Recommendations for reporting outcome results in abdominal wall repair: results of a Consensus meeting in Palermo, Italy, 28-30 June 2012.

BACKGROUND: The literature dealing with abdominal wall surgery is often flawed due to lack of adherence to accepted reporting standards and statistical methodology. MATERIALS AND METHODS: The EuraHS Working Group (European Registry of Abdominal Wall Hernias) organised a consensus meeting of surgical experts and researchers with an interest in abdominal wall surgery, including a statistician, the editors of the journal Hernia and scientists experienced in meta-analysis. Detailed discussions took place to identify the basic ground rules necessary to improve the quality of research reports related to abdominal wall reconstruction. RESULTS: A list of recommendations was formulated including more general issues on the scientific methodology and statistical approach. Standards and statements are available, each depending on the type of study that is being reported: the CONSORT statement for the Randomised Controlled Trials, the TREND statement for non randomised interventional studies, the STROBE statement for observational studies, the STARLITE statement for literature searches, the MOOSE statement for metaanalyses of observational studies and the PRISMA statement for systematic reviews and meta-analyses. A number of recommendations were made, including the use of previously published standard definitions and classifications relating to hernia variables and treatment; the use of the validated Clavien-Dindo classification to report complications in hernia surgery; the use of "time-to-event analysis" to report data on "freedom-of-recurrence" rather than the use of recurrence rates, because it is more sensitive and accounts for the patients that are lost to follow-up compared with other reporting methods. CONCLUSION: A set of recommendations for reporting outcome results of abdominal wall surgery was formulated as guidance for researchers. It is anticipated that the use of these recommendations will increase the quality and meaning of abdominal wall surgery research.

EuraHS: the development of an international online platform for registration and outcome measurement of ventral abdominal wall hernia repair.

BACKGROUND: Although the repair of ventral abdominal wall hernias is one of the most commonly performed operations, many aspects of their treatment are still under debate or poorly studied. In addition, there is a lack of good definitions and classifications that make the evaluation of studies and meta-analyses in this field of surgery difficult. MATERIALS AND METHODS: Under the auspices of the board of the European Hernia Society and following the previously published classifications on inguinal and on ventral hernias, a working group was formed to create an online platform for registration and outcome measurement of operations for ventral abdominal wall hernias. Development of such a registry involved reaching agreement about clear definitions and classifications on patient variables, surgical procedures and mesh materials used, as well as outcome parameters. The EuraHS working group (European registry for abdominal wall hernias) comprised of a multinational European expert panel with specific interest in abdominal wall hernias. Over five working group meetings, consensus was reached on definitions for the data to be recorded in the registry. RESULTS: A set of well-described definitions was made. The previously reported EHS classifications of hernias will be used. Risk factors for recurrences and co-morbidities of patients were listed. A new severity of comorbidity score was defined. Post-operative complications were classified according to existing classifications as described for other fields of surgery. A new 3-dimensional numerical quality-of-life score, EuraHS-QoL score, was defined. An online platform is created based on the definitions and classifications, which can be used by individual surgeons, surgical teams or for multicentre studies. A EuraHS website is constructed with easy access to all the definitions, classifications and results from the database. CONCLUSION: An online platform for registration and outcome measurement of abdominal wall hernia repairs with clear definitions and classifications is offered to the surgical community. It is hoped that this registry could lead to better evidence-based guidelines for treatment of abdominal wall hernias based on hernia variables, patient variables, available hernia repair materials and techniques.

Classification of primary and incisional abdominal wall hernias.

PURPOSE: A classification for primary and incisional abdominal wall hernias is needed to allow comparison of publications and future studies on these hernias. It is important to know whether the populations described in different studies are comparable. METHODS: Several members of the EHS board and some invitees gathered for 2 days to discuss the development of an EHS classification for primary and incisional abdominal wall hernias. RESULTS: To distinguish primary and incisional abdominal wall hernias, a separate classification based on localisation and size as the major risk factors was proposed. Further data are needed to define the optimal size variable for classification of incisional hernias in order to distinguish subgroups with differences in outcome. CONCLUSIONS: A classification for primary abdominal wall hernias and a division into subgroups for incisional abdominal wall hernias, concerning the localisation of the hernia, was formulated.

Routine surgical pathology in general surgery.

BACKGROUND: Although pathological analysis provides the definitive diagnosis for most resection specimens, recent evidence suggests that such analysis may be omitted for certain routine samples. This was a retrospective analysis of the value of routine histopathological examination performed in daily general surgical practice. METHODS: All specimens from routine appendicectomies, cholecystectomies, haemorrhoidectomies and inguinal hernia repairs performed between 1993 and 2002 were included. The analysis included a comparison of histological and macroscopic diagnoses, review of preoperative and peroperative findings, and an evaluation of the consequences of routine histopathological assessment on patient management and costs. RESULTS: With the exception of hernia specimens, the rate of submission for routine pathological evaluation was 100 per cent. No hernia sac specimen from more than 2000 interventions revealed aberrant histological findings. Of 311 haemorrhoidectomy specimens three showed malignancy, all of which had a suspicious macroscopic appearance. Of 1465 appendices, only one (0.1 per cent) had a potentially relevant histological diagnosis that was not suspected macroscopically. Among 1523 cholecystectomy specimens, all adenomas (0.6 per cent) and carcinomas (0.4 per cent) were suspected macroscopically or developed in association with a known disease. CONCLUSION: The rarity of incidental histological findings relevant to patient management, especially in the absence of macroscopic abnormalities, suggests that routine histological examination of certain specimens may be omitted. A more elementary role for macroscopic examination of the specimen by the surgeon and the pathologist is proposed.

Quality of life 2 years after laparoscopic total fundoplication: a prospective study.

This study was a prospective evaluation of the quality of life of 50 patients after laparoscopic total fundoplication surgery for gastroesophageal reflux disease. The quality of life of 50 consecutive patients who underwent laparoscopic total fundoplication was evaluated using the Gastrointestinal Quality of Life Index questionnaire, which included 36 items in five different areas: symptoms, physical well-being, psychologic well-being, social relationships, and effects of medical treatment. Twenty-seven men and 23 women with a mean age of 52.6 +/- 16 years (range, 31-68 years) with gastroesophageal reflux disease were treated by laparoscopic total fundoplication (Nissen-Rosetti) and were included in the study. The follow-up was at least 2 years after surgery. The quality of life was evaluated before the surgery and 1 month, 3 months, 6 months, 1 year, and 2 years after surgery with follow-up in 100% of the cases. A control group of 50 healthy volunteers representing an identical population to that of the patients operated on (with respect to age, sex, body mass index, profession, and smoking) anonymously completed the same questionnaire. The preoperative and postoperative Gastrointestinal Quality of Life Index questionnaire scores of patients who had laparoscopic total fundoplication were compared with the Gastrointestinal Quality of Life Index questionnaire scores of the control group. Before surgery, the Gastrointestinal Quality of Life Index questionnaire score (86.7 +/- 8.5) was much inferior to that of the control group (123.8 +/- 13.6) (P < 0.001). This score significantly improved 3 months after surgery and was comparable (not significant) to that of the healthy control population 3 months, 6 months, 1 year, and 2 years after surgery (119.3 +/- 7.8). Improvements were reported mainly with respect to gastrointestinal symptoms and physical well-being. Social relationships were not modified. The quality of life of patients after laparoscopic surgery for gastroesophageal reflux disease improved and was close to the level expected in a healthy individual.

Two-stage laparoscopic management of generalized peritonitis due to perforated sigmoid diverticula: eighteen cases.

The classic treatment of generalized peritonitis due to perforation of sigmoid diverticula is based on the principle of a two-stage surgery with a temporary derivation of the colonic transit. This procedure is associated with a prohibitively high immediate and delayed morbidity, especially associated with the abdominal wound. The laparoscopic approach to this complication is less aggressive and allows a second-stage elective laparoscopic resection. Eighteen consecutive patients (ten women and eight men; average age, 53.7 years) underwent emergency laparoscopic treatment for generalized peritonitis due to perforated diverticula. Eight of these patients had previously had diverticulitis attacks. By peritoneal cavity exploration and full peritoneal lavage (average, 15 L), the infected sigmoid lesion was stuck with biologic glue. A drain was inserted at the site of the lesion and in some cases also in other abdominal zones. No colostomy was necessary. Antibiotic treatment was started at diagnosis and continued for a minimum of 7 days. There was no mortality. Morbidity was limited to three patients (two cases of lymphangitis and one of pulmonary disease). No patient had a wound abscess or residual deep collections. The mean hospitalization was 8 days. Fourteen patients underwent elective laparoscopic sigmoid resection with a delay of 3.5 months. One conversion to laparotomy was necessary. The laparoscopic treatment of generalized peritonitis due to perforated sigmoid diverticula is an interesting alternative to the traditional treatment. It is associated with a lower morbidity, a shorter postoperative hospital stay, and an improvement in the patient's quality of life, because colostomy is avoided. It is also associated with economic savings.

Does laparoscopy reduce the incidence of unnecessary appendicectomies?

The aim of this study was to evaluate the impact of laparoscopic appendicectomy on the incidence of histologically normal appendices. Between 1987 and 1997, 1,220 patients (average age 23.5 years [17-73]; 841 women [69%]) had appendicectomy due to the presence of at least one of the following three criteria: right iliac fossa guarding, fever >38 degrees C, and leukocytosis >10,000. Patients were divided into two groups: one group of 930 patients were operated on using the classic Mac Burney approach and the other group of 355 patients underwent laparoscopic exploration, with an appendicectomy performed if macroscopic abnormalities were observed (290 cases). In all cases, the appendices were examined blind and classified as normal or pathologic, with the latter divided with respect to the nature and severity of the lesions. In the Mac Burney group, the incidence of histologically normal appendices was 25.1%. In the laparoscopic group, the incidence was only 8.2% (p=0.015). The types of pathologic appendices were identical between the two groups. In 65 cases (18.3%), a macroscopically normal appendix was left in place. In 56 cases the symptoms were due to another identified cause, however, in 10 cases no cause was found. All patients were followed-up for an average of 3 years. One patient (1.8%) had a second operation (an appendicectomy), which revealed minor histologic lesions. The problem is the inability of the operator to differentiate between a healthy and a pathologic appendix on laparoscopy. The risk of false-positives and false-negatives is approximately 10%. Diagnostic difficulties usually occur in the initial phase of the disease with acute mucosal involvement in a morphologically normal appendix. At this stage the outcome cannot be predicted, although appropriate antibiotic treatment can be effective. This study shows that laparoscopy significantly reduces the number of histologically normal appendices as compared to a conventional Mac Burney operation. This can only be achieved by not removing macroscopically normal appendices, a small proportion of which (5-10%) could be cases of early appendicitis with only mucosal involvement. In the absence of other causes of the symptoms, a 3-day course of antibiotics can be tried to treat possible mucosal lesions. This approach reduces costs without having adverse consequences on the outcome.

The effect of the learning curve on the outcome of laparoscopic treatment for gastroesophageal reflux.

The laparoscopic treatment for gastroesophageal reflux (GR) by partial (PF) or total (TF) fundoplication is the current surgical treatment of choice after failure of appropriate medical treatment. The overall results with fundoplication include the initial learning period, during which the rate of complications, conversions, and duration of surgery and hospitalization are assumed to be greater. The aim of this study was to compare the results of laparoscopic treatment for GR in three groups of consecutive patients to determine the effect of the learning period on outcome. One hundred and fifty-six patients (88 men and 68 women) with an average age of 52.3 years (range, 18-78) were included. Surgery was indicated for failure or early relapse after the end of medical treatment or a symptomatic sliding hernia. The preoperative workup (endoscopy, barium meal, or esophageal pH monitoring) was governed by the clinical picture. The choice between TF and PF was based on the results of pH monitoring. Three groups of patients were chronologically defined. The parameters that were examined were the type of preoperative exploration, the type of fundoplication, the operative technique, the conversion rate, the mortality and morbidity rates, the duration of surgery and hospitalization, and the results at short- and medium-term follow-up. The three groups were comparable with respect to patient characteristics and the nature of their GR. All patients had an endoscopy, 91% had a barium meal, 77.5% underwent esophageal manometry, and 67% had pH monitoring. One hundred and thirty-six patients had a TF and 20 had a PF. Rossetti type TF became the reference procedure (67% in group III) and closure of the diaphragmatic crura was performed systematically in group III (100%). The duration of surgery was significantly reduced between groups I and groups II and III (140, 100, 80 minutes, respectively). The rate of conversion, due to a variety of causes, decreased from 9.8% to 3.8%, and then to 0%. The average duration of hospitalization decreased from 5.8 to 4.2 days (p = 0.01). There was no mortality and the morbidity rate decreased from 15% to 3.8%, and then to 0%. There were seven cases of relapse (4.6%), five in group I (10%) and two in group II (4%), with no cases in group III, although the follow-up in group III was shorter. There is an effect of the learning curve on the outcome of treatment for GR, and this must be taken into account in the training of surgeons (training within experienced departments and guidance during their initial interventions) and also in publications to allow a more accurate comparison of this technique with other treatments for GR.

Inguinal hernia repair: totally preperitoneal laparoscopic approach versus Stoppa operation: randomized trial of 100 cases.

In a prospective randomized trial comparing the totally preperitoneal (TPP) laparoscopic approach and the Stoppa procedure (open), 100 patients with inguinal hernias (Nyhus IIIA, IIIB, IV) were followed over a 3-year period. Both groups were epidemiologically comparable. In the laparoscopic group, operating time was significantly longer (p = 0.01), but hospital stay (3.2 vs. 7.3 days) and delay in return to work (17 vs. 35 days) were significantly reduced (p = 0.01). Postoperative comfort (less pain) was better (p = 0.001) after laparoscopy. In this group, morbidity was also reduced (4 vs. 20%; p = 0.02). The mean follow-up was 605 days, and 93% of the patients were reviewed at 3 years. There were three (6%) recurrences after TPP, especially at the beginning of the surgeon's learning curve, versus one for the Stoppa procedure (NS). For bilateral hernias, the authors suggest the use of a large prosthesis rather than two small ones to minimize the likelihood of recurrence. In the conditions described, the laparoscopic (TPP) approach to inguinal hernia treatment appears to have the same long-term recurrence rate as the open (Stoppa) procedure but a real advantage in the early postoperative period.

Laparoscopic treatment of perforated peptic ulcer.

The technique of laparoscopic repair of perforated duodenal ulcers is described. Most patients have had a suture of the edge of the perforation and an omental patch. Laparoscopy allows a complete wash-out of the peritoneal cavity. There is no mortality. Early mobilisation and discharge from the hospital (5-8 days) are notable features. The possibility of simultaneous laparoscopic treatment of the perforation and the ulcer diathesis is discussed.