Open versus laparoscopic umbilical and epigastric hernia repair: nationwide data on short- and long-term outcomes.

BACKGROUND: It is unclear whether an open or laparoscopic approach results in the best outcomes for repair of umbilical and epigastric hernias. The aim of the study was to evaluate the rates of 90-day readmission and reoperation for complication, together with rate of operation for recurrence after either open or laparoscopic mesh repair for primary umbilical or epigastric hernias with defect widths above 1 cm. METHODS: A merge of data between the Danish Hernia Database and the National Patient Registry provided data from 2007 to 2018 on perioperative information, 90-day readmission, 90-day reoperation for complication, and long-term operation for hernia recurrence. RESULTS: A total of 6855 patients were included, of whom 4106 (59.9%) and 2749 (40.1%) patients had an open or laparoscopic repair, respectively. There were significantly more patients readmitted with a superficial surgical site infection 2.5% (102/4106) after open repair compared with laparoscopic repair (0.5% (15/2749), P < 0.001. The 90-day reoperation rate for complications was significantly higher for open repairs 5.0% (205/4106) compared with laparoscopic repairs 2.7% (75/2749), P < 0.001. The incidence of a reoperation for a severe condition was significantly increased after laparoscopic repair 1.5% (41/2749) compared with open repair 0.8% (34/4106), P = 0.010. The 4-year cumulative incidence of operation for hernia recurrence was 3.5% after open and 4.2% after laparoscopic repairs, P = 0.302. CONCLUSIONS: Recurrence rates were comparable between open and laparoscopic repair of umbilical and epigastric hernias. Open repair was associated with a significantly higher rate of readmission and reoperation due to surgical site infection, whereas the rate of reoperation due to a severe complication was significantly higher after laparoscopic repair.

Randomized clinical trial on closure versus non-closure of mesenteric defects during laparoscopic gastric bypass surgery.

BACKGROUND: Internal herniation is a well known and potentially life-threatening complication of laparoscopic Roux-en-Y gastric bypass (LRYGB). The aim of this study was to evaluate the benefit and harm of closing the mesenteric defects with clips during LRYGB to prevent internal herniation. METHODS: This was a single-centre, single-blinded RCT. Patients eligible for LRYGB were randomized to surgery with or without closure of mesenteric defects with clips. The primary endpoint was the incidence of (intermittent) internal herniation after LRYGB with a minimum follow-up of 24 months. Secondary outcomes were duration of surgery, number of clips used, trocars and sutures used, postoperative pain measured by a visual analogue scale (VAS), and postoperative complications. RESULTS: Between 13 August 2012 and 18 May 2017, 401 patients were randomized to closure (201) or non-closure (200) of mesenteric defects. Median follow-up for both groups was 59 months (range 8-67 and 16-67 months in non-closure and closure groups respectively). The cumulated risk of internal herniation after 2 years was 8.0 per cent in the non-closure group compared with 4.5 per cent in the closure group (hazard ratio (HR) 1.81, 95 per cent c.i. 0.80 to 4.12; P = 0.231). At 5 years, rates were 15.5 and 6.5 per cent respectively (HR 2.52, 1.32 to 4.81; P = 0.005). Closure of mesenteric defects increased operating time by a median of 4 min (95 per cent c.i. 52 to 56 min for the non-closure group and 56 to 60 min for the closure group; P = 0.002). There was no difference in postoperative blood transfusion rates and VAS scores between the groups. CONCLUSION: Routine closure of the mesenteric defects in LRYGB with clips is associated with a lower rate of internal herniation. Registration number: NCT01595230 (http://www.clinicaltrials.gov).

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).

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.

Surgical repair of parastomal bulging: a retrospective register-based study on prospectively collected data.

AIM: The aim of this work was to examine (1) the incidence of primary repair, (2) the incidence of recurrent repair and (3) the types of repair performed in patients with parastomal bulging. METHOD: Prospectively collected data on parastomal bulging from the Danish Stoma Database were linked to surgical data on repair of parastomal bulging from the Danish National Patient Register. Survival statistics provided cumulative incidences and time until primary and recurrent repair. RESULTS: In the study sample of 1016 patients with a permanent stoma and a parastomal bulge, 180 (18%) underwent surgical repair. The cumulative incidence of a primary repair was 9% [95% CI (8%; 11%)] within 1 year and 19% [95% CI (17%; 22%)] within 5 years after the occurrence of a parastomal bulge. We found a similar probability of undergoing primary repair in patients with ileostomy and colostomy. For recurrent repair, the 5-year cumulative incidence was 5% [95% CI (3%; 7%)]. In patients undergoing repair, the probability was 33% [95% CI (21%; 46%)] of having a recurrence requiring repair within 5 years. The main primary repair was open or laparoscopic repair with mesh (43%) followed by stoma revision (39%). Stoma revision and repair with mesh could precede or follow one another as primary and recurrent repair. Stoma reversal was performed in 17% of patients. CONCLUSION: Five years after the occurrence of a parastomal bulge the estimated probability of undergoing a repair was 19%. Having undergone a primary repair, the probability of recurrent repair was high. Stoma reversal was more common than expected.

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).

Short-term outcomes after open versus robot-assisted repair of ventral hernias: a nationwide database study.

PURPOSE: The robotic platform is widely implemented; however, evidence evaluating outcomes of robotic ventral hernia repair is still lacking. The aim of the study was to evaluate the short-term outcomes after open and robot-assisted repair of primary ventral and incisional hernias. METHODS: Nationwide register-based cohort study with data from the Danish Ventral Hernia Database and the National Danish Patients Registry was from January 1, 2017 to August 22, 2022. Robot-assisted ventral hernia repairs were propensity score matched 1:3 with open repairs according to the confounding variables defect size, Charlson comorbidity index score, and age. Logistic regression analyses were performed for factors associated with length of stay > 2 days, readmission, and reoperation within 90 days. RESULTS: A total of 528 and 1521 patients underwent robot-assisted and open repair, respectively. The mean length of hospital stay in days was 0.5 versus 2.1 for robot-assisted and open approach, respectively (P < 0.001) and open approach was correlated with risk of length of stay > 2 days (OR 23.25, CI 13.80-39.17, P < 0.001). The incidence of readmission within 90 days of discharge was significantly lower after robot-assisted repair compared to open approach (6.2% vs. 12.1%, P < 0.001). Open approach was independently associated with increased risk of readmission (OR 21.43, CI 13.28-39.17, P = 0.005, P < 0.001). CONCLUSION: Robot-assisted ventral hernia repair is safe and feasible and associated with shorter length of stay and decreased risk of readmission compared with open ventral hernia repair.

Repair of umbilical hernias concomitant to other procedures is safe: a propensity score-matched database study.

BACKGROUND: Repair of an umbilical hernia is most often considered the less important condition when concomitant with other abdominal surgery. Despite this, the evidence for a concomitant umbilical hernia repair is sparse. The aim of this nationwide cohort study is to compare the short- and long-term outcomes of primary umbilical hernia repair and umbilical hernia repair concomitant with other abdominal surgery. METHOD: Data from the Danish Hernia Database and the National Patients Registry from January 2007 to December 2018 was merged, resulting in identification of patients receiving umbilical hernia concomitant to another abdominal surgery (laparoscopic inguinal hernia repair, laparoscopic cholecystectomy, and laparoscopic appendectomy). This group was propensity score matched with patients undergoing umbilical hernia repair as a primary procedure. Outcome data included 90-day readmission, 90-day reoperation, and operation for recurrence. RESULTS: A total of 3365 primary umbilical hernia repairs and 2418 umbilical hernia repairs concomitant to other abdominal surgery were included. Readmission (10.5%, 255/2418) and reoperation (3.8%, 93/2418) rates within 90 days were decreased for umbilical hernia repairs concomitant to other abdominal surgery, compared with primary umbilical hernia repairs (22.7%, 765/3365) and (10.5%, 255/3365), P < 0.001 and P < 0.001, respectively. The rate of operation for recurrence was significantly increased for primary repairs (4.2%, 141/3365), compared with repairs concomitant to other abdominal surgery (3.2%, 77/2418), P = 0.014. CONCLUSION: Outcome in umbilical hernia repair performed concomitant to laparoscopic inguinal hernia repair, elective or emergency laparoscopic cholecystectomy, or laparoscopic appendectomy is comparable to umbilical hernia repair without concomitant surgery.