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Laparoscopy Combined with Enhanced Recovery Pathway in Ileocecal Resection for Crohn's Disease: A Randomized Study.

ABSTRACT: Background and Aims:Laparoscopic approach is recommended as the first-choice option for simple ileocecal resections. However, there are no randomized trials that have focused on patients with Crohn's disease (CD) treated by laparoscopy and enhanced recovery pathway. The aim of the present study is to prospectively evaluate the feasibility, safety, and short-term outcomes of laparoscopy with enhanced recovery pathway for CD patients undergoing ileocecal resection. Methods:A consecutive cohort of 32 CD patients who underwent laparoscopic ileocecal resection between December 2015 and December 2016 was randomized to enhanced recovery after surgery (ERAS) group or standard care group. Primary outcome was total postoperative hospital stay. Secondary outcomes were time to first flatus and stool, pain scores, morbidity, reoperation rate, readmission rate, and in-hospital costs. Results:Compliance with the ERAS was high for all items (?90%) except the items of abdominal drains and early fluid intake. A significantly earlier return of bowel function was observed in the ERAS group. Compared with the standard care group, patients in the ERAS group had shorter postoperative hospital stay and lower in-hospital costs (5.19?±?1.28 versus 9.94?±?3.33?days, P < 0.001; 2.70?±?0.50 versus 3.73?±?0.75 ten thousand RMB, P < 0.001, respectively). Other parameters did not show any significant differences between the two groups. Conclusions:Laparoscopic approach within an ERAS perioperative care program is a safe and effective treatment combination for CD patients requiring ileocecal resection. This study is registered at ClinicalTrials.gov (NCT02777034).

SUBMITTER: Zhu Y

PROVIDER: S-EPMC6252211 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Laparoscopy Combined with Enhanced Recovery Pathway in Ileocecal Resection for Crohn's Disease: A Randomized Study.

Zhu Yibin Y Xiang Jianjian J Liu Wei W Cao Qian Q Zhou Wei W

Gastroenterology research and practice 20181111

<h4>Background and aims</h4>Laparoscopic approach is recommended as the first-choice option for simple ileocecal resections. However, there are no randomized trials that have focused on patients with Crohn's disease (CD) treated by laparoscopy and enhanced recovery pathway. The aim of the present study is to prospectively evaluate the feasibility, safety, and short-term outcomes of laparoscopy with enhanced recovery pathway for CD patients undergoing ileocecal resection.<h4>Methods</h4>A consecu ...[more]

PMID: 30534152

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Project description:BackgroundPatients with Crohn's disease suffer from a higher rate of anastomotic leakages after ileocecal resection than patients without Crohn's disease. Our hypothesis was that microscopic inflammation at the resection margins of ileocecal resections in Crohn's disease increases the rate of anastomotic leakages.Patients and methodsIn a retrospective cohort study, 130 patients with Crohn's disease that underwent ileocecal resection between 2015 and 2019, were analyzed. Anastomotic leakage was the primary outcome parameter. Inflammation at the resection margin was characterized as "inflammation at proximal resection margin", "inflammation at distal resection margin" or "inflammation at both ends".Results46 patients (35.4%) showed microscopic inflammation at the resection margins. 17 patients (13.1%) developed anastomotic leakage. No difference in the rate of anastomotic leakages was found for proximally affected resection margins (no anastomotic leakage vs. anastomotic leakage: 20.3 vs. 35.3%, p = 0.17), distally affected resection margins (2.7 vs. 5.9%, p = 0.47) or inflammation at both ends (9.7 vs. 11.8%, p = 0.80). No effect on the anastomotic leakage rate was found for preoperative hemoglobin concentration (no anastomotic leakage vs. anastomotic leakage: 12.3 vs. 13.5 g/dl, p = 0.26), perioperative immunosuppressive medication (62.8 vs. 52.9%, p = 0.30), BMI (21.8 vs. 22.4 m2/kg, p = 0.82), emergency operation (21.2 vs. 11.8%, p = 0.29), laparoscopic vs. open procedure (p = 0.58), diverting ileostomy (31.9 vs. 57.1%, p = 0.35) or the level of surgical training (staff surgeon: 80.5 vs. 76.5%, p = 0.45).ConclusionMicroscopic inflammation at the resection margins after ileocecal resection in Crohn's disease is common. Histologically inflamed resection margins do not appear to affect the rate of anastomotic leakages. Our data suggest that there is no need for extensive resections or frozen section to achieve microscopically inflammation-free resection margins.

Project description:BACKGROUND AND OBJECTIVES:Management of postoperative pain after laparoscopic segmental colonic resections remains controversial. We compared 2 methods of analgesia within an Enhanced Recovery After Surgery (ERAS) program. The goal of the study was to investigate whether administration of intrathecal bupivacaine/morphine would lead to an enhanced recovery. METHODS:A single-center, randomized, double-blind controlled trial was performed (NL43488.101.13). Patients scheduled for laparoscopic segmental intestinal resections were considered. Exclusion criteria were patients in whom contraindications to spinal anesthesia were present, conversion to open surgery, and gastric and rectal surgery. The intervention group received single-shot intrathecal bupivacaine/morphine (12.5 mg/300 ?g), with an altered dose for older patients. The control group received a sham procedure and a bolus of piritramide (0.1 mg/kg). Both groups received standardized general anesthesia and a patient-controlled intravenous analgesia pump as postoperative analgesia. All patients were treated according to an ERAS protocol. A decrease in days to "fit for discharge" was the primary outcome. RESULTS:Fifty-six patients were enrolled. Intervention group patients were fit for discharge earlier (median of 3 vs 4 days, P = 0.044). Furthermore, there was a significant decrease in opioid use and lower pain scores on the first postoperative day in the intervention group. There were no differences in adverse events (except for more pruritus), time to mobilization, fluid administration, or patient satisfaction. CONCLUSIONS:This randomized controlled trial shows that intrathecal morphine is a more effective method of postoperative analgesia in laparoscopic surgery than intravenous opioids within an ERAS program. Recovery is faster and less painful with intrathecal morphine. Other studies have confirmed these results, although data on faster recovery are new and require confirmation in future trials. CLINICAL TRIAL REGISTRATION:This study was registered at ClinicalTrials.gov, identifier NCT02284282.

Project description:BACKGROUND:The structures of the mesentery including adipose tissue, nerves, and lymphatics play an important role in the pathogenesis and disease progression of Crohn's disease (CD). Conventional surgical resection for CD usually does not involve resecting the mesentery en bloc with the specimen. This contrasts with complete mesocolic excision (CME) in colorectal cancer, which involves radical resection of the mesentery. Preliminary evidence from smaller studies suggests that applying the principle of mesocolic excision to CD surgery may reduce the risk of postoperative recurrence. This randomized controlled trial is designed to test whether applying the principles of mesocolic excision to CD results in reduced postoperative recurrence. It also aims to evaluate intra- and postoperative morbidity between the two approaches. METHODS:This international, multicenter, randomized controlled trial will randomize patients (n?=?116) scheduled to undergo primary ileocolic resection to either receive extensive mesenteric excision (EME) or conventional ileocolic resection with limited mesenteric excision (LME). Five sites will recruit patients in three countries. In the EME group, the mesentery is resected following CME, while avoiding the root region, i.e., 1?cm from the root of the ileocolic artery and vein. In the LME group, the mesentery is retained, i.e., "close shave" or?<?3?cm from the border of bowel. The primary end point will be surgical recurrence after surgery. The secondary end points will be the postoperative endoscopic and clinical recurrence, and intra- and postoperative morbidity. Demographics, risk factors, laboratory investigations, endoscopy, postoperative prophylaxis and imaging examination will be assessed. Analysis of the primary outcome will be on an intention-to-treat basis. DISCUSSION:If mesocolic excision in CD reduces postoperative disease recurrence and does not increase morbidity, this trial has the potential to change practice and reduce recurrence of CD after surgical resection. TRIAL REGISTRATION:Clinical Trials.gov, ID: NCT03769922. Registered on February 27, 2019.

Project description:INTRODUCTION:Crohn's disease is a chronic inflammatory disease of the gastrointestinal tract with an increasing incidence and prevalence worldwide. The early use of anti--tumour necrosis factor agents, such as infliximab, in patients with an aggressive form of Crohn's disease has become part of routine practice. However, infliximab has limitations, and early surgery might benefit patients more. The objective of this study was to compare laparoscopic bowel resection with infliximab treatment in patients with moderately or severely active Crohn's disease with respect to endoscopic remission. The laparoscopic bowel resection combined with infliximab treatment trial is the first randomised controlled trial to demonstrate if early surgery can improve the outcome of patients with Crohn's disease with limited non-stricturing disease treated with infliximab. METHODS AND ANALYSIS:This is a randomised, open-label, controlled trial at Renji Hospital. In this study, a total of 106 adult patients aged 18-80 years with moderately or severely active and steroid-dependent or steroid-resistant Crohn's disease of the distal ileum will be randomly assigned in a 1:1 ratio to the control and surgery groups. The primary outcome is 12-month endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease in the control group and the Rutgeerts score in the surgery group. The secondary outcomes are clinical remission, surgery rate, quality of life, Crohn's disease-related medical costs and Crohn's disease-related morbidity. The patients will be followed up every 6 months after randomisation through intestinal magnetic resonance enterography and colonoscopy for either 3 years or until clinical remission. ETHICS AND DISSEMINATION:All participants will provide informed consent. The protocol has been approved by the Medical Ethical Committee of the Academic Medical Center in Shanghai (No KY2019-180). Results will be disseminated through peer-reviewed journals and scientific conference presentations. TRIAL REGISTRATION NUMBER:ChiCTR2000029323.

Project description:Background: Patients with Crohn's disease (CD) undergoing bowel resection often suffer from depression and acute pain, which severely impairs their recovery. We aimed to investigate the effects of S-ketamine preconditioning on postoperative depression in patients with CD undergoing a bowel resection with mild to moderate depression and to observe whether it can relieve postoperative pain and anti-inflammation. Methods: A total of 124 adult patients were randomized into one of the two groups. Patients in the S-ketamine group received a 0.25 mg/kg S-ketamine intravenous drip under general anesthesia induction, followed by a continuous infusion of S-ketamine with 0.12 mg/kg/h for more than 30 min through target-controlled infusion. Patients in the placebo group received 0.9% saline at an identical volume and rate. The primary outcome measure was the 17-item Hamilton depression Scale (HAMD-17). The secondary outcomes were scores on the following questionnaires: a nine-item patient health questionnaire (PHQ-9); a quality of recovery (QoR-15) form; and a numeric rating scale (NRS). Additional secondary outcomes included the levels of C-reactive protein (CRP) and interleukin 6 (IL-6) on postoperative days (PODs) 1, 3, and 5, the length of hospital stay, and opioid use throughout the hospital stay. Results: The scores of PHQ-9 and HAMD-17 in the S-ketamine group were lower than those in the placebo group on postoperative days (PODs) 1, 2, and 7 (p < 0.05). The scores of QoR-15 in the S-ketamine group were higher than those in the placebo group on postoperative days (PODs) 3 and 5 (p < 0.05). The NRS scores of PACU, postoperative days 1 and 2 in the S-ketamine group were lower than those in the placebo group (p < 0.05). There was no significant difference in the CRP and IL-6 levels on postoperative days (PODs) 1, 3, and 5, postoperative complications, and hospital stay between the two groups (p > 0.05). Conclusions: The trial indicated that the intraoperative administration of low-dose S-ketamine could alleviate mild-to-moderate depressive symptoms and postoperative pain in patients with Crohn's disease undergoing bowel resection without worsening their safety.

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Laparoscopy Combined with Enhanced Recovery Pathway in Ileocecal Resection for Crohn's Disease: A Randomized Study.

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Laparoscopy Combined with Enhanced Recovery Pathway in Ileocecal Resection for Crohn's Disease: A Randomized Study.

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