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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. 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. 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. 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. Erasmus University Medical Center and Ethicon.

PurposeThe short-stitch technique for midline laparotomy closure has been shown to reduce hernia rates, but long stitches remain the standard of care and the effect of the short-stitch technique on short-term results is not well known. The aim of this study was to compare the two techniques, using an ultra-long-term absorbable elastic suture material. MethodsFollowing elective midline laparotomy, 425 patients in 9 centres were randomised to receive wound closure using the short-stitch (USP 2-0 single thread, n = 215) or long-stitch (USP 1 double loop, n = 210) technique with a poly-4-hydroxybutyrate-based suture material (Monomax®). Here, we report short-term surgical outcomes. ResultsAt 30 (+10) days postoperatively, 3 (1.40%) of 215 patients in the short-stitch group and 10 (4.76%) of 210 patients in the long-stitch group had developed burst abdomen [OR 0.2830 (0.0768–1.0433), p = 0.0513]. Ruptured suture, seroma and hematoma and other wound healing disorders occurred in small numbers without differences between groups. In a planned Cox proportional hazard model for burst abdomen, the short-stitch group had a significantly lower risk [HR 0.1783 (0.0379–0.6617), p = 0.0115]. ConclusionsAlthough this trial revealed no significant difference in short-term results between the short-stitch and long-stitch techniques for closure of midline laparotomy, a trend towards a lower rate of burst abdomen in the short-stitch group suggests a possible advantage of the short-stitch technique.Trial registryNCT01965249, registered October 18, 2013.

The standard surgery for early-stage endometrial cancer is total abdominal hysterectomy (TAH) and bilateral salpingo-oophorectomy, which is associated with substantial morbidity. Total laparoscopic hysterectomy (TLH) and bilateral salpingo-oophorectomy is less invasive and is assumed to be associated with lower morbidity, particularly in obese women. This study investigated the complication rate of TLH versus TAH in women with early-stage endometrial cancer. This randomised trial was done in 21 hospitals in the Netherlands, and 26 gynaecologists with proven sufficient skills in TLH participated. 283 patients with stage I endometrioid adenocarcinoma or complex atypical hyperplasia were randomly allocated (2:1) to the intervention group (TLH, n=187) or control group (TAH, n=96). Randomisation by sequential number generation was done centrally in alternate blocks of six and three participants, with stratification by trial centre. After assignment, the study coordinators, patients, gynaecologists, and members of the panel were not masked to intervention. The primary outcome was major complication rate, assessed by an independent panel. Data were analysed by a modified intention-to-treat analysis, since two patients in both groups were excluded from the main analysis. This trial is registered with the Dutch trial registry, number NTR821. The proportion of major complications was 14·6% (27 of 185) in the TLH group versus 14·9% (14 of 94) in the TAH group, with a difference of −0·3% (95% CI −9·1 to 8·5; p=0·95). The proportion of patients with an intraoperative major complication (nine of 279 [3·2%]) was lower than the proportion with a postoperative major complication (32 of 279 [11·5%]) and did not differ between TLH (five of 185 [2·7%]) and TAH (four of 94 [4·3%]; p=0·49). The proportion of patients with a minor complication was 13·0% (24 of 185) in the TLH group and 11·7% (11 of 94) in the TAH group (p=0·76). Conversion to laparotomy occurred in 10·8% (20 of 185) of the laparoscopic procedures. TLH was associated with significantly less blood loss (p<0·0001), less use of pain medication (p<0·0001), a shorter hospital stay (p<0·0001), and a faster recovery (p=0·002), but the procedure took longer than TAH (p<0·0001). Our results showed no evidence of a benefit for TLH over TAH in terms of major complications, but TLH (done by skilled surgeons) was beneficial in terms of a shorter hospital stay, less pain, and quicker resumption of daily activities. The Dutch Organization for Health Research and Development (ZonMw), programme efficacy.

This two-stage randomised controlled trial, comparing total laparoscopic hysterectomy (TLH) with total abdominal hysterectomy (TAH) for stage I endometrial cancer (LACE), began in 2005. The primary objective of stage 1 was to assess whether TLH results in equivalent or improved quality of life (QoL) up to 6 months after surgery compared with TAH. The primary objective of stage 2 was to test the hypothesis that disease-free survival at 4·5 years is equivalent for TLH and TAH. Here, we present the results of stage 1. Between Oct 7, 2005, and April 16, 2008, 361 participants were enrolled in the QoL substudy at 19 centres across Australia, New Zealand, and Hong Kong; 332 completed the QoL analysis. Randomisation was done centrally and independently from other study procedures via a computer-generated, web-based system (providing concealment of the next assigned treatment), using stratified permuted blocks of three and six patients. Patients with histologically confirmed stage I endometrioid adenocarcinoma and Eastern Cooperative Oncology Group performance status less than 2 were randomly assigned to TLH (n=190) or TAH (n=142), stratified by histological grade and study centre. Patients and study personnel were not masked to treatment assignment. QoL was measured at baseline, 1 and 4 weeks (early), and 3 and 6 months (late) after surgery, using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. The primary endpoint was the difference between groups in QoL change from baseline at early and late timepoints (a 5% difference was considered clinically significant). Analysis was done according to the intention-to-treat principle. Patients for both stages of the trial have now been recruited and are being followed up for disease-specific outcomes. The LACE trial is registered with ClinicalTrials.gov, number NCT00096408. Eight of 332 patients (2·4%) had treatment conversion—seven from TLH to TAH and one from TAH to TLH (patient preference). In the early phase of recovery, patients who had TLH reported significantly greater improvement in QoL from baseline compared with those who had TAH, in all subscales apart from emotional and social wellbeing. Improvements in QoL up to 6 months after surgery continued to favour TLH, except in the emotional and social wellbeing measures of FACT and the visual analogue scale of the EuroQoL five dimensions (EuroQoL-VAS). Operating time was significantly longer in the TLH group (138 min [SD 43]) than in the TAH group (109 min [34]; p=0·001). Although the proportion of intraoperative adverse events was similar between groups (TAH eight of 142 [5·6%] vs TLH 14 of 190 [7·4%]; p=0·53); postoperatively, twice as many patients in the TAH group experienced adverse events of grade 3 or higher (33 of 142 [23·2%] vs 22 of 190 [11·6%] in the TLH group; p=0·004). Postoperative serious adverse events occurred more in the TAH group (27 of 142 [19·0%]) than in the TLH group (16 of 190 [7·9%]; p=0·002). QoL improvements from baseline during early and later phases of recovery, and the adverse event profile, favour TLH compared with TAH for treatment of stage I endometrial cancer. Cancer Council Queensland, Cancer Council New South Wales, Cancer Council Victoria, Cancer Council Western Australia; NHMRC project grant 456110; Cancer Australia project grant 631523; The Women and Infants Research Foundation, Western Australia; Royal Brisbane and Women's Hospital Foundation; Wesley Research Institute; Gallipoli Research Foundation; Gynetech; TYCO Healthcare, Australia; Johnson and Johnson Medical, Australia; Hunter New England Centre for Gynaecological Cancer; Genesis Oncology Trust; and Smart Health Research Grant QLD Health.

PurposeIncisional hernia (IH) has an incidence of 10–23%, which can increase to 38% in specific risk groups. The objective of this study is to report the results at 3 years of follow-up of the use of the reinforced tension line (RTL) technique compared with primary suture only (PSO) closure in the prevention of IH in high-risk patients undergoing laparotomy. MethodsOpen randomized controlled clinical trial. Included were patients older than 18 years who underwent midline laparotomy, emergency or scheduled, who were considered high risk, and who completed 3-year follow-up. The patients were randomized 1:1 to the RTL technique or to PSO. The objective was to report the incidence of IH and the complications associated with the closure method. Intention-to-treat analysis and Cox regression were performed. ResultsA total of 124 patients were randomized; 51 patients from the RTL group and 53 patients from the PSO group finished the 3-year follow-up. The incidence of IH was higher in the PSO group (15/53, 28.3%) than the RTL group (5/51, 9.8%) (p = 0.016, OR 0.35, 95% CI 0.14–0.88, number needed to treat 5.4, log-rank test p = 0.017). The groups were similar in the rates of surgical site infection, hematoma, seroma, and postoperative pain during follow-up.ConclusionsThe RTL technique is useful in the prevention of IH when compared with PSO in high-risk midline laparotomy patients, and it is not associated with a higher percentage of complications.Trial registrationLocal Committee CI-HRAEB-2013-020. March 13, 2013.Clinical trialsNCT02136628, retrospectively registered.

Background Enhanced Recovery After Surgery (ERAS) is a multimodal approach with promising results in improving patient outcome. Only recently, is evidence emerging highlighting how similar principles of care can be applied to patients undergoing emergency abdominal surgery. Methods A randomized controlled trial was conducted from November 2021 to April 2022 at PGIMER Chandigarh, which is a leading tertiary care hospital in northern India. 60 patients with acute intestinal obstruction requiring emergency laparotomy were randomized and assigned to ERAS or Non-ERAS group. ERAS protocol with some modifications was applied. Primary endpoints were post-operative hospital stay. Secondary end points were morbidity, 30-day readmission and mortality rate. Data analysis was done using SPSS 22.0. Independent t test or Mann–Whitney test and Chi-square or Fisher-exact test were used for analysis. Results A significant 3-day reduction in hospital stay was observed in ERAS compared to non-ERAS group (median (interquartile range) 5.50 (4.75–8.25) vs 8.0 (6.0–11.0) p  = 0.003) with no difference in 30-day readmission rate, mortality rate and complication rate (according to Clavien–Dindo classification). ERAS group was associated with early recovery of gastrointestinal functions including time to first passage of flatus ( p  < 0.001), stools ( p  = 0.014), early ambulation ( p  < 0.001), time to first fluid diet ( p  < 0.001), solid diet ( p  = 0.001) and reduced nasogastric tube reinsertion rates ( p  = 0.01) despite its early removal. Conclusion ERAS with some modifications can be applied in patients with intestinal obstruction. Thus, we can expedite post-operative recovery and early regain of gastrointestinal function with decreased hospital stay, comparable morbidity and mortality. Further studies are needed to assess ERAS role in emergency gastrointestinal surgeries. Trial registration Ctri.gov Identifier: CTRI/2022/04/042156.

PurposeTo compare reinforced tension line (RTL) and mesh techniques in the onlay position for preventing abdominal wound dehiscence (AWD) in a noninferiority clinical trial.MethodsPatients > 18 years old who underwent midline laparotomy and who were considered at high risk on the modified Rotterdam risk scale were included. The outcomes analyzed were the incidence of AWD and surgical site occurrence (SSO).Results239 patients were included: 121 mesh group and 118 RTL group. Five (4.1%) of the 121 patients in the mesh group and 7 (5.9%) of the 118 patients in the RTL group presented with AWD (p = 0.56, RR = 0.69, 95% CI = 0.22–2.13) in the per-protocol analysis. The median time of presentation was 6 days. The 95% CI (−0.0567, 0.0231) for the difference in incidence between the two groups was entirely within the predefined noninferiority margin of 5%. The incidence of complications did not significantly differ between the two groups: the mesh group (27, 22.3%) and the RTL group (16, 12.8%) (p = 0.09, RR (95% CI) = 1.64 (0.93–2.89)).ConclusionThe use of the RTL technique for preventing AWD was not inferior to the use of mesh in the onlay position, nor did it increase the risk of complications. This study was registered on clinicaltrials.gov: Mesh-RTL Project (NCT04134455).

Enhanced recovery after surgery(ERAS) is a set of multiple perioperative care component not a rigid protocol with improved outcomes for elective surgeries. This study aimed to assess the feasibility and outcomes in trauma patients undergoing laparotomy. Prospective single-centre randomized controlled trial(RCT). Patients undergoing emergency laparotomy following trauma were randomized into ERAS(early removal of catheters, early mobilization and initiation of diet, use of opioid-sparing multimodal analgesia) and conventional care groups 24 ​h post-surgery. Outcome measures included length of hospitalization(LOH), recovery of bowel function, duration of removal of catheters and 30-day complications(Clavien-Dindo). Fifty patients were randomized into ERAS(n ​= ​25) and conventional care(n ​= ​25) groups. Ninety-two percent of patients were young males, 58 ​% had blunt trauma to the abdomen and the most common indication of surgery was hollow viscus injury(88 ​%). ERAS group had a reduced median LOH(days) (6 versus 8, p ​= ​0.007), early recovery of bowel function(p ​= ​0.010) and shorter times for nasogastric tube(p ​= ​0.001), urinary catheter(p ​= ​0.007) and drain(p ​= ​0.006) removal. The complications were comparable in both groups except for deep surgical site infection[significantly lower in ERAS group(p ​= ​0.009)]. ERAS is safe and significantly reduces LOH in select trauma patients undergoing laparotomy. •The major aim of perioperative care-attenuate the surgical stress response.•ERAS is a method, not a rigid protocol.•Leads to reduced length of hospital stay without increased complication rates.•Widely accepted in the elective setup-paucity of studies in trauma patients.

BackgroundThe use of mesh is the standard for the prevention of incisional hernia (IH). However, the effect of surgical site occurrence (SSO) has never been compared. The aim of this meta-analysis was to evaluate the prevalence of SSO and measure its negative effect through the calculation of the number needed to treat for net effect (NNT net).MethodsA meta-analysis was performed according to the PRISMA guidelines. The primary objective was to determine the prevalence of SSO and IH, and the secondary objective was to determine the NNT net as a metric to measure the combined benefits and harms. Only published clinical trials were included. The risk of bias was analyzed, and the random effects model was used to determine statistical significance.ResultsA total of 15 studies comparing 2344 patients were included. The incidence of IH was significantly lower in the mesh group than in the control group, with an OR of 0.29 (95% CI 0.16–0.49, p = 0.0001). The incidence of SSO was higher in the mesh group than in the control group, with an OR of 1.21 (95% CI 0.85–1.72, p = 0.0001) but without statistical significance. Therefore, the way to compare the benefits and risks of each of the studies was done with the calculation of the NNT net, which is the average number of patients who need to be treated to see the benefit exceeding the harm by one event, and the result was 5, which is the average number of patients who need to be treated to see the benefit exceeding the harm by one event.ConclusionThe use of mesh reduces the prevalence of IH and it does not increases the prevalence of SSO, the NNT net determined that the use of mesh continues to be beneficial for the patient.

Purpose The objective of this study is to assess the effectiveness and safety of onlay mesh closure of emergency midline laparotomy to prevent incisional hernia. Methods This is a prospective randomized double-blind study and was carried out in the General Surgery Clinic, Konya City Hospital, from August 1, 2020 to August, 1, 2021. The study included 108 patients who were randomly grouped in 2 groups: patients with conventional abdominal closure and closure using additional onlay mesh (1:1). The follow-up period was for a year. The primary outcome was the incidence of incisional hernia and secondary outcomes were clinical data like complications, hospital length of stay, re-operations. Results It was observed that incisional hernia was present in 14 patients (27.4%) in conventional abdominal closure group and was in 2 patients using mesh (4%), ( p  = 0.001). Clavien–Dindo 3B complications were in rise in conventional closure group ( p  = 0.02). Of all complications, burst abdomen was significantly more common in conventional closure group ( p  = 0.04). The rate of surgically treated complications were higher in conventional closure group ( p  = 0.02). Clavien–Dindo 3A complications were more common in patients with contaminated wound in mesh group ( p  = 0.02). Conclusion The use of mesh while closing the abdomen in emergency midline laparotomy reduces the risk of incisional hernia. Thus, to lower the risks of incisional hernia and its complications, prophylactic mesh can be used in high-risk patients.