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1,880 result(s) for "Intestinal Perforation - surgery"
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Laparoscopic peritoneal lavage or sigmoidectomy for perforated diverticulitis with purulent peritonitis: a multicentre, parallel-group, randomised, open-label trial
Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in patients with perforated diverticulitis. We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in patients with purulent perforated diverticulitis, with respect to overall long-term morbidity and mortality. We did a multicentre, parallel-group, randomised, open-label trial in 34 teaching hospitals and eight academic hospitals in Belgium, Italy, and the Netherlands (the Ladies trial). The Ladies trial is split into two groups: the LOLA group comparing laparoscopic lavage with sigmoidectomy and the DIVA group comparing Hartmann's procedure with sigmoidectomy plus primary anastomosis. The DIVA section of this trial is still underway but here we report the results of the LOLA section. Patients with purulent perforated diverticulitis were enrolled for LOLA, excluding patients with faecal peritonitis, aged older than 85 years, with high-dose steroid use (≥20 mg daily), and haemodynamic instability. Patients were randomly assigned (2:1:1; stratified by age [<60 years vs ≥60 years]) using secure online computer randomisation to laparoscopic lavage, Hartmann's procedure, or primary anastomosis in a parallel design after diagnostic laparoscopy. Patients were analysed according to a modified intention-to-treat principle and were followed up after the index operation at least once in the outpatient setting and after sigmoidoscopy and stoma reversal, according to local protocols. The primary endpoint was a composite endpoint of major morbidity and mortality within 12 months. This trial is registered with ClinicalTrials.gov, number NCT01317485. Between July 1, 2010, and Feb 22, 2013, 90 patients were randomly assigned in the LOLA section of the Ladies trial when the study was terminated by the data and safety monitoring board because of an increased event rate in the lavage group. Two patients were excluded for protocol violations. The primary endpoint occurred in 30 (67%) of 45 patients in the lavage group and 25 (60%) of 42 patients in the sigmoidectomy group (odds ratio 1·28, 95% CI 0·54–3·03, p=0·58). By 12 months, four patients had died after lavage and six patients had died after sigmoidectomy (p=0·43). Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent perforated diverticulitis. Netherlands Organisation for Health Research and Development.
Laparoscopic peritoneal lavage versus sigmoidectomy for perforated diverticulitis with purulent peritonitis: three-year follow-up of the randomised LOLA trial
BackgroundThis study aimed to compare laparoscopic lavage and sigmoidectomy as treatment for perforated diverticulitis with purulent peritonitis during a 36 month follow-up of the LOLA trial.MethodsWithin the LOLA arm of the international, multicentre LADIES trial, patients with perforated diverticulitis with purulent peritonitis were randomised between laparoscopic lavage and sigmoidectomy. Outcomes were collected up to 36 months. The primary outcome of the present study was cumulative morbidity and mortality. Secondary outcomes included reoperations (including stoma reversals), stoma rates, and sigmoidectomy rates in the lavage group.ResultsLong-term follow-up was recorded in 77 of the 88 originally included patients, 39 were randomised to sigmoidectomy (51%) and 38 to laparoscopic lavage (49%). After 36 months, overall cumulative morbidity (sigmoidectomy 28/39 (72%) versus lavage 32/38 (84%), p = 0·272) and mortality (sigmoidectomy 7/39 (18%) versus lavage 6/38 (16%), p = 1·000) did not differ. The number of patients who underwent a reoperation was significantly lower for lavage compared to sigmoidectomy (sigmoidectomy 27/39 (69%) versus lavage 17/38 (45%), p = 0·039). After 36 months, patients alive with stoma in situ was lower in the lavage group (proportion calculated from the Kaplan–Meier life table, sigmoidectomy 17% vs lavage 11%, log-rank p = 0·0268). Eventually, 17 of 38 (45%) patients allocated to lavage underwent sigmoidectomy.ConclusionLong-term outcomes showed that laparoscopic lavage was associated with less patients who underwent reoperations and lower stoma rates in patients alive after 36 months compared to sigmoidectomy. No differences were found in terms of cumulative morbidity or mortality. Patient selection should be improved to reduce risk for short-term complications after which lavage could still be a valuable treatment option.
Prospectively Randomized Controlled Trial on Damage Control Surgery for Perforated Diverticulitis with Generalized Peritonitis
Introduction Damage control surgery (DCS) with abdominal negative pressure therapy and delayed anastomosis creation in patients with perforated diverticulitis and generalized peritonitis was established at our Institution in 2006 and has been published. The concept was adopted in other hospitals and published as a case series. This is the first prospectively controlled randomized study comparing DCS and conventional treatment (Group C) in this setting. Methods All consecutive patients from 2013 to 2018 with indication for surgery were screened and randomized to Group DCS or Group C. The primary outcome was the rate of reconstructed bowel at discharge and at 6 month. Informed consent was obtained. The trial was approved by the local ethics committee and registered at CinicalTrials.gov: NCT04034407. Results A total of 56 patients were screened; 41 patients gave informed consent to participate and ultimately 21 patients (9 female) with intraoperatively confirmed Hinchey III ( n  = 14, 67%) or IV ( n  = 7, 33%), and a median (range) age of 66 (42–92), Mannheim Peritonitis Index of 25 (12–37) and Charlson Comorbidity Index of 3 (0–10) were intraoperatively randomized and treated as Group DCS ( n  = 13) or Group C ( n  = 8). Per protocol analysis: A primary anastomosis without ileostomy (PA) was performed in 92% (11/12) patients in Group DCS at the second-look operation, one patient died before second look, and one underwent a Hartmann procedure (HP). In Group C 63% (5/8) patients received a PA and 38% (3/8) patients a HP. Two patients in Group C, but none in Group DCS experienced anastomotic leakage (AI). ICU and hospital stay was median (range) 2 (1–10) and 17.5 (12–43) in DCS and 2 (1–62) and 22 (13–65) days in group C. In Group DCS 8% (1/12) patients was discharged with a stoma versus 57% (4/7) in Group C ( p  = 0.038, n.s., α  = 0.025); one patient died before discharge. The odds ratio (95% confidence interval) for discharge with a stoma is 0.068 (0.005–0.861). Intent to treat analysis: A PA was performed in 90% (9/10) of patients randomized to DCS, one patient died before the second look, and one patient received a HP. In group C, 70% (7/10) were treated with PA and 30% (3/10) with HP. 29% (2/7) experienced AI treated with protective ileostomy. In group DCS, 9% (1/11) were discharged with a stoma versus 40% (4/10) in group C ( p  = 0.14, n.s.). The odds ratio for discharge with a stoma is 0.139 (0.012–1.608). Conclusion This is the first prospectively randomized controlled study showing that damage control surgery in perforated diverticulitis Hinchey III and IV enhances reconstruction of bowel continuity and can reduce the stoma rate at discharge.
Laparotomy versus Peritoneal Drainage for Necrotizing Enterocolitis and Perforation
In this multicenter, randomized trial comparing primary peritoneal drainage with laparotomy for the management of perforated necrotizing enterocolitis in preterm infants with birth weights less than 1500 g, there were no significant differences between groups in mortality at 90 days, dependence on total parenteral nutrition at 90 days, or length of the hospital stay in surviving infants. These data do not support an advantage of either primary peritoneal drainage or laparotomy over the alternative approach among preterm infants with perforated necrotizing enterocolitis. This trial compared primary peritoneal drainage with laparotomy for the management of perforated necrotizing enterocolitis in preterm infants. There were no significant differences between groups in mortality at 90 days, dependence on total parenteral nutrition at 90 days, or length of the hospital stay in surviving infants. Necrotizing enterocolitis is a severe inflammatory disorder of the intestine occurring in premature infants. It is a major cause of death and morbidity in neonates. 1 In contrast to the improvements during the past 30 years in the outcomes of many conditions affecting premature infants, the mortality rate of 30 to 50 percent for babies with intestinal perforation due to necrotizing enterocolitis remains essentially unchanged. 2 The standard approach to patients with perforated intestine, necrotic intestine, or both is surgical resection of the involved bowel with the creation of intestinal stomas. In a critically ill premature infant, this entails substantial risks. Primary . . .
Laparoscopic Versus Open Emergent Sigmoid Resection for Perforated Diverticulitis
Background Potential advantages of laparoscopic sigmoidectomy for perforated diverticulitis are still under consideration. This study is designed to determine if emergent laparoscopic sigmoidectomy for perforated diverticulitis is associated with outcomes comparable to the traditional open approach. Methods The American College of Surgeons-National-Surgical-Quality-Improvement-Program (ACS-NSQIP) database was queried for laparoscopic and open emergent sigmoidectomy cases for perforated diverticulitis from 2012 through 2017. Using propensity score weights, 30-day outcomes between laparoscopic and open approaches were compared in two ways: one with converted cases as a separate group and another with converted cases combined with the laparoscopic-completed group (intention-to-treat). Results A total of 3756 cases met inclusion criteria—282 laparoscopic-completed, 175 laparoscopic-converted-to-open, and 3299 open. The laparoscopic-completed approach had significantly better outcomes than open and laparoscopic-converted cases. When combining laparoscopic-completed and laparoscopic-converted cases (intention-to-treat), the laparoscopic approach still had significantly fewer complications per patient, less unplanned intubation ( p  = 0.01), and acute renal failure ( p  = 0.005) than the open group. Laparoscopic groups had longer operating times and shorter hospital length of stay than the open group. Subgroup analysis comparing laparoscopic and open Hartmann’s procedure and primary anastomosis with and without diverting stoma also showed favorable outcomes for the laparoscopic group. Conclusions Laparoscopic emergent sigmoid resection for perforated diverticulitis is associated with favorable outcomes compared to the open approach. Hartmann’s procedure is still common and conversion rate is high. Training efforts that increase adoption of minimally invasive surgery and decrease conversion rates are justified. Randomized trials comparing laparoscopic and open approaches may allow further critical assessment of these findings.
The effect of chewing gum on postoperative ileus after laparotomy for gastroduodenal perforations: a randomized controlled trial
Background Prolonged postoperative ileus is linked to a higher risk of additional complications, longer hospital stays, and higher healthcare expenses. There are few randomized controlled trials on the impact of chewing gum on the duration of ileus in patients undergoing emergency surgery, notably those with peritonitis. Compelling evidence from studies on elective procedures demonstrates that chewing gum can lessen the duration of ileus. This trial aimed to examine the effect of chewing gum on the length of the postoperative ileus which develop after laparotomy for gastroduodenal perforations. Materials and methods Multicentre randomized controlled trial. Fifty-two patients were randomly assigned to two treatment groups. Group A received routine care with chewing gum, while group B only received routine care. The primary outcome was the length of postoperative ileus, while the secondary outcomes were the length of hospital stay, in-hospital morbidity, and mortality. The continuous variables were compared using the nonparametric Wilcoxon Rank sum (Mann-Whitney U) test while the categorical outcomes were compared using the chi-squared test in SPSS version 26. The protocol was retrospectively registered with the WHO Pan African Clinical Trial Registry (Number: PACTR202206468032528 ) on the 1st of June 2022. Results Of the 52 participants included in the analysis, the majority were males (80.8%) with a mean age of 34.23 (SD = 11.52) years. There was no statistically significant difference in the baseline characteristics of the study participants between the two groups ( P  > 0.05 for all). The median duration of postoperative ileus was 21.5 h less in the chewing gum group (28.5 versus 50.0, P  = 0.002), while the length of hospital stay was 2.5 days less in the chewing gum group (5.4 versus 7.9, P  = 0.007). There was no significant difference noted in the occurrence of complications. Conclusion Chewing gum that is readily available and reasonably priced may help shorten the duration of post-operative ileus, which has the extra benefit of enabling early discharge.
2017 WSES guidelines on colon and rectal cancer emergencies: obstruction and perforation
ᅟ Obstruction and perforation due to colorectal cancer represent challenging matters in terms of diagnosis, life-saving strategies, obstruction resolution and oncologic challenge. The aims of the current paper are to update the previous WSES guidelines for the management of large bowel perforation and obstructive left colon carcinoma (OLCC) and to develop new guidelines on obstructive right colon carcinoma (ORCC). Methods The literature was extensively queried for focused publication until December 2017. Precise analysis and grading of the literature has been performed by a working group formed by a pool of experts: the statements and literature review were presented, discussed and voted at the Consensus Conference of the 4th Congress of the World Society of Emergency Surgery (WSES) held in Campinas in May 2017. Results CT scan is the best imaging technique to evaluate large bowel obstruction and perforation. For OLCC, self-expandable metallic stent (SEMS), when available, offers interesting advantages as compared to emergency surgery; however, the positioning of SEMS for surgically treatable causes carries some long-term oncologic disadvantages, which are still under analysis. In the context of emergency surgery, resection and primary anastomosis (RPA) is preferable to Hartmann’s procedure, whenever the characteristics of the patient and the surgeon are permissive. Right-sided loop colostomy is preferable in rectal cancer, when preoperative therapies are predicted. With regards to the treatment of ORCC, right colectomy represents the procedure of choice; alternatives, such as internal bypass and loop ileostomy, are of limited value. Clinical scenarios in the case of perforation might be dramatic, especially in case of free faecal peritonitis. The importance of an appropriate balance between life-saving surgical procedures and respect of oncologic caveats must be stressed. In selected cases, a damage control approach may be required. Medical treatments including appropriate fluid resuscitation, early antibiotic treatment and management of co-existing medical conditions according to international guidelines must be delivered to all patients at presentation. Conclusions The current guidelines offer an extensive overview of available evidence and a qualitative consensus regarding management of large bowel obstruction and perforation due to colorectal cancer.
Role of protective stoma after primary anastomosis for generalized peritonitis due to perforated diverticulitis—DIVERTI 2 (a prospective multicenter randomized trial): rationale and design (nct04604730)
Background Traditionally, patients with peritonitis Hinchey III and IV due to perforated diverticulitis were treated with Hartmann’s procedure. In the past decade, resection and primary anastomosis have gained popularity over Hartmann’s procedure and recent guidelines recommend Hartmann’s procedure in two situations only: critically ill patients and in selected patients with multiple comorbidity (at high risk of complications). The protective stoma (PS) is recommended after resection with primary anastomosis, however its interest has never been studied. The aim of this trial is to define the role of systematic PS after resection and primary anastomosis for peritonitis Hinchey III and IV due to perforated diverticulitis. Methods/design This DIVERTI 2 trial is a multicenter, randomized, controlled, superiority trial comparing resection and primary anastomosis with (control group) or without (experimental group) PS in patients with peritonitis Hinchey III and IV due to perforated diverticulitis. Primary endpoint is the overall 1 year morbidity according to the Clavien–Dindo classification of surgical complications. All complications occurring during hospitalization will be collected. Late complications occurring after hospitalization will be collected during follow-up. In order to obtain 80% power for a difference given by respective main probabilities of 67% and 47% in the protective stoma and no protective stoma groups respectively, with a two-sided type I error of 5%, 96 patients will have to be included in each group, hence 192 patients overall. Expecting a 5% rate of patients not assessable for the primary end point (lost to follow-up), 204 patients will be enrolled. Secondary endpoints are postoperative mortality, unplanned reinterventions, incisional surgical site infection (SSI), organ/space SSI, wound disruption, anastomotic leak, operating time, length of hospital stay, stoma at 1 year after initial surgery, quality of life, costs and quality-adjusted life years (QALYs). Discussion The DIVERTI 2 trial is a prospective, multicenter, randomized, study to define the best strategy between PS and no PS in resection and primary anastomosis for patients presenting with peritonitis due to perforated diverticulitis. Trial registration ClinicalTrial.gov: NCT04604730 date of registration October 27, 2020. https://clinicaltrials.gov/ct2/show/NCT04604730?recrs=a&cond=Diverticulitis&draw=2&rank=12 .
Effect of isotonic sodium bicarbonate infusion on perioperative acid–base status among patients undergoing emergency laparotomy for perforation peritonitis (ISABEL trial): a randomized controlled trial
Purpose Perioperative metabolic acidosis negatively affects patient outcomes. Perioperative fluid therapy has a clinically significant effect on acid–base balance. This study was conducted to evaluate the effects of isotonic sodium bicarbonate infusion (ISB) versus balanced crystalloid solution (BCS) on perioperative acid–base balance, in terms of postoperative base excess, among patients undergoing emergency laparotomy for perforation peritonitis. Methods This prospective, randomized, single-center, double-blinded study was conducted in a tertiary hospital from October 2021 to November 2022. A total of 90 patients undergoing emergency laparotomy for perforation peritonitis were randomly assigned to receive either isotonic sodium bicarbonate (ISB) or Ringer’s Lactate as a balanced crystalloid solution (BCS) for perioperative maintenance fluid therapy. The primary outcome was to compare the base excess (BE) at the end of surgery. The secondary outcomes were to compare the postoperative clinical outcomes, including the requirement of vasopressors, duration of mechanical ventilation, HDU/ICU stay, the incidence of AKI within seven days, the incidence of re-exploration, and in-hospital mortality. Additionally, pH, PaCO2, HCO3, BE, and lactates intraoperatively and up to 24 h postoperatively were also compared. Results The median base excess (BE) values at the end of surgery were significantly better in the ISB group − 4.80 [− 6.80, − 4.10] as compared to the BCS group − 7.30 [− 8.50, − 6.30]. The ISB group had a lower incidence of postoperative AKI (9% ISB versus 24% BCS) and requirement of vasopressors (18% ISB versus 44% BCS). However, there was no major difference between the incidence of re-exploration, length of ICU/HDU stay, and in-hospital mortality. Conclusion Infusing isotonic sodium bicarbonate (ISB) for intraoperative maintenance fluid therapy in patients undergoing emergency laparotomy for perforation peritonitis significantly improves perioperative acid–base balance with better postoperative clinical outcomes compared to a balanced crystalloid solution (BCS).
The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis in perforated diverticulitis (NTR2037)
Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy.The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis). In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90%) in favour of the patients with resection with primary anastomosis. Secondary endpoints for both arms are the number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs. The Ladies trial is a nationwide multicentre randomised trial on perforated diverticulitis that will provide evidence on the merits of laparoscopic lavage and drainage for purulent generalised peritonitis and on the optimal resectional strategy for both purulent and faecal generalised peritonitis. Nederlands Trial Register NTR2037.