacks was an independent risk factor for recurrence (hazard ratio 1·53, 95 per cent c.i. 1·11 to 2·09; P = 0·008). The rate of moderate or severe chronic pain was 15·3 and 16·1 per cent after absorbable and non-absorbable tack fixation respectively (P = 0·765). CONCLUSION: Absorbable tack fixation of the mesh was associated with a higher risk of recurrence than non-absorbable tacks for laparoscopic mesh repair of incisional hernia, but did not influence chronic pain.

Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy.

BACKGROUND: There are no randomized studies that compare outcomes after single-incision (SLC) and conventional multi-incision (MLC) laparoscopic cholecystectomy under an optimized perioperative analgesic regimen. METHODS: This patient- and assessor-blinded randomized three-centre clinical trial compared SLC and MLC in women admitted electively with cholecystolithiasis. Outcomes were registered on the day of operation (day 0), on postoperative days 1, 2, 3 and 30, and 12 months after surgery. Blinding of the patients was maintained until day 3. The primary endpoint was pain on movement measured on a visual analogue scale, reported repeatedly by the patient until day 3. RESULTS: The intention-to-treat population comprised 59 patients in the SLC and 58 in the MLC group. There was no significant difference between the groups with regard to any of the pain-related outcomes, on-demand administration of opioids or general discomfort. Median duration of surgery was 32·5 min longer in the SLC group (P < 0·001). SLC was associated with a reduced incidence of vomiting on day 0 (7 versus 22 per cent; P = 0·019). The incidences of wound-related problems were comparable. One patient in the SLC group experienced a biliary leak requiring endoscopic retrograde cholangiopancreatography. The rates of incisional hernia at 12-month follow-up were 2 per cent in both groups. Cosmetic rating was significantly improved after SLC at 1 and 12 months (P < 0·001). CONCLUSION: SLC did not significantly diminish early pain in a setting with optimized perioperative analgesic patient care. SLC may reduce postoperative vomiting. REGISTRATION NUMBER: NCT01268748 (http://www.clinicaltrials.gov).

Determining the value of the abdominal core health quality collaborative to support regulatory decisions.

PURPOSE: The study objective is to document value created by real-world evidence from the Abdominal Core Health Quality Collaborative (ACHQC) for regulatory decisions. The ACHQC is a national effort that generates data on hernia repair techniques and devices. METHODS: Two retrospective cohort evaluations compared cost and time of ACHQC analyses to traditional postmarket studies. The first analysis was based on 25 reports submitted to the European Medicines Agency of 20 mesh products for post-market surveillance. A second analysis supported label expansion submitted to the Food and Drug Administration, Center for Devices and Radiological Health for a robotic-assisted surgery device to include ventral hernia repair. Estimated costs of counterfactual studies, defined as studies that might have been done if the registry had not been available, were derived from a model described in the literature. Return on investment, percentage of cost savings, and time savings were calculated. RESULTS: 45,010 patients contributed to the two analyses. The cost and time differences between individual 25 ACHQC analyses (41,112 patients) and traditional studies ranged from $1.3 to $2.2 million and from 3 to 4.8 years, both favoring use of the ACHQC. In the second label expansion analysis (3,898 patients), the estimated return on investment ranged from 11 to 461% with time savings of 5.1 years favoring use of the ACHQC. CONCLUSIONS: Compared to traditional postmarket studies, use of ACHQC data can result in cost and time savings when used for appropriate regulatory decisions in light of key assumptions.

Lower reoperation rate for recurrence after mesh versus sutured elective repair in small umbilical and epigastric hernias. A nationwide register study.

BACKGROUND: Repair for a small (≤ 2 cm) umbilical and epigastric hernia is a minor surgical procedure. The most common surgical repair techniques are a sutured repair or a repair with mesh reinforcement. However, the optimal repair technique with regard to risk of reoperation for recurrence is not well documented. The aim of the present study was in a nationwide setup to investigate the reoperation rate for recurrence after small open umbilical and epigastric hernia repairs using either sutured or mesh repair. MATERIALS AND METHODS: This was a prospective cohort study based on intraoperative registrations from the Danish Ventral Hernia Database (DVHD) of patients undergoing elective open mesh and sutured repair for small (≤ 2 cm) umbilical and epigastric hernias. Patients were included during a 4-year study period. A complete follow-up was obtained by combining intraoperative data from the DVHD with data from the Danish National Patient Register. The cumulative reoperation rates were obtained using cumulative incidence plot and compared with the log rank test. RESULTS AND CONCLUSIONS: In total, 4,786 small (≤ 2 cm) elective open umbilical and epigastric hernia repairs were included. Age was median 48 years (range 18-95 years). Follow-up was 21 months (range 0-47 months). The cumulated reoperation rates for recurrence were 2.2 % for mesh reinforcement and 5.6 % for sutured repair (P = 0.001). The overall cumulated reoperation rate for sutured and mesh repairs was 4.8 %. In conclusion, reoperation rate for recurrence for small umbilical and epigastric hernias was significantly lower after mesh repair compared with sutured repair. Mesh reinforcement should be routine in even small umbilical or epigastric hernias to lower the risk of reoperation for recurrence avoid recurrence.

Randomized clinical trial of dexamethasone versus placebo in laparoscopic inguinal hernia repair.

BACKGROUND: The effect of dexamethasone on recovery and length of convalescence has not been evaluated in patients after laparoscopic groin hernia repair. It was hypothesized that preoperative intravenous dexamethasone would reduce postoperative pain. METHODS: Men undergoing transabdominal preperitoneal (TAPP) inguinal hernia repair were randomized to receive either a single intravenous dose of 8 mg dexamethasone or placebo (saline) 30-60 min before operation in a randomized double-blind trial. Patients in the two groups received similar standardized anaesthesia and analgesic regimens. The primary outcome measure was pain during coughing on postoperative day 1. Secondary outcomes were postoperative discomfort, fatigue and length of convalescence. Pain scores, discomfort and fatigue were recorded before surgery and daily on postoperative days 0-3 in a standard manner using visual analogue, verbal rating and numerical rating scales. The use of analgesics and antiemetics on the day of operation was recorded. The duration of time away from work and leisure activities was registered. RESULTS: The study enrolled 80 patients. No significant differences were found between the groups regarding postoperative pain, need for analgesia, discomfort, fatigue, nausea, vomiting or length of convalescence. Patients who received placebo used significantly more antiemetics in the postanaesthesia care unit (PACU) than patients in the dexamethasone group (P = 0.026). CONCLUSION: A single preoperative dose of 8 mg dexamethasone before laparoscopic groin hernia repair had no clinical effect on early postoperative pain, discomfort or fatigue after TAPP inguinal hernia repair, but resulted in a significantly lower use of antiemetics in the PACU.

Early pain after laparoscopic inguinal hernia repair. A qualitative systematic review.

BACKGROUND: Early post-operative pain after laparoscopic groin hernia repair may, as in other laparoscopic operations, have its own individual pain pattern and patient-related predictors of early pain. The purpose of this review was to characterise pain within the first post-operative week after transabdominal pre-peritoneal repair (TAPP) and total extraperitoneal repair (TEP), and to identify patient-related predictors of early pain. METHODS: A qualitative systematic review was conducted. Pubmed, Embase, CINAHL, and the Cochrane database were searched for studies on early pain (first week) after TAPP or TEP. RESULTS: We included 71 eligible studies with 14,023 patients. Post-operative pain is most severe on day 0 and mainly on a level of 13-58 mm on a visual analogue scale and decreases to low levels on day 3. There seems to be no difference in pain intensity and duration when TEP and TAPP are compared. Deep abdominal pain (i.e. groin pain/visceral pain) dominates over superficial pain (i.e. somatic pain) and shoulder pain (i.e. referred pain) after TAPP. Predictors of early pain are young age and pre-operative high pain response to experimental heat stimulation. Furthermore, evidence supported early pain intensity as a predictive risk factor of chronic pain after laparoscopic groin hernia repair. CONCLUSION: Early pain within the first week after TAPP and TEP is most severe on the first post-operative day, and the pain pattern is dominated by deep abdominal pain. Early post-operative pain is most intense in younger patients and can be predicted by pre-operative high pain response to experimental heat stimulation.

Randomized clinical trial of fibrin sealant versus titanium tacks for mesh fixation in laparoscopic umbilical hernia repair.

BACKGROUND: The use of tacks for mesh fixation may induce pain after surgery for ventral hernia. The aim of this study was to compare postoperative pain after laparoscopic ventral hernia repair (LVHR) with conventional mesh fixation using titanium tacks versus fibrin sealant (FS). METHODS: This randomized clinical trial included patients with an umbilical hernia defect ranging from 1·5 to 5 cm at three Danish hernia centres. Participants were assigned randomly to FS or titanium tack fixation. The primary outcome was acute pain, defined as the mean pain score on days 0-2 after surgery, measured on a 0-100-mm visual analogue scale (VAS). RESULTS: Forty patients were included, of whom 38 were available for intention-to-treat analysis after 1 month. Patients in the FS group reported less pain than those in the tack group on days 0-2, both at rest (median 19 versus 47 mm; P = 0·025) and during activity (38 versus 60 mm; P = 0·014). The absolute difference in pain score between groups was 19 (95 per cent confidence interval 3 to 34) and 20 (4 to 35) mm at rest and during activity respectively. Patients in the FS group resumed normal daily activity earlier (after median 7 versus 18 days; P = 0·027) and reported significantly less discomfort. No recurrences were observed. CONCLUSION: Mesh fixation with FS in LVHR was associated with less acute postoperative pain, discomfort and a shorter convalescence than tack fixation. Long-term follow-up is needed to show whether the effect of FS fixation persists in terms of chronic pain and recurrence. REGISTRATION NUMBER: NCT00842842 (http://www.clinicaltrials.gov).

Nationwide Results on Chronic Pain After Bilateral Transabdominal Preperitoneal Inguinal Hernia Repair.

BACKGROUND: Majority of studies on chronic postoperative inguinal pain has described the occurrence after unilateral inguinal hernia repair. Endo-laparoscopic repair, for example, laparoscopic transabdominal preperitoneal inguinal hernia repair, has been recommended for primary bilateral symptomatic inguinal hernias, although the literature on chronic postoperative inguinal pain among this type of patients is limited. The present study analyzed chronic postoperative inguinal pain following bilateral transabdominal preperitoneal inguinal hernia repair. METHODS: Nationwide consecutive patients who underwent bilateral transabdominal preperitoneal inguinal hernia repair (July 2012-June 2013) were recruited from the Danish Inguinal Hernia Database and cross-checked with hospital files and the National Patient Registry. A prospective follow-up was performed with a standardized postal questionnaire including questions on functional performance status assessed by a modified version of the Activity Assessment Scale. The primary outcome was incidence of chronic postoperative inguinal pain defined as moderate to severe pain-related impairment of everyday activities. Pain was registered according to the two individual groin areas. Furthermore, the overall incidence of chronic postoperative inguinal pain per operated inguinal hernia was calculated. Intensity of experienced pain (Activity Assessment Scale score) was compared between patients reporting pain from one versus both groin areas. RESULTS: In total, 209 patients (418 hernia repairs) were analyzed (questionnaire response rate 83%). The median follow-up time was 27 months (22-34 months). In total, 27 of 209 patients (13%) complained of chronic postoperative inguinal pain from either one (n = 17) or both (n = 10) groin areas after bilateral transabdominal preperitoneal inguinal hernia repair. The incidence of chronic inguinal pain per operated hernia was 9%. The intensity of impairment due to pain (Activity Assessment Scale score) did not differ significantly between patients with chronic postoperative inguinal pain in one (19%) versus both sides (30%), p = 0.056. CONCLUSION: Bilateral transabdominal preperitoneal inguinal hernia repair for symptomatic inguinal hernias was related to a high incidence (13%) of chronic postoperative inguinal pain and decreased functional performance status.

Long-term patient-reported outcomes and quality of the evidence in ventral hernia mesh repair: a systematic review.

PURPOSE: Patient-reported outcome measures (PROMs) have been increasingly accepted to evaluate the quality of surgery. The impact of a hernia on PROMs and the indication for elective ventral hernia mesh repair are poorly researched. The primary objective in this systematic review was to provide evidence for PROM changes at least 3 months after elective ventral hernia mesh repair. Secondarily, a critical appraisal of the study quality was undertaken. METHODS: Ovid MEDLINE, PubMed, Ovid Embase, and CENTRAL were searched (year 2000-May 12, 2019) for studies reporting any of 21 predefined PROMs pre- and ≥ 3 months postoperatively following adult ventral hernia mesh repair. A pre-study defined analysis method was used to assess pre- vs. postoperative PROM changes. Quality assessment was guided by criteria formulated by the National Institutes of Health. RESULTS: The search yielded 11,438 potentially eligible studies of which 24 met the inclusion criteria. Most studies were of poor or moderate quality and one study was of high quality. There was no evidence for a clinically relevant postoperative improvement in any PROM following umbilical hernia repair or medium-sized incisional hernia repair. A clinically relevant postoperative improvement of pain, physical impairment, and social involvement was seen in patients with a large-sized incisional hernia repair and stoma-related complaints in patients with a medium-sized parastomal hernia repair. CONCLUSION: This analysis suggested that a minor subset of PROMs improved in patients undergoing large-sized incisional and medium-sized parastomal hernia repair. High-quality studies are imperative in this extremely often conducted surgical procedure. TRIAL REGISTRATION: The review was registered at PROSPERO (CRD42018096671, https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=96671 ).

Incisional hernia repair in women of childbearing age: A nationwide propensity-score matched study.

BACKGROUND & AIMS: Although incisional hernia repair in women of childbearing age is not rare, hernia disease in this group of patients is sparsely documented. The aim of this study was to examine long-term clinical results after incisional hernia repair in women of childbearing age. MATERIAL AND METHODS: This nationwide cohort study examined incisional hernia repair from 2007 to 2013 in women of childbearing age, registered prospectively in the Danish Ventral Hernia Database. All women with a subsequent pregnancy were included, and a 1:3 propensity-score matched group of women with an incisional hernia repair without a subsequent pregnancy. A prospective follow-up was conducted, including a validated questionnaire. The primary outcome was recurrence, and the secondary outcome was chronic pain from the operated site. RESULTS: In total, 124 (70.5%) women responded, 47 and 77 women with and without a subsequent pregnancy, respectively. The 5-year cumulative incidence of recurrence was 41.0% (95% confidence interval 32.0%-49.9%). After adjustment for potential confounders, subsequent pregnancy was independently associated with recurrence (hazard ratio 1.83, 95% confidence interval 1.02-3.29, p = 0.044). Twenty-six (21.0%) women reported chronic pain (moderate, n = 21; severe, n = 5) with no difference between women with and without a subsequent pregnancy. Hernia recurrence, higher body mass index, and smoking were associated with chronic pain. CONCLUSION: Pregnancy following incisional hernia repair was associated with an increased risk of recurrence, but not with chronic pain.

Re-recurrence and pain 12 years after laparoscopic transabdominal preperitoneal (TAPP) or Lichtenstein's repair for a recurrent inguinal hernia: a multi-centre single-blinded randomised clinical trial.

BACKGROUND: Long-term clinical outcome after a recurrent inguinal hernia repair may be associated with the type of repair, that is, laparoscopic or open. The results from previous randomised controlled trials are inconclusive regarding the long-term risk of re-recurrence chronic pain. Accordingly, this trial compared laparoscopic transabdominal preperitoneal repair (TAPP) with Lichtenstein's repair. The primary outcome was repair for a re-recurrence. The secondary outcome was chronic pain. METHODS: Multi-centre single-blinded, randomised trial on TAPP vs Lichtenstein's repair in male patients operated for a recurrent inguinal hernia after a primary open inguinal hernia repair. Follow-up for repair for a re-recurrence was registered in the Danish Hernia Database. Prospective follow-up data were achieved by a structured questionnaire on pain-related functional impairment using the Activities Assessment Scale (AAS-pain). RESULT: A total of 360 patients were randomised, 297 were mailed the follow-up questionnaire (63 excluded) after median 12 years (range 9-15). A total of 265 patients responded to the questionnaire (response rate 89%). The cumulative rate of repair for re-recurrence after 12 years was 10% (95% confidence interval (CI) 5.3-15.1%) vs 10% (5.6-14.7%) after TAPP or Lichtenstein, respectively (p = 0.764). Moderate/severe AAS-pain was reported by 4% (95% CI 1-8%) vs 7% (95% CI 3-11%) patients after TAPP or Lichtenstein, respectively (p = 0.698) CONCLUSION: Long-term re-recurrence rate and incidence of chronic pain was surprisingly high respectless of surgical approach and neither TAPP nor Lichtenstein's procedure was superior to improve surgical results.

Nationwide study of early outcomes after incisional hernia repair.

BACKGROUND: There are no nationwide studies on early outcomes after incisional hernia repair. METHODS: This study included all patients aged 18 years or more who had surgery for incisional hernia in Denmark between 1 January 2005 and 31 December 2006, and analysed clinical outcomes within 30 days of surgery. Patients having acute operations and those whose hernia repair was secondary to other procedures were excluded. RESULTS: Of a total of 2896 incisional hernia repairs (1872 open, 1024 laparoscopic), 2754 (95.1 per cent) were for primary hernia and 142 (4.9 per cent) for recurrence. The median hospital stay was 1 (range 0-88) day (open, 1 day; laparoscopic, 2 days); 10.0 per cent stayed for more than 6 days. Some 11.2 per cent of patients were readmitted (open, 10.1 per cent; laparoscopic, 13.1 per cent). Major complications were observed in 3.5 per cent (open, 2.8 per cent; laparoscopic, 4.8 per cent) with a total morbidity rate of 10.7 per cent (open, 10.1 per cent; laparoscopic, 11.8 per cent). The mortality rate was 0.4 per cent (open, 0.2 per cent; laparoscopic, 0.7 per cent). Morbidity and mortality were not related to surgical volume. CONCLUSION: Outcomes after incisional hernia repair seem unsatisfactory.