Jens A. Halm

Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia.

Objective:The objective of this study was to determine the best treatment of incisional hernia, taking into account recurrence, complications, discomfort, cosmetic result, and patient satisfaction. Background:Long-term results of incisional hernia repair are lacking. Retrospective studies and the midterm results of this study indicate that mesh repair is superior to suture repair. However, many surgeons are still performing suture repair. Methods:Between 1992 and 1998, a multicenter trial was performed, in which 181 eligible patients with a primary or first-time recurrent midline incisional hernia were randomly assigned to suture or mesh repair. In 2003, follow-up was updated. Results:Median follow-up was 75 months for suture repair and 81 months for mesh repair patients. The 10-year cumulative rate of recurrence was 63% for suture repair and 32% for mesh repair (P < 0.001). Abdominal aneurysm (P = 0.01) and wound infection (P = 0.02) were identified as independent risk factors for recurrence. In patients with small incisional hernias, the recurrence rates were 67% after suture repair and 17% after mesh repair (P = 0.003). One hundred twenty-six patients completed long-term follow-up (median follow-up 98 months). In the mesh repair group, 17% suffered a complication, compared with 8% in the suture repair group (P = 0.17). Abdominal pain was more frequent in suture repair patients (P = 0.01), but there was no difference in scar pain, cosmetic result, and patient satisfaction. Conclusions:Mesh repair results in a lower recurrence rate and less abdominal pain and does not result in more complications than suture repair. Suture repair of incisional hernia should be abandoned.

Intraperitoneal polypropylene mesh hernia repair complicates subsequent abdominal surgery.

BackgroundProsthetic incisional hernia repair (PIHR) is superior to primary closure in preventing hernia recurrence. Serious complications have been associated with the use of prosthetic material. Complications of subsequent surgical interventions after prior PIHR in relation to its anatomical position were the objectives of this study.Patients and MethodsPatients who underwent subsequent laparotomy/laparoscopy after PIHR between January 1992 and February 2005 at our institution were evaluated. Intraperitoneal and preperitoneal mesh was related to complication rates after subsequent surgical interventions.ResultsSixty-six of 335 patients underwent re-laparotomy after PIHR. The perioperative course was complicated in 76% (30/39) of procedures with intraperitoneal placed grafts compared to 29% (8/27) of interventions with preperitoneally positioned meshes (P < 0.001). Small bowel resections were necessary in 21% of the intraperitoneal group (8/39) versus 0% in the preperitoneal group. Surgical site infection rates were higher in the intraperitoneal group (10/39, 26%, versus 1/27, 4%). Enterocutaneous fistula formation was rare and occurred in two patients after subsequent laparotomy (5%).ConclusionsRe-laparotomy after PIHR with polypropylene meshes are associated with more preoperative and postoperative complications when the mesh is placed intraperitoneally. Therefore 0intraperitoneal positioning of polypropylene mesh at incisional hernia repair should be avoided if possible.

Randomized Clinical Trial of Laparoscopic Versus Open Repair of the Perforated Peptic Ulcer: The LAMA Trial

BackgroundLaparoscopic surgery has become popular during the last decade, mainly because it is associated with fewer postoperative complications than the conventional open approach. It remains unclear, however, if this benefit is observed after laparoscopic correction of perforated peptic ulcer (PPU). The goal of the present study was to evaluate whether laparoscopic closure of a PPU is as safe as conventional open correction.MethodsThe study was based on a randomized controlled trial in which nine medical centers from the Netherlands participated. A total of 109 patients with symptoms of PPU and evidence of air under the diaphragm were scheduled to receive a PPU repair. After exclusion of 8 patients during the operation, outcomes were analyzed for laparotomy (nxa0=xa049) and for the laparoscopic procedure (nxa0=xa052).ResultsOperating time in the laparoscopy group was significantly longer than in the open group (75xa0min versus 50xa0min). Differences regarding postoperative dosage of opiates and the visual analog scale (VAS) for pain scoring system were in favor of the laparoscopic procedure. The VAS score on postoperative days 1, 3, and 7 was significant lower (Pxa0<xa00.05) in the laparoscopic group. Complications were equally distributed. Hospital stay was also comparable: 6.5xa0days in the laparoscopic group versus 8.0xa0days in the open group (Pxa0=xa00.235).ConclusionsLaparoscopic repair of PPU is a safe procedure compared with open repair. The results considering postoperative pain favor the laparoscopic procedure.

Long-term follow-up after umbilical hernia repair: are there risk factors for recurrence after simple and mesh repair

Adult umbilical hernia is a common surgical condition mainly encountered in the fifth and sixth decade of life. Despite the high frequency of the umbilical hernia repair procedure, disappointingly high recurrence rates, up to 54% for simple suture repair, are reported. Since both mesh and suture techniques are used in our clinic we set out to investigate the respective recurrence rates and associated complications, retrospectively. Patients who were treated between January 1998 and December 2002 were identified from our hospital database and invited to attend the outpatient department for an extra follow-up, history taking and physical examination. The use of prosthetic material, occurrence of surgical site infection, body mass and height as well as recurrence were recorded at the time of this survey. In total, 131 consecutive patients underwent operative repair of an umbilical hernia. Twenty-eight percent of the patients were female (n=37). In 12 patients (11%) umbilical hernia repair was achieved with mesh implantation. Fourteen umbilical hernia recurrences were noted (13%); none had been repaired using mesh. No relationship was found between wound infection or obesity and umbilical hernia recurrence. In the light of these results it is necessary to re-evaluate our clinical “guidelines” on mesh placement in umbilical hernia repair: apparently not every umbilical fascial defect needs mesh repair. Research should focus on establishing risk factors for hernia recurrence.

Provider and center effect in multicenter randomized controlled trials of surgical specialties: An analysis on patient-level data

Objective:To estimate the importance of center and provider effect and its implication on the estimation of treatment effect in surgical randomized controlled trials. Summary Background Data:Provider and center effect may play an important role in the estimated treatment effect of multicenter surgical randomized controlled trials (RCTs). However, such effects are rarely accounted for in surgical RCTs. Methods:Analysis of patient-level data from 3 large surgical randomized controlled trials. One trial in ophthalmology comparing retinal detachment rate after retinal reattachment in 225 patients operated on by 32 providers across 10 centers; one trial in orthopaedics comparing Harris Hip Score after total hip replacement in 496 patients operated on by 22 providers across 18 centers; one trial in general surgery comparing recurrence rate of hernia repair in 200 patients operated on by 88 providers across 11 centers. A provider effect and a center effect were searched for by comparing nonadjusted and adjusted models. An analysis of volume (ie, number of procedures performed during the course of the trial) effect and, when relevant, a treatment-by-volume interaction was also sought. Results:A significant provider effect was found in ophthalmology (P < 0.0001); center effect was not significant. In orthopaedics, significant provider (P = 0.0037) and volume effect (P = 0.019) were found; a correlation was found between provider effect and volume (r = 0.5, P = 0.018); moreover, a treatment-by-volume interaction was found (P = 0.033); treatment effect became significant when adjusting for volume and provider. In general surgery, center effect was more prominent than provider effect, although none were found significant. Conclusions:Provider and center effects play a significant role in the estimation of treatment effect of large randomized controlled surgical trials. Not accounting for such effects may lead to biased estimates and misleading conclusions. These effects should be accounted for in the design and analysis of such trials.

Treatment of penetrating trauma of the extremities: ten years' experience at a Dutch level 1 trauma center.

BackgroundA selective non-operative management (SNOM) has found to be an adequate and safe strategy to assess and treat patients suffering from penetrating trauma of the extremities (PTE). With this SNOM comes a strategy in which adjuvant investigations or interventions are not routinely performed, but based on physical examination only.MethodsAll subsequent patients presented with PTE at a Dutch level I trauma center from October 2000 to June 2011 were included in this study. In-hospital and long-term outcome was analysed in the light of assessment of these patients according to the SNOM protocol.ResultsA total of 668 patients (88.2% male; 33.8% gunshot wounds) with PTE presented at the Emergency Department of a level 1 traumacenter, of whom 156 were admitted for surgical treatment or observation. Overall, 22 (14%) patients that were admitted underwent exploration of the extremity for vascular injury. After conservative observation, two (1.5%) patients needed an intervention to treat (late onset) vascular complications. Other long-term extremity related complications were loss of function or other deformity (nu2009=u20099) due to missed nerve injury, including 2 patients with peroneal nerve injury caused by delayed compartment syndrome treatment.ConclusionA SNOM protocol for initial assessment and treatment of PTE is feasible and safe. Clinical examination of the injured extremity is a reliable diagnostic tool for excluding vascular injury. Repeated assessments for nerve injuries are important as these are the ones that are frequently missed and result in long-term disability. Level of evidence: II / III, retrospective prognostic observational cohort study Key words Penetrating trauma, extremity, vascular injury, complications.

Damage to the Superficial Peroneal Nerve in Operative Treatment of Fibula Fractures: Straight to the Bone? Case Report and Review of the Literature

Ankle fractures are a significant part of the lower extremity trauma seen in the emergency department. Neurologic complications of ankle fracture surgery are infrequently described but account for significant morbidity. The risk of nerve injury is increased for the Blair and Botte type B pattern of the intermediate cutaneous dorsal nerve branch, crossing the distal fibula from posterior to anterior (at 5 to 7 cm from malleolar tip). This pattern is present in about 10% to 15% of patients. Injuries to the superficial peroneal nerve and its branches negatively influence the outcome. Early recognition and protection might reduce the incidence of superficial peroneal nerve injuries during open reduction and internal fixation of lateral malleolus fractures. We describe 2 surgically treated ankle fractures with superficial peroneal nerve branch (intermediate cutaneous dorsal nerve) involvement and review the current literature.

The fate of Bohler's angle in conservatively-treated displaced intra-articular calcaneal fractures

PurposeAlthough the predictive value of Böhler’s angle on outcome remains subject of debate, the initial angle at the time of trauma still guides treatment. Changes in Böhler’s angle during follow-up are frequently reported following surgical treatment of displaced intra-articular calcaneal fractures (DIACF). The aim of the present study was to determine the changes in Böhler’s angle as a measure of secondary fracture displacement following conservative management of DIACF.MethodsThirty-eight patients with a total of 44 displaced intra-articular calcaneal fractures treated conservatively with a minimum of two lateral radiographs during follow-up were analysed. Böhler’s angle at different follow-up times was measured by three observers. The change in angle was compared with the angle at trauma, and influence of trauma mechanism and common calcaneal fracture classifications were determined.ResultsThe results showed a significant decline over time of the Böhler’s angle in conservatively-treated patients of more than 11° on average at a mean follow-up of 29.2xa0weeks. This decrease was not related to gender, the initial angle, or the Essex-Lopresti or Sanders classification. A statistically significantly higher decrease was detected in high energetic trauma compared with low energetic trauma.ConclusionThe conservative treatment of displaced intra-articular calcaneal fractures is still a viable option, yet a significant secondary displacement in time should be taken into account, as reflected in a decrease of Böhler’s angle of 11° up to onexa0year following trauma.

Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial

BACKGROUNDnBoth mesh and suture repair are used for the treatment of umbilical hernias, but for smaller umbilical hernias (diameter 1-4 cm) there is little evidence whether mesh repair would be beneficial. In this study we aimed to investigate whether use of a mesh was better in reducing recurrence compared with suture repair for smaller umbilical hernias.nnnMETHODSnWe did a randomised, double-blind, controlled multicentre trial in 12 hospitals (nine in the Netherlands, two in Germany, and one in Italy). Eligible participants were adults aged at least 18 years with a primary umbilical hernia of diameter 1-4 cm, and were randomly assigned (1:1) intraoperatively to either suture repair or mesh repair. In the first 3 years of the inclusion period, blocked randomisation (of non-specified size) was achieved by an envelope randomisation system; after this time computer-generated randomisation was introduced. Patients, investigators, and analysts were masked to the allocated treatment, and participants were stratified by hernia size (1-2 cm and >2-4 cm). At study initiation, all surgeons were invited to training sessions to ensure they used the same standardised techniques for suture repair or mesh repair. Patients underwent physical examinations at 2 weeks, and 3, 12, and 24-30 months after the operation. The primary outcome was the rate of recurrences of the umbilical hernia after 24 months assessed in the modified intention-to-treat population by physical examination and, in case of any doubt, abdominal ultrasound. This trial is registered with ClinicalTrials.gov, number NCT00789230.nnnFINDINGSnBetween June 21, 2006, and April 16, 2014, we randomly assigned 300 patients, 150 to mesh repair and 150 to suture repair. The median follow-up was 25·1 months (IQR 15·5-33·4). After a maximum follow-up of 30 months, there were fewer recurrences in the mesh group than in the suture group (six [4%] in 146 patients vs 17 [12%] in 138 patients; 2-year actuarial estimates of recurrence 3·6% [95% CI 1·4-9·4] vs 11·4% (6·8-18·9); p=0·01, hazard ratio 0·31, 95% CI 0·12-0·80, corresponding to a number needed to treat of 12·8). The most common postoperative complications were seroma (one [<1%] in the suture group vs five [3%] in the mesh group), haematoma (two [1%] vs three [2%]), and wound infection (one [<1%] vs three [2%]). There were no anaesthetic complications or postoperative deaths.nnnINTERPRETATIONnThis is the first study showing high level evidence for mesh repair in patients with small hernias of diameter 1-4 cm. Hence we suggest mesh repair should be used for operations on all patients with an umbilical hernia of this size.nnnFUNDINGnDepartment of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.

Management of penetrating injuries of the upper extremities.

BACKGROUNDnRoutine surgical exploration after penetrating upper extremity trauma (PUET) to exclude arterial injury leads to a large number of negative explorations and iatrogenic injuries. Selective non-operative management (SNOM) is gaining in favor for patients with PUET. The present study was undertaken to assess the validity of SNOM in PUET and to present a practical management algorithm.nnnMETHODSnAll consecutive patients presenting to a tertiary referral center following PUET were included in this prospective observational cohort study. Patients were managed along Advanced Trauma Life Support (ATLS©) guidelines, and based on clinical manifestations, either underwent emergency surgery or were treated conservatively with or without additional diagnostic investigations. Computed tomography angiography (CTA) was indicated by a preset protocol based on the physical examination.nnnRESULTSnDuring the four-month study period, 161 patients with PUET were admitted. Sixteen (9.9%) patients underwent emergency surgery, revealing 14 vascular injuries. Another 8 (5.0%) patients underwent vascular exploration following CTA. The remaining patients (n=137) were managed non-operatively for vascular matters. Eighteen (11.2%) patients required semi-elective surgical intervention for fractures or nerve injuries. During the follow- up, no missed vascular injuries were detected.nnnCONCLUSIONnNeither routine exploration nor routine CTA is indicated after PUET. Stable patients should undergo additional investigation based on clinical findings only. SNOM is a feasible and safe strategy after PUET.