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Background Laparoscopic surgery has been widely accepted for the treatment of colorectal cancer; however, long-term outcomes in elderly patients remain controversial. The midterm results of a randomized trial comparing open surgery with laparoscopic surgery in elderly patients with colorectal cancer are presented. Methods This was a randomized trial comparing open surgery with laparoscopic surgery in elderly patients with colorectal cancer. The primary outcome was complication rate, and secondary outcomes included 3-year recurrence-free survival and overall survival. A total of 200 patients were randomly assigned to open surgery or laparoscopic surgery between 2008 and 2012. The main study objective was to compare the midterm outcomes of open surgery with those of laparoscopic surgery in elderly patients with colorectal cancer. This trial is registered with Clinical Trials.gov (NCT01862562). Results There were no differences between the laparoscopic surgery group and open surgery group in the 3-year overall survival rate (91.5% for laparoscopic surgery vs. 90.6% for open surgery, p  = 0.638) or the 3-year recurrence-free survival rate (84.8% for laparoscopic surgery vs. 88.2% for open surgery, p  = 0.324). The local recurrence rate was significantly higher in the laparoscopic surgery group than in the open surgery group in rectal cancer (13.8% for laparoscopic surgery vs. 0% for open surgery, p  = 0.038). In subgroup analysis according to tumor location, there were no significant differences in the 3-year overall survival rate or 3-year recurrence-free survival rate between the two treatment groups. Conclusion The midterm outcomes of laparoscopic surgery are similar to those of open surgery in elderly patients with colorectal cancer.

BackgroundThe transversus abdominis plane (TAP) block is an important non-narcotic adjunct for post-operative pain control in abdominal surgery. Surgeons can use laparoscopic guidance for TAP block placement (LTAP), however, direct comparisons to conventional ultrasound-guided TAP (UTAPs) have been lacking. The aim of this study is to determine if surgeon placed LTAPs were non-inferior to anesthesia placed UTAPs for post-operative pain control in laparoscopic colorectal surgery.MethodsThis was a prospective, randomized, patient and observer blinded parallel-arm non-inferiority trial conducted at a single tertiary academic center between 2016 and 2018 on adult patients undergoing laparoscopic colorectal surgery. Narcotic consumption and pain scores were compared for LTAP vs. UTAP for 48 h post-operatively.Results60 patients completed the trial (31 UTAP, 29 LTAP) of which 25 patients were female (15 UTAP, 10 LTAP) and the mean ages (SD) were 60.0 (13.6) and 61.5 (14.3) in the UTAP and LTAP groups, respectively. There was no significant difference in post-operative narcotic consumption between UTAP and LTAP at the time of PACU discharge (median [IQR] milligrams of morphine, 1.8 [0–4.5] UTAP vs. 0 [0–8.7] LTAP P = .32), 6 h post-operatively (5.4 [1.8–17.1] UTAP vs. 3.6 [0–12.6] LTAP P = .28), at 12 h post-operatively (9.0 [3.6–29.4] UTAP vs. 7.2 [0.9–22.5] LTAP P = .51), at 24 h post-operatively (9.0 [3.6–29.4] UTAP vs. 7.2 [0.9–22.5] LTAP P = .63), and 48 h post-operatively (39.9 [7.5–70.2] UTAP vs. 22.2 [7.5–63.8] LTAP P = .41). Patient-reported pain scores as well as pre-, intra-, and post-operative course were similar between groups. Non-inferiority criteria were met at all post-op time points up to and including 24 h but not at 48 h.ConclusionsSurgeon-delivered LTAPs are safe, effective, and non-inferior to anesthesia-administered UTAPs in the immediate post-operative period.Trial registryThe trial was registered at clinicaltrials.gov Identifier NCT03577912.

AbstractObjectiveTo investigate whether oral antimicrobial prophylaxis as an adjunct to intravenous antibiotic prophylaxis reduces surgical site infections after elective colorectal surgery.DesignMulticentre, randomised, double blind, placebo controlled trial.Setting11 university and non-university hospitals in France between 25 May 2016 and 8 August 2019.Participants926 adults scheduled for elective colorectal surgery.InterventionPatients were randomised to receive either a single 1 g dose of ornidazole (n=463) or placebo (n=463) orally 12 hours before surgery, in addition to intravenous antimicrobial prophylaxis before surgical incision.Main outcome measuresThe primary outcome was the proportion of patients with surgical site infection within 30 days after surgery. Secondary outcomes included individual types of surgical site infections and major postoperative complications (Clavien-Dindo classification grade 3 or higher) within 30 days after surgery.ResultsOf the 960 patients who were enrolled, 926 (96%) were included in the analysis. The mean age of participants was 63 years and 554 (60%) were men. Surgical site infection within 30 days after surgery occurred in 60 of 463 patients (13%) in the oral prophylaxis group and 100 of 463 (22%) in the placebo group (absolute difference −8.6%, 95% confidence interval −13.5% to −3.8%; relative risk 0.60, 95% confidence interval 0.45 to 0.80). The proportion of patients with deep infections was 4.8% in the oral prophylaxis group and 8.0% in the placebo group (absolute difference −3.2%, 95% confidence interval −6.4% to −0.1%). The proportion of patients with organ space infections was 5.0% in the oral prophylaxis group and 8.4% in the placebo group (absolute difference −3.4%, −6.7% to −0.2%). Major postoperative complications occurred in 9.1% patients in the oral prophylaxis group and 13.6% in the placebo group (absolute difference −4.5%, −8.6% to −0.5%).ConclusionAmong adults undergoing elective colorectal surgery, the addition of a single 1 g dose of ornidazole compared with placebo before surgery significantly reduced surgical site infections.Trial registrationClinicalTrials.gov NCT02618720.

BackgroundIntraoperative ureteral injury, a serious complication of abdominopelvic surgeries, can be avoided through ureter visualization. Near-infrared fluorescence imaging offers real-time anatomical visualization of ureters during surgery. Pudexacianinium (ASP5354) chloride is an indocyanine green derivative under investigation for intraoperative ureter visualization during colorectal or gynecologic surgery in adult and pediatric patients.MethodsIn this phase 2 study (NCT04238481), adults undergoing laparoscopic colorectal surgery were randomized to receive one intravenous dose of pudexacianinium 0.3 mg, 1.0 mg, or 3.0 mg. The primary endpoint was successful intraoperative ureter visualization, defined as observation of ureter fluorescence 30 min after pudexacianinium administration and at end of surgery. Safety and pharmacokinetics were also assessed.ResultsParticipants received pudexacianinium 0.3 mg (n = 3), 1.0 mg (n = 6), or 3.0 mg (n = 3). Most participants were female (n = 10; 83.3%); median age was 54 years (range 24–69) and median BMI was 29.3 kg/m2 (range 18.7–38.1). Successful intraoperative ureter visualization occurred in 2/3, 5/6, and 3/3 participants who received pudexacianinium 0.3 mg, 1.0 mg, or 3.0 mg, respectively. Median intensity values per surgeon assessment were 1 (mild) with the 0.3-mg dose, 2 (moderate) with the 1.0-mg dose, and 3 (strong) with the 3.0-mg dose. A correlation was observed between qualitative (surgeon’s recognition/identification of the ureter during surgery) and quantitative (video recordings of the surgeries after study completion) assessment of fluorescence intensity. Two participants experienced serious adverse events, none of which were drug-related toxicities. One adverse event (grade 1 proteinuria) was related to pudexacianinium. Plasma pudexacianinium concentrations were dose-dependent and the mean (± SD) percent excreted into urine during surgery was 22.3% ± 8.0% (0.3-mg dose), 15.6% ± 10.0% (1.0-mg dose), and 39.5% ± 12.4% (3.0-mg dose).ConclusionsIn this study, 1.0 and 3.0 mg pudexacianinium provided ureteral visualization for the duration of minimally invasive, laparoscopic colorectal procedures and was safe and well tolerated.

Intraoperative lung-protective ventilation, including low tidal volume and positive end-expiratory pressure, reduces postoperative pulmonary complications. However, the effect and specific alveolar recruitment maneuver method are controversial. We investigated whether the intraoperative intermittent recruitment maneuver further reduced postoperative pulmonary complications while using a lung-protective ventilation strategy. Adult patients undergoing elective laparoscopic colorectal surgery were randomly allocated to the recruitment or control groups. Intraoperative ventilation was adjusted to maintain a tidal volume of 6–8 mL kg −1 and positive end-expiratory pressure of 5 cmH 2 O in both groups. The alveolar recruitment maneuver was applied at three time points (at the start and end of the pneumoperitoneum, and immediately before extubation) by maintaining a continuous pressure of 30 cmH 2 O for 30 s in the recruitment group. Clinical and radiological evidence of postoperative pulmonary complications was investigated within 7 days postoperatively. A total of 125 patients were included in the analysis. The overall incidence of postoperative pulmonary complications was not significantly different between the recruitment and control groups (28.1% vs. 31.1%, P = 0.711), while the mean ± standard deviation intraoperative peak inspiratory pressure was significantly lower in the recruitment group (10.7 ± 3.2 vs. 13.5 ± 3.0 cmH 2 O at the time of CO 2 gas-out, P  < 0.001; 9.8 ± 2.3 vs. 12.5 ± 3.0 cmH 2 O at the time of recovery, P  < 0.001). The alveolar recruitment maneuver with a pressure of 30 cmH 2 O for 30 s did not further reduce postoperative pulmonary complications when a low tidal volume and 5 cmH 2 O positive end-expiratory pressure were applied to patients undergoing laparoscopic colorectal surgery and was not associated with any significant adverse events. However, the alveolar recruitment maneuver significantly reduced intraoperative peak inspiratory pressure. Further study is needed to validate the beneficial effect of the alveolar recruitment maneuver in patients at increased risk of postoperative pulmonary complications. Trial registration: Clinicaltrials.gov ( NCT03681236 ).

Objective To evaluate the effectiveness of preemptive multimodal analgesiain elderly patients undergoing laparoscopic colorectal surgery. Methods A prospective randomized controlled study was conducted in the Department of Gastrointestinal Surgery of the Second Hospital of Hebei Medical University from January 2022 to December 2022. A total of 133 patients were included according to the criteria and randomly divided into preemptive analgesia (PRA) group (test group, 67patients) and postoperative analgesia (POA) group (control group, 66patients). Results The Visual Analog Scale (VAS)scores of PRA group 24 h, 48 h, and 72 h after operation were lower than those of POA group, and the difference was statistically significant, P < 0.001.The incidences of postoperative gastrointestinal dysfunction (POGD) and postoperative delirium (POD)in PRA group were 13.43% and 8.98%, respectively, which were significantly lower than those in POA group (31.82% and 24.24%), P < 0.05. The levels of IL-6 and IL-10 in PRA group after the operation were 17.54 ± 2.13 ng/L and 15.57 ± 1.71 ng/L respectively, which were lower than those in POA group (25.45 ± 2.95 ng/L and 23.45 ± 1.88 ng/L), P < 0.05. The level of acetylcholinesterase(AchE) was 56.34 ± 5.62 nmol/L in the POA group, which was significantly higher than that in the POA group (49.59 ± 5.52 nmol/L), P < 0.001. Conclusion Preemptive multimodal analgesia can reduce the incidence of POGD and POD in elderly patients undergoing laparoscopic gastrocolic surgery, improve the recovery process of postoperative gastrointestinal function, increase the concentrations of propionic acid and butyric acid in short chain fatty acids (SCFAs) and the number of beneficial intestinal bacteria.

IntroductionAnastomotic leakage (AL) is one of the major complications after colorectal surgery. Compromised tissue perfusion at the anastomosis site increases the risk of AL. Several cohort studies have shown that indocyanine green (ICG) combined with fluorescent near-infrared imaging is a feasible and reproducible technique for real-time intraoperative imaging of tissue perfusion, leading to reduced leakage rates after colorectal resection. Unfortunately, these studies were not randomised. Therefore, we propose a randomised controlled trial to assess the value of ICG-guided surgery in reducing AL after colorectal surgery.Methods and analysisA multicentre, randomised controlled clinical trial will be conducted to assess the benefit of ICG-guided surgery in preventing AL. A total of 978 patients scheduled for colorectal surgery will be included. Patients will be randomised between the Fluorescence Guided Bowel Anastomosis group and the Conventional Bowel Anastomosis group. The primary endpoint is clinically relevant AL (defined as requiring active therapeutic intervention or reoperation) within 90 days after surgery. Among the secondary endpoints are 30-day clinically relevant AL, all-cause postoperative complications, all-cause and AL-related mortality, surgical and non-surgical reinterventions, total surgical time, length of hospital stay and all-cause and AL-related readmittance.Ethics and disseminationThis protocol has been approved by the Medical Ethical Committee Leiden-Den Haag-Delft (METC-LDD) and is registered at ClinicalTrials.gov and trialregister.nl. The results of this study will be reported through peer-reviewed publications and conference presentations.Trial registration numberNCT04712032; NL7502.

Prevention of surgical site infections (SSIs) can improve surgical quality through reductions in morbidity and cost. We sought to determine whether the abdominal closure protocol, in isolation, decreases SSI at an academic teaching hospital. Adult patients undergoing laparotomy were prospectively randomized to an abdominal closure protocol, which includes unused sterile instruments and equipment at fascial closure, or usual care. A 30-day SSI rates were compared. General surgery, colorectal, urology, or gynecologic oncology patients undergoing anticipated wound classification II cases were eligible. Overall SSI rates were 11.6% in patients randomized to protocol closure vs 12.4% for usual care (total n = 233; P = .85). The abdominal closure protocol and usual care groups had similar rates of superficial (4.5% vs 4.1%; P = .9), deep (.9% vs 0%, P = .3), organ-space SSI rates (6.2% vs 8.3%, P = .55), and wound dehiscence (2.7% vs 5.3%; P = .24). An abdominal closure protocol did not decrease the rate of SSI and is likely not a key intervention for SSI reduction. •A closing tray used at fascial closure does not decrease surgical site infection.•This study was a prospective randomized quality improvement trial.•A total of 233 patients were randomized to the closing tray or usual care.

Objective This study aimed to investigate the effects of multimodal preemptive analgesia on postoperative gastrointestinal function and clinical outcomes in patients undergoing laparoscopic colorectal surgery. Methods This prospective study included a total of 108 patients undergoing elective laparoscopic colorectal surgery from June 2019 to June 2020. The patients were divided into the control group and the study group according to the random number table method. Patients in the study group were given flurbiprofen axetil and oxycodone before skin incision combined with bilateral transverse abdominis plane block (TAPB) before anaesthesia induction. In the control group, patients were given sufentanil and flurbiprofen axetil combined with bilateral TAPB in postanaesthesia care unit (PACU). The incidence of postoperative gastrointestinal dysfunction (POGD), I‐FEED score, inflammatory factor levels, rehabilitation indicators, postoperative pain assessment and other organ complications were observed and compared between the two groups. Results The incidence of POGD in the study group was lower compared to the control group, and the difference was statistically significant (P < .05). The study group had lower total and mean scores of I‐FEED at 24, 48, 72 and 96 hours after surgery; however, the differences were not statistically significant (P > .05). On the first and third day after operation, Lipopolysaccharide (LPS), C‐reactive protein (CRP), Tumour necrosis factor (TNF‐α) and Interleukins6 (IL‐6) levels of the study group decreased significantly (P < .05). The reduction in inflammation factor levels from 1d to 3d was significantly greater than that of the control group (P < .05). Conclusion The strategy of multimodal preemptive analgesia can effectively prevent the onset of POGD and may accelerate rehabilitation. In short, multimodal preemptive analgesia provides a novel prevention strategy for patients undergoing laparoscopic colorectal surgery.

Background There is scarce literature on the effect of mechanical abdominal massage on the duration of ileus after colectomy, particularly in the era of enhanced recovery after surgery (ERAS). The aim of this study was to determine whether abdominal massage after colorectal surgery with anastomosis and no stoma helps toward a faster return of intestinal transit. Methods This study was a superiority trial and designed as a prospective open-label, single-center, randomized controlled clinical trial with two parallel groups. Patients scheduled to undergo intestinal resection and follow an ERAS protocol were randomly assigned to either the standard ERAS group or the ERAS plus massage group. The primary endpoint was the return of intestinal transit, defined as the first passage of flatus following the operation. Secondary endpoints included time of the first bowel motion, maximal pain, 30 day complications, complications due to massage, anxiety score given by the Hospital Anxiety and Depression (HAD) questionnaire, and quality of life assessed by the EQ-5D-3L questionnaire. Results Between July 2020 and June 2021, 36 patients were randomly assigned to the ERAS group or the ERAS plus massage group ( n  = 19). Patients characteristics were comparable. There was no significant difference in time to passage of the first flatus between the ERAS group and the ERAS plus abdominal massage group (1065 versus 1389 min, p  = 0.274). No statistically significant intergroup difference was noted for the secondary endpoints. Conclusion Our study, despite its limitations, failed to demonstrate any advantage of abdominal massage to prevent or even reduce symptoms of postoperative ileus after colorectal surgery. Trial registration number: 38RC20.021.