Preoperative high dose of dexamethasone in emergency laparotomy: randomized clinical trial.

BACKGROUND: Patients undergoing emergency laparotomy present with a profound inflammatory response, which could be an independent pathophysiological component in prolonged recovery. The aim of this study was to investigate the effects of a single preoperative high dose of intravenous dexamethasone on the inflammatory response and recovery after emergency laparotomy. METHODS: In this double-blinded placebo-controlled trial, patients were prospectively stratified according to surgical pathology (intestinal obstruction and perforated viscus) and randomized to preoperative 1 mg/kg dexamethasone or placebo at a ratio of 1 : 1. The primary outcome was C-reactive protein on postoperative day 1. Secondary outcomes were postoperative recovery, morbidity, and mortality. RESULTS: A total of 120 patients were included in the trial. On postoperative day 1, the C-reactive protein response was significantly lower in the dexamethasone group (a median of 170 versus 220 mg/l for dexamethasone and for placebo respectively; P = 0.015; mean difference = 49 (95% c.i. 13 to 85) mg/l) and when stratified according to intestinal obstruction (a median of 60 versus 160 mg/l for dexamethasone and for placebo respectively; P = 0.002) and perforated viscus (a median of 230 versus 285 mg/l for dexamethasone and for placebo respectively; P = 0.035). Dexamethasone administration was associated with improved recovery (better haemodynamics, better pulmonary function, less fatigue, and earlier mobilization). Furthermore, the dexamethasone group had a lower 90-day mortality rate (7% versus 23% for dexamethasone and for placebo respectively; relative risk 0.33 (95% c.i. 0.11 to 0.93); P = 0.023) and a decreased incidence of postoperative major complications (27% versus 45% for dexamethasone and for placebo respectively; relative risk 0.62 (95% c.i. 0.37 to 1.00); P = 0.032). CONCLUSION: A single preoperative high dose of intravenous dexamethasone significantly reduces the inflammatory response after emergency laparotomy and is associated with enhanced recovery and improved outcome. REGISTRATION NUMBER: NCT04791566 (http://www.clinicaltrials.gov).

Early intensive mobilization after acute high-risk abdominal surgery: a nonrandomized prospective feasibility trial.

BACKGROUND: Mobilization after emergency abdominal surgery is considered essential to facilitate rehabilitation and reduce postoperative complications. The aim of this study was to evaluate the feasibility of early intensive mobilization after acute high-risk abdominal (AHA) surgery. METHODS: We conducted a nonrandomized, prospective feasibility trial of consecutive patients after AHA surgery at a university hospital in Denmark. The participants followed a predefined, interdisciplinary protocol for early intensive mobilization during the first 7 postoperative days (PODs) of their hospital admission. We evaluated feasibility in accordance with the percentage of patients who mobilized within 24 hours after surgery, mobilized at least 4 times per day and achieved daily goals of time out of bed and walking distance. RESULTS: We included 48 patients with a mean age of 61 (standard deviation 17) years (48% female). Within 24 hours after surgery, 92% of the patients were mobilized and 82% or more were mobilized at least 4 times per day over the first 7 PODs. On PODs 1-3, 70%-89% of the participants achieved the daily goals of mobilization; participants still in hospital after POD 3 were less able to achieve the daily goals. Patient reported that the primary factors limiting their level of mobilization were fatigue, pain and dizziness. Participants not mobilized independently on POD 3 (28%) had significantly (p ≤ 0.04) fewer hours out of bed (4 v. 8 h), were less able to achieve the goals of time out of bed (45% v. 95%) and walking distance (62% v. 94%) and had longer hospital stays (14 v. 6 d) than participants mobilized independently on POD 3. CONCLUSION: The early intensive mobilization protocol seems feasible for most patients after AHA surgery. For nonindependent patients, however, alternative mobilization strategies and goals should be investigated.

Perioperative changes in fluid distribution and haemodynamics in acute high-risk abdominal surgery.

BACKGROUND: Understanding the pathophysiology of fluid distribution in acute high-risk abdominal (AHA) surgery is essential in optimizing fluid management. There is currently no data on the time course and haemodynamic implications of fluid distribution in the perioperative period and the differences between the surgical pathologies. METHODS: Seventy-three patients undergoing surgery for intestinal obstruction, perforated viscus, and anastomotic leakage within a well-defined perioperative regime, including intraoperative goal-directed therapy, were included in this prospective, observational study. From 0 to 120 h, we measured body fluid volumes and hydration status by bioimpedance spectroscopy (BIA), fluid balance (input vs. output), preload dependency defined as a > 10% increase in stroke volume after preoperative fluid challenge, and post-operatively evaluated by passive leg raise. RESULTS: We observed a progressive increase in fluid balance and extracellular volume throughout the study, irrespective of surgical diagnosis. BIA measured variables indicated post-operative overhydration in 36% of the patients, increasing to 50% on the 5th post-operative day, coinciding with a progressive increase of preload dependency, from 12% immediately post-operatively to 58% on the 5th post-operative day and irrespective of surgical diagnosis. Patients with overhydration were less haemodynamically stable than those with normo- or dehydration. CONCLUSION: Despite increased fluid balance and extracellular volumes, preload dependency increased progressively during the post-operative period. Our observations indicate a post-operative physiological incoherence between changes in the extracellular volume compartment and inadequate physiological preload control in patients undergoing AHA surgery. Considering the increasing overhydration during the observational period, our findings show that an indiscriminate correction of preload dependency with intravenous fluid bolus could lead to overhydration. Trial registration clinicaltrials.gov. (NCT03997721), Registered 23 May 2019, first participant enrolled 01 June 2019.

Triage and outcomes for a whole cohort of patients presenting for major emergency abdominal surgery including the No-LAP population: a prospective single-center observational study.

PURPOSE: This study aimed to characterize 252 consecutive patients with an indication for major emergency abdominal surgery including patients not proceeding to surgery (No-Lap). Patients who do not proceed to major emergency abdominal surgery and their clinical outcomes are not well characterized in the existing literature. Triage criteria may vary between centers, potentially impacting reported outcomes. METHODS: A single-center prospective observational study in a high-volume Danish surgical center including 252 patients presenting with an indication for major emergent abdominal surgery was conducted from the 15th of October 2020 to the 15th of August 2021. The primary outcome was to estimate the prevalence of No-Lap patients. RESULTS: Overall, 21 patients (8.3%) of our total study cohort did not proceed to surgery. These patients were significantly older, more comorbid with higher ASA scores, poorer performance status, and were more likely to have bowel ischemia. Poor functional performance and surgeons' consideration of futile intervention were the main reasons for deferring surgery in all 21 patients. Overall, 30-day mortality was 95% for the No-LAP cohort, 9% for the LAP cohort, and 16% for the whole cohort, respectively. CONCLUSIONS: The No-LAP group selection process could be one of the main determinants of reported postoperative outcomes. Prospective international multi-center studies to characterize the entire cohort of patients eligible for emergency laparotomy including the No-LAP population are needed, as large variations in triage criteria and culture seem to exist. Trial registration Retrospectively registered.

EUS-guided drainage of large walled-off pancreatic necroses using plastic versus lumen-apposing metal stents: a single-centre randomised controlled trial.

OBJECTIVE: In treating pancreatic walled-off necrosis (WON), lumen-apposing metal stents (LAMS) have not proven superior to the traditional double pigtail technique (DPT). Among patients with large WON (>15 cm) and their associated substantial risk of treatment failure, the increased drainage capacity of a novel 20-mm LAMS might improve clinical outcomes. Hence, we conducted a study comparing the DPT and 20-mm LAMS in patients with large WON. DESIGN: A single-centre, open-label, randomised, controlled superiority trial using an endoscopic step-up approach in patients with WON exceeding 15 cm in size. The primary endpoint was the number of necrosectomies needed to achieve clinical success (clinical and CT resolution), while the secondary endpoints included technical success, adverse events, length of stay and mortality. RESULTS: Twenty-two patients were included in the DPT group and 20 in the LAMS group, with no significant differences in patient characteristics. The median size of WON was 24.1 cm (P25-P75: 19.6-31.1). The technical success rates were 100% for DPT and 95% for LAMS (p=0.48), while clinical success rates were 95.5% and 94.7%, respectively (p=1.0). The mean number of necrosectomies was 2.2 for DPT and 3.2 for LAMS (p=0.42). Five patients (12%) developed procedure-related serious adverse events (DPT=4, LAMS=1, p=0.35). The median length of stay was 43 (P25-P75: 40-67) and 58 days (P25-P75: 40-86) in the DPT and LAMS groups (p=0.71), respectively, with an overall mortality of 4.8%. CONCLUSIONS: For treating large WON, LAMS are not superior to DPT. The techniques are associated with comparable needs for necrosectomy and hospital stay, and no gross difference in adverse events. TRIAL REGISTRATION NUMBER: NCT04057846.

[Endoscopic transduodenal removal of gallbladder stones in a patient with necrotizing pancreatitis].

This case report describes a 55-year-old man with gallstone-induced necrotizing pancreatitis, colonic fistula and subsequent acute cholecystitis. Due to hostile abdominal milieu, traditional cholecystectomy was not possible, why endoscopic ultrasound (EUS)-guided transduodenal drainage of the gallbladder and endoscopic stone extraction was performed successfully. EUS-guided transduodenal drainage of the gallbladder with endoscopic removal of stones constitutes a safe alternative for patients who have cholecystitis, which is not suitable for cholecystectomy.

Electrolyte and Acid-Base Disturbances in Emergency High-Risk Abdominal Surgery, a Retrospective Study.

BACKGROUND: Patients undergoing emergency high-risk abdominal surgery potentially suffer from both systemic dehydration and hypovolaemia. Data on the prevalence and clinical impact of electrolyte disturbances in this patient group, specifically the differences in patients with intestinal obstruction (IO) versus perforated viscus (PV) are lacking. METHODS: Adult patients undergoing emergency high-risk abdominal surgery in a standardized perioperative pathway were included in this retrospective single-center cohort study. Electrolytes and arterial blood gas analysis were measured during the early perioperative period. Prevalence and clinical impact of electrolyte disturbances were assessed. RESULTS: A total of 354 patients were included in the study. Preoperative alkalemia dominated preoperatively, significantly more prevalent in IO (45 vs. 32%, p < .001), while acidosis was most pronounced postoperatively in PV (49 vs. 28%, p < .0001). Preoperative hypochloraemia and hypokalemia were more frequent in the IO (34 vs. 20% and 37 vs. 25%, respectively). Hyponatremia was highly prevalent in both IO and PV. Pre- and postoperative hypochloremia were independently associated with 30-day postoperative morbidity and mortality in patients with IO (OR 2.87 (1.35, 6.23) p = 0.006, OR 6.86 (1.71, 32.2) p = 0.009, respectively). Hypochloremic patients presented with reduced long-term survival as compared with the normo- and hyperchloremic patients (p < 0.05). Neither plasma sodium nor potassium showed a significant association with outcome. CONCLUSION: These observations suggest that acute high-risk abdominal patients have frequent preoperative alkalosis shifting to postoperative acidosis. Both pre- and postoperative hypochloremia were independently associated with both impaired short- and long-term outcome in patients with intestinal obstruction, with potential implications for the choice of resuscitations fluids.

Simultaneous endoscopic and video-assisted retroperitoneal debridement in walled-off pancreatic necrosis using a laparoscopic access platform: Two case reports.

BACKGROUND: Infected walled-off necrosis is a potentially life-threatening complication of necrotizing pancreatitis. While some patients can be treated by drainage alone, many patients also need evacuation of the infected debris. Central necroses in relation to the pancreatic bed are easily reached via an endoscopic transluminal approach, whereas necroses that involve the paracolic gutters and the pelvis are most efficiently treated via a percutaneous approach. Large and complex necroses may need a combination of the two methods. CASE SUMMARY: Transluminal and percutaneous drainage followed by simultaneous endoscopic and modified video-assisted retroperitoneal debridement was carried out in two patients with very large (32-38 cm), infected walled-off necroses using a laparoscopic access platform. After 34 d and 86 d and a total of 9 and 14 procedures, respectively, complete regression of the walled-off necroses was achieved. The laparoscopic access platform improved both access to the cavities as well as the overview. Simultaneous transluminal and percutaneous necrosectomy are feasible with the laparoscopic access platform serving as a useful adjunctive. CONCLUSION: This approach may be necessary to control infection and achieve regression in some patients with complex collections.

Clinical outcomes following endoscopic or video-assisted retroperitoneal management of acute pancreatitis with large (>15 cm) walled-off pancreatic necrosis: Retrospective, single tertiary center cohort study.

OBJECTIVE: Acute pancreatitis with walled-off necrosis (WON) is associated with considerable morbidity and mortality. Previous studies have evaluated outcomes in WON collections of limited size, while data about large WON with long-term follow-up are lacking. We aimed to report our experience in managing large WON. METHODS: Between 2010 and 2020, consecutive patients with large (>15 cm) WON were identified from a prospectively maintained database. Patients with chronic pancreatitis or an index intervention 90 days or more from the debut of symptoms were excluded. We registered clinical and technical outcomes following minimally invasive treatment in WON >15 cm. Follow-up was a minimum of 1 year. RESULTS: Overall, 144 patients with WON >15 cm, with a median age of 60 (interquartile range [IQR] 49-69) years, were included. The median WON size was 19.2 cm (IQR 16.8-22.1). Most patients were treated with endoscopic transluminal drainage (93%). The median length of stay was 53 days (IQR 39-76) and 61 (42%) patients needed intensive care support during their hospital stay. As 143 patients (99%) were managed using endoscopic or video-assisted retroperitoneal techniques, only one (0.7%) patient needed an open necrosectomy. Procedure-related adverse events occurred in 10 (7%) patients. Overall, 24 patients (17%) died during admission, all due to multiorgan failure. The median follow-up was 35 months (IQR 15-63.5). Complete resolution was achieved in all remaining patients. CONCLUSION: Minimally invasive treatment of large WON is feasible, with a minimal need for surgery and acceptable rates of morbidity and mortality.

AHA STEROID trial, dexamethasone in acute high-risk abdominal surgery, the protocol for a randomized controlled trial.

INTRODUCTION: Existing multimodal pathways for patients undergoing acute high-risk abdominal surgery for intestinal obstruction (IO) and perforated viscus (PV) have focused on rescue in the immediate perioperative period. However, there is little focus on the peri-operative pathophysiology of recovery in this patient group, as done to develop enhanced recovery pathways in elective care. Acute inflammation is the main driver of the perioperative pathophysiology leading to adverse outcomes. Pre-operative high-dose of glucocorticoids provides a reduction in the inflammatory response after surgery, effective pain relief in several major surgical procedures, as well as reduce fatigue and improving endothelial dysfunction. AIM: To evaluate the effect of high-dose glucocorticoid on the inflammatory response, fluid distribution and recovery after acute high-risk abdominal surgery in patients with IO and PV. METHODS: AHA STEROID trial is a sponsor-initiated single-center, randomized, double-blind placebo-controlled trial, assessing preoperative high-dose dexamethasone (1 mg/kg) versus placebo (normal saline) in patients undergoing emergency high-risk abdominal surgery. We plan to enroll 120 patients. Primary outcome is the reduction in C-reactive protein on postoperative day 1 as a marker of successful attenuation of the acute stress response. Secondary outcomes include perioperative changes in endothelial and other inflammatory markers, fluid distribution, pulmonary function, pain, fatigue, and mobilization. The statistical plan is outlined in the protocol. DISCUSSION: The AHA STEROID trial will provide important evidence to guide the potential use of high-dose glucocorticoids in emergency high-risk abdominal surgery, with respect to different pathophysiologies.

[Videoscopic-assisted retroperitoneal debridement ofnecrotising pancreatitis].

Acute necrotising pancreatitis is a condition associated with high morbidity and mortality, and for decades surgical intervention was the gold standard for treatment of symptomatic pancreatic necrosis. A shift towards minimally invasive interventions has reduced the mortality significantly as summarised in this review. Studies comparing open necrosectomy with videoscopic-assisted retroperitoneal debridement (VARD) have demonstrated that VARD lowers morbidity and mortality. When endoscopic therapy is impossible, VARD is recommended as the preferred surgical intervention for symptomatic necrotising pancreatitis.

Inflammatory response, fluid balance and outcome in emergency high-risk abdominal surgery.

BACKGROUND: The main disease etiologies requiring emergency high-risk abdominal surgery are intestinal obstruction and perforated viscus and the differences in immune response to these pathologies are largely unexplored. In search of improvement of patient assessment in the perioperative phase, we examined the inflammatory response in this setting, focusing on potential difference in pathophysiology. METHODS: The electronic medical records of 487 patients who underwent emergency abdominal surgery from year 2013-2015 for intestinal obstruction and perforated viscus were reviewed. We evaluated the relationship between pre- and postoperative C-reactive protein (CRP) trajectory, fluid balance, and perioperative morbidity and mortality according to type of surgery, intervention, and surgical pathology. RESULTS: A total of 418 patients were included. Pre- and postoperative absolute CRP values were significantly higher in patients with perforated viscus (n = 203) than in intestinal obstruction (n = 215) (P < .0001). Relative changes at hour 6 and POD 1 were non-significant (P = .716 and P = .816 respectively). There was significant association between both pre- (quartile 1 vs 4, OR 5.11; P < .01) and postoperative (quartile 1 vs 4, OR 4.10; P < .001) CRP and adverse outcome, along with fluid balance and adverse outcome in patients with obstruction but not in those with perforation. Fluid balance and CRP had statistically significant positive correlation in patients with obstruction. CONCLUSIONS: In this explorative study, a high pre- and postoperative CRP and a high positive fluid balance were associated with worse outcome in patients with intestinal obstruction, but not in patients with perforated viscus. Future studies should address the different inflammatory and fluid trajectories in these specific pathologies.

[Abdominal cocoon syndrome in an eigth-year-old girl caused acute bowel obstruction].

This case report describes an eight-year-old girl who was admitted under the suspicion of gastroenteritis. The physical examination revealed symptoms of acute bowel obstruction, which was confirmed by abdominal CT scan. Explorative laparotomy showed a fibrotic membrane encapsulating the small intestine causing obstruction and ischaemia, and the perioperative diagnosis was abdominal cocoon syndrome. Two metres of the small intestine, excessive peritoneal membrane and the appendix was resected and an ileostomy was performed. The patient recovered with antibiotics, fluid therapy and parenteral nutrition.

The impact of acute high-risk abdominal surgery on quality of life in elderly patients.

INTRODUCTION: Undergoing acute high-risk abdominal (AHA) surgery is associated with reduced survival and a great risk of an adverse outcome, especially in the elderly. The primary aim of this study was to investigate the residential status and quality of life in elderly patients undergoing AHA surgery. METHODS: From 1 November 2014 to 30 April 2015, consecutive patients (≥ 75 years) undergoing AHA surgery were included for follow-up after six months. The patients included answered a health-related quality-of-life questionnaire and a supplemental questionnaire regarding residential status. The results were compared with an age-matched national control group. RESULTS: A total of 52 patients matched the inclusion crit-eria. Mortality at six months after surgery was 46%. Out of the 28 survivors, 22 participated in the study. Quality of life was estimated as good in 77% of the survivors and they were willing to undergo surgery again, if necessary. All study participants were admitted from their own home, and 95% had no change in residential status after six months. CONCLUSIONS: The self-reported quality of life in elderly survivors six months after AHA surgery was surprisingly good in a small study where all findings should be interpreted with precaution. The majority had no change in residential status. Our study may provide useful information for surgeons advising elderly patients and their families about realistic outcomes following AHA surgery. FUNDING: none. TRIAL REGISTRATION: The study was approved by the Danish Data Protection Agency and registered with clinicaltrials.gov.

Increased mortality in the elderly after emergency abdominal surgery.

INTRODUCTION: The purpose of this study was to evaluate the relation between preoperative delay and mortality in surgical patients undergoing primary emergency laparotomy (PEL) in an unselected, well-described patient cohort in a university hospital setting. MATERIAL AND METHODS: This study was a retrospective analysis of patient charts and perioperative documentation in an unselected consecutive cohort of 131 patients. Covariates for survival outcomes were evaluated in a multivariate analysis. No external funding and no competing interests were declared. The study was approved by The Danish Data Protection Agency; and in pursuance of national Danish research guidelines concerning retrospective studies, approval from ethics committee was not relevant. RESULTS: PEL was performed in 131 patients in the observation period. The median age of the patients was 68 years. The median time from admission to start of operation for all patients was 9.5 hours. No association between a time to operation exceeding six hours and post-operative mortality was found (adjusted odds ratio (95% confidence interval) = 0.67 (0.25-1.78)). Patients over 75 years of age had a very high mortality (47.8%). Most patients died within 30 days post-operatively. CONCLUSION: Acute admission and emergency laparotomy is associated with a very high mortality, especially in elderly patients. However, delay in the surgical treatment exceeding six hours is not associated with a higher mortality. There may be a considerable potential for improving care and management in these patients through a more systematic approach.

Severe upper gastrointestinal bleeding in extraluminal diverticula in the third part of the duodenum.

The successful management of upper gastrointestinal (GI) bleeding requires identification of the source of bleeding and when this is achieved the bleeding can often be treated endoscopically. However, the identification of the bleeding can be challenging due to the location of the bleeding or technical aspects. Therefore it might be necessary to use other measures than endoscopy such as CT angiography. Duodenal diverticula is a rare cause of upper GI bleeding and can be challenging to diagnose as they often require specialised endoscopy procedures such as endoscopy with a side-viewing scope. This case describes the first successful management of this rare condition with an upper GI endoscopy with a colonoscope and afterwards intravascular coiling.

Asymptomatic body packers should be treated conservatively.

INTRODUCTION: Body packing takes advantage of the human storage capacity within the alimentary tract. Body packing is used for the smuggling of drugs such as heroin, cocaine, amphetamine, hashish and ecstasy. Most body packers are asymptomatic. However, packets may rupture or obstruct the alimentary tract. Preventive surgery has been recommended for body packers with package retention beyond 5-7 days to prevent the serious consequences of leakage and rupture. The purpose of the present study was to evaluate a conservative protocolled approach to body packers. MATERIAL AND METHODS: We retrospectively registered all patients suspected of body packing who were brought to a department of surgical gastroenterology. The study comprised a two-year study period from 1 March 2011 to 28 February 2013. RESULTS: A total of 57 patients suspected of body packing were detained and admitted to a hospital. In 29 (53%) of the patients, body packing was confirmed by CT. All 29 body packers were successfully treated conservatively without surgical or endoscopical intervention. The median number of packages ingested was 55 (range 2-120). The body packers were all foreigners and originated from either Eastern Europe or West Africa. In one patient, body packages were retained for 17 days. None of the body packers underwent emergency operation or had signs of rupture. CONCLUSION: Body packers can be treated conservatively unless there is clinical suspicion of acute obstruction, perforation or intoxication. Package retention per se is not an indication for emergency operation. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.

[Perforated duodenal ulcer in a Roux-en-Y gastric bypass operated patient can be a diagnostic challenge]. / Perforeret duodenalt ulcus efter Roux-en-Y gastrisk bypass kan være en diagnostisk udfordring.

Roux-en-Y gastric bypass (RYGBP) is an increasingly used procedure when treating morbid obesity. Due to the extensive gastrointestinal rearrangement, diagnostic evaluation of patients with gastric bypass and acute abdominal pain can be difficult. We present a case of a perforated duodenal ulcer in a RYGBP operated patient, where free abdominal fluid, but hardly any pneumoperitoneum was seen on a computed tomography. Free intraperitoneal fluid is an important finding and should give suspicion of the need for emergency surgery in RYGBP operated patients with abdominal pain.

Relatively high incidence of complications after loop ileostomy reversal.

INTRODUCTION: A de-functioning loop ileostomy (LI) reduces the consequences of anastomotic leak following low anterior resection, but its construction as well as its closure can be associated with complications. The aim of the present study was to identify risk factors for postoperative complications and particularly to determine if operation performed by trainees carry a higher risk of complications than operation performed by experienced surgeons. MATERIAL AND METHODS: This was a retrospective single-centre analysis of the medical records of 159 consecutive patients who underwent LI closure following low anterior resection for rectal cancer in the period from January 2002 to December 2008. RESULTS: Postoperative complications developed in 32 patients (20.1%). Surgical complications occurred in 27 patients (17%) including small bowel obstruction in five (3%), anastomotic leak in four (2.5%), wound infection in eight (5%) and incisional hernia in eight (5%). There was no postoperative mortality. Univariate analysis showed that an increased rate of complications was associated with female gender (p = 0.02), small bowel resection at closure (p = 0.009) and a long interval between construction and closure of the loop ileostomy (p = 0.049). CONCLUSION: Closure of an LI is associated with a low mortality, but a relatively high rate of complications. Operation performed by trainees was not associated with an increased complication rate. More complications were seen in patients who underwent small bowel resection and those who had delayed ileostomy closure. FUNDING: not relevant TRIAL REGISTRATION: not relevant.