Gabrielle H. van Ramshorst

Small bites versus large bites for closure of abdominal midline incisions (STITCH): A double-blind, multicentre, randomised controlled trial

BACKGROUND Incisional hernia is a frequent complication of midline laparotomy and is associated with high morbidity, decreased quality of life, and high costs. We aimed to compare the large bites suture technique with the small bites technique for fascial closure of midline laparotomy incisions. METHODS We did this prospective, multicentre, double-blind, randomised controlled trial at surgical and gynaecological departments in ten hospitals in the Netherlands. Patients aged 18 years or older who were scheduled to undergo elective abdominal surgery with midline laparotomy were randomly assigned (1:1), via a computer-generated randomisation sequence, to receive small tissue bites of 5 mm every 5 mm or large bites of 1 cm every 1 cm. Randomisation was stratified by centre and between surgeons and residents with a minimisation procedure to ensure balanced allocation. Patients and study investigators were masked to group allocation. The primary outcome was the occurrence of incisional hernia; we postulated a reduced incidence in the small bites group. We analysed patients by intention to treat. This trial is registered at Clinicaltrials.gov, number NCT01132209 and with the Nederlands Trial Register, number NTR2052. FINDINGS Between Oct 20, 2009, and March 12, 2012, we randomly assigned 560 patients to the large bites group (n=284) or the small bites group (n=276). Follow-up ended on Aug 30, 2013; 545 (97%) patients completed follow-up and were included in the primary outcome analysis. Patients in the small bites group had fascial closures sutured with more stitches than those in the large bites group (mean number of stitches 45 [SD 12] vs 25 [10]; p<0·0001), a higher ratio of suture length to wound length (5·0 [1·5] vs 4·3 [1·4]; p<0·0001) and a longer closure time (14 [6] vs 10 [4] min; p<0·0001). At 1 year follow-up, 57 (21%) of 277 patients in the large bites group and 35 (13%) of 268 patients in the small bites group had incisional hernia (p=0·0220, covariate adjusted odds ratio 0·52, 95% CI 0·31-0·87; p=0·0131). Rates of adverse events did not differ significantly between groups. INTERPRETATION Our findings show that the small bites suture technique is more effective than the traditional large bites technique for prevention of incisional hernia in midline incisions and is not associated with a higher rate of adverse events. The small bites technique should become the standard closure technique for midline incisions. FUNDING Erasmus University Medical Center and Ethicon.

Impact of incisional hernia on health-related quality of life and body image: a prospective cohort study

BACKGROUND We investigated the impact of incisional hernia (IH) on quality of life and body image. METHODS Open abdominal surgery patients were included in a prospective cohort study performed between 2007 and 2009 in an academic hospital. Main outcomes were incidence of IH after approximately 12 months and Short-Form 36 and body image questionnaire results. RESULTS There were 374 patients who were examined after a median follow-up period of 16 months (range, 10-24 mo). Seventy-five patients had developed IH (20%); 63 (84%) were symptomatic. Adjusted for age, sex, and Charlson Comorbidity Index score, patients with IH reported significantly lower mean scores for components physical functioning (P = .033), role physical (P = .002), and physical component summary (P = .010). A trend toward significance was found for general health (P = .061). Patients with IH reported significantly lower mean cosmetic scores (P = .002), and body image and total body image scores (both P < .001). CONCLUSIONS Patients with IH reported lower mean scores on physical components of health-related quality of life and body image.

Small stitches with small suture distances increase laparotomy closure strength.

BACKGROUND There is no conclusive evidence which size of suture stitches and suture distance should be used to prevent burst abdomen and incisional hernia. METHODS Thirty-eight porcine abdominal walls were removed immediately after death and divided into 2 groups: A and B (N = 19 each). Two suturing methods using double-loop polydioxanone were tested in 14-cm midline incisions: group A consisted of large stitches (1 cm) with a large suture distance (1 cm), and group B consisted of small stitches (.5 cm) with a small suture distance (.5 cm). RESULTS The geometric mean tensile force in group B was significantly higher than in group A (787 N vs 534 N; P = .006). CONCLUSIONS Small stitches with small suture distances achieve higher tensile forces than large stitches with large suture distances. Therefore, small stitches may be useful to prevent the development of a burst abdomen or an incisional hernia after midline incisions.

A multicenter randomized controlled trial evaluating the effect of small stitches on the incidence of incisional hernia in midline incisions

BackgroundThe median laparotomy is frequently used by abdominal surgeons to gain rapid and wide access to the abdominal cavity with minimal damage to nerves, vascular structures and muscles of the abdominal wall. However, incisional hernia remains the most common complication after median laparotomy, with reported incidences varying between 2-20%. Recent clinical and experimental data showed a continuous suture technique with many small tissue bites in the aponeurosis only, is possibly more effective in the prevention of incisional hernia when compared to the common used large bite technique or mass closure.Methods/DesignThe STITCH trial is a double-blinded multicenter randomized controlled trial designed to compare a standardized large bite technique with a standardized small bites technique. The main objective is to compare both suture techniques for incidence of incisional hernia after one year. Secondary outcomes will include postoperative complications, direct costs, indirect costs and quality of life.A total of 576 patients will be randomized between a standardized small bites or large bites technique. At least 10 departments of general surgery and two departments of oncological gynaecology will participate in this trial. Both techniques have a standardized amount of stitches per cm wound length and suture length wound length ratios are calculated in each patient. Follow up will be at 1 month for wound infection and 1 year for incisional hernia. Ultrasound examinations will be performed at both time points to measure the distance between the rectus muscles (at 3 points) and to objectify presence or absence of incisional hernia. Patients, investigators and radiologists will be blinded during follow up, although the surgeon can not be blinded during the surgical procedure.ConclusionThe STITCH trial will provide level 1b evidence to support the preference for either a continuous suture technique with many small tissue bites in the aponeurosis only or for the commonly used large bites technique.Trial registrationClinicaltrials.gov NCT01132209

Noninvasive Assessment of Intra-Abdominal Pressure by Measurement of Abdominal Wall Tension

BACKGROUND Sustained increased intra-abdominal pressure (IAP) has negative effects. Noninvasive IAP measurement could be beneficial to improve monitoring of patients at risk and in whom IAP measurements might be unreliable. We assessed the relation between IAP and abdominal wall tension (AWT) in vitro and in vivo. MATERIALS AND METHODS The abdomens of 14 corpses were insufflated with air. IAP was measured at intervals up to 20 mm Hg. At each interval, AWT was measured five times at six points. In 42 volunteers, AWT was measured at five points in supine, sitting, and standing positions during various respiratory manoeuvres. Series were repeated in 14 volunteers to measure reproducibility by calculating coefficients of variation (CV). ANOVA was used for analyses. RESULTS In corpses, all points showed significant correlations between IAP and AWT (P < 0.001 for points 1-4 in the upper abdomen, P = 0.017 for point 5 and P = 0.008 for point 6 in the lower abdomen). Mean slopes were greatest at points across the epigastric region (points 1-3). In vivo measurements showed that AWT was on average 31% higher in men compared to women (P < 0.001), and increased from expiration to inspiration to Valsalvas manoeuvre (all P < 0.001). AWT was highest at points 1 and 2 and in standing position, followed by supine and sitting positions. BMI did not influence AWT. Mean CV of repeated measurements was 14%. CONCLUSIONS AWT reflects IAP. The epigastric region appears most suitable for AWT measurements. Further longitudinal clinical studies are needed to assess usefulness of AWT measurements for monitoring of IAP.

WSES guidelines for emergency repair of complicated abdominal wall hernias

Emergency repair of complicated abdominal hernias is associated with poor prognosis and a high rate of post-operative complications.A World Society of Emergency Surgery (WSES) Consensus Conference was held in Bergamo in July 2013, during the 2nd Congress of the World Society of Emergency Surgery with the goal of defining recommendations for emergency repair of abdominal wall hernias in adults. This document represents the executive summary of the consensus conference approved by a WSES expert panel.

A Comparative Assessment of Surgeons' Tracking Methods for Surgical Site Infections

BACKGROUND The incidence of surgical site infections (SSI) is considered increasingly to be an indicator of quality of care. We conducted a study in which daily inspection of the surgical incision was performed by an independent, trained team to monitor the incidence of SSI using U.S. Centers for Disease Control and Prevention (CDC) definitions, as a gold-standard measure of care. In the department of surgery, two registration systems for SSI were used routinely by the surgeon: An electronic and a plenary tracking system. The results of the independent team were compared with the outcomes provided by two registration systems for SSI, so as to evaluate the reliability of these systems as a possible alternative for indicating quality of care. METHODS The study was an incidence study conducted from May 2007 to January 2009 that included 1,000 adult patients scheduled to undergo open abdominal surgery in an academic teaching hospital. Surgical incisions were inspected daily to check for SSI according to definitions of health care-associated infections established by the CDC. Follow-up after discharge was done at the outpatient clinic of the hospital by telephone or letter in combination with patient diaries and reviews of patient charts, discharge letters, electronic files, and reported complications. Univariate and multivariable analyses were done to identify putative risk factors for missing registrations. RESULTS Of the 1,000 patients in the study, 33 were not evaluated. Surgical site infections were diagnosed in 26.8% of the 967 remaining patients, of which 18.0% were superficial incisional infections, 5.4% were deep incisional infections, and 3.4% were organ/space infections. More than 60% of SSIs were unreported in either of the departments two tracking systems for such infections. For these two systems, independent major risk factors for missing registrations were (1) the lack of occurrence of an SSI, (2) transplantation surgery, and (3) admission to non-surgical departments. CONCLUSIONS Most SSIs were not tracked with the departments two systems. These systems proved poor alternatives to the gold-standard method of quantifying the incidence of Surgical Site Infection SSI and, therefore, the quality of care. Both protocolized wound assessment and on-site documentation are mandatory for realistic quantification of the incidence of SSI.

Watchful Waiting Versus Surgery of Mildly Symptomatic or Asymptomatic Inguinal Hernia in Men Aged 50 Years and Older: A Randomized Controlled Trial

Objective: To compare if watchful waiting is noninferior to elective repair in men aged 50 years and older with mildly symptomatic or asymptomatic inguinal hernia. Background: The role of watchful waiting in older male patients with mildly symptomatic or asymptomatic inguinal hernia is still not well-established. Methods: In this noninferiority trial, we randomly assigned men aged 50 years and older with mildly symptomatic or asymptomatic inguinal hernia to either elective inguinal hernia repair or watchful waiting. Primary endpoint was the mean difference in a 4-point pain/discomfort score at 24 months of follow-up. Using a 0.20-point difference as a clinically relevant margin, it was hypothesized that watchful waiting was noninferior to elective repair. Secondary endpoints included quality of life, event-free survival, and crossover rates. Results: Between January 2006 and August 2012, 528 patients were enrolled, of whom 496 met the inclusion criteria: 234 were assigned to elective repair and 262 to watchful waiting. The mean pain/discomfort score at 24 months was 0.35 [95% confidence interval (CI) 0.28–0.41)] in the elective repair group and 0.58 (95% CI 0.52–0.64) in the watchful waiting group. The difference of these means (MD) was −0.23 (95% CI −0.32 to −0.14). In the watchful waiting group, 93 patients (35·4%) eventually underwent elective surgery and 6 patients (2·3%) received emergent surgery for strangulation/incarceration. Postoperative complication rates and recurrence rates in these 99 operated individuals were comparable with individuals originally assigned to the elective repair group (8.1% vs 15.0%; P = 0.106, 7.1% vs 8.9%; P = 0.668, respectively). Conclusions: Our data could not rule out a relevant difference in favor of elective repair with regard to the primary endpoint. Nevertheless, in view of all other findings, we feel that our results justify watchful waiting as a reasonable alternative compared with surgery in men aged 50 years and older.

Wound Closure and Postoperative Hernia Prevention Strategies

Closure of the laparotomy wound is the first and most important time point for prevention of postoperative hernia. Abdominal wound dehiscence and incisional hernia are major complications, associated with high morbidity and even mortality. Various risk models have been developed for both conditions, consisting of both patient and surgery-related risk factors. Surgical risk factors that can be influenced by surgeons include type of incision, type of suture material, and type of suture technique. In order to prevent incisional hernia in the midline incision, it is advocated to suture the abdominal wall continuously in a mass closure technique. Slowly absorbable sutures should be used with a suture length to wound length ratio of at least 4:1 using small stitches (5–8 mm) with small inter suture distances (5 mm). Currently, there is not enough evidence to support the use of retention sutures or abdominal binders to prevent incisional hernia. In high-risk patients, e.g., with obesity or abdominal aortic aneurysms, it should be considered to use prophylactic mesh (in onlay or sublay position). Prophylactic mesh in onlay position has been associated with increased incidence of seroma formation.