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A randomized study comparing outcomes of stapled and hand-sutured anastomoses in patients undergoing open gastrointestinal surgery.

ABSTRACT: Although stapling is an alternative to hand-suturing in gastrointestinal surgery, recent trials specifically designed to evaluate differences between the two in surgery time, anastomosis time, and return to bowel activity are lacking. This trial compared the outcomes of the two in subjects undergoing open gastrointestinal surgery. Adult subjects undergoing emergency or elective surgery requiring a single gastric, small, or large bowel anastomosis were enrolled into this open-label, prospective, randomized, interventional, parallel, multicenter, controlled trial. Randomization was assigned in a 1:1 ratio between the hand-sutured group (n?=?138) and the stapled group (n?=?142). Anastomosis time, surgery time, and time to bowel activity were collected and compared as primary endpoints. A total of 280 subjects were enrolled from April 2009 to September 2010. Only the time of anastomosis was significantly different between the two arms: 17.6?±?1.90 min (stapled) and 20.6?±?1.90 min (hand-sutured). This difference was deemed not clinically or economically meaningful. Safety outcomes and other secondary endpoints were similar between the two arms. Mechanical stapling is faster than hand-suturing for the construction of gastrointestinal anastomoses. Apart from this, stapling and hand-suturing are similar with respect to the outcomes measured in this trial.

SUBMITTER: Chandramohan SM

PROVIDER: S-EPMC3726813 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature

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A randomized study comparing outcomes of stapled and hand-sutured anastomoses in patients undergoing open gastrointestinal surgery.

Chandramohan S M SM Gajbhiye Raj Narenda RN Agwarwal Anil A Creedon Erin E Schwiers Michael L ML Waggoner Jason R JR Tatla Daljit D

The Indian journal of surgery 20120426 4

Although stapling is an alternative to hand-suturing in gastrointestinal surgery, recent trials specifically designed to evaluate differences between the two in surgery time, anastomosis time, and return to bowel activity are lacking. This trial compared the outcomes of the two in subjects undergoing open gastrointestinal surgery. Adult subjects undergoing emergency or elective surgery requiring a single gastric, small, or large bowel anastomosis were enrolled into this open-label, prospective, ...[more]

PMID: 24426460

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Project description:BACKGROUND:Anastomotic leak is a devastating postoperative complication following rectal anastomoses associated with significant clinical and oncological implications. As a result, there is a need for novel intraoperative methods that will help predict anastomotic leak. METHODS:From 2011 to 2014, patient undergoing rectal anastomoses by colorectal surgeons at our institution underwent prospective application of intraoperative flexible endoscopy with mucosal grading. Retrospective review of patient medical records was performed. After creation of the colorectal anastomosis, application of a three-tier endoscopic mucosal grading system occurred. Grade 1 was defined as circumferentially normal appearing peri-anastomotic mucosa. Grade 2 was defined as ischemia or congestion involving <30% of either the colon or rectal mucosa. Grade 3 was defined as ischemia or congestion involving >30% of the colon or rectal mucosa or ischemia/congestion involving both sides of the staple line. RESULTS:From 2011 to 2014, a total of 106 patients were reviewed. Grade 1 anastomoses were created in 92 (86.7%) patients and Grade 2 anastomoses were created in 10 (9.4%) patients. All 4 (3.8%) Grade 3 patients underwent immediate intraoperative anastomosis takedown and re-creation, with subsequent re-classification as Grade 1. Demographic and comorbidity data were similar between Grade 1 and Grade 2 patients. Anastomotic leak rate for the entire cohort was 12.2%. Grade 1 patients demonstrated a leak rate of 9.4% (9/96) and Grade 2 patients demonstrated a leak rate of 40% (4/10). Multivariate logistic regression associated Grade 2 classification with an increased risk of anastomotic leak (OR 4.09, 95% CI 1.21-13.63, P = 0.023). CONCLUSION:Endoscopic mucosal grading is a feasible intraoperative technique that has a role following creation of a rectal anastomosis. Identification of a Grade 2 or Grade 3 anastomosis should provoke strong consideration for immediate intraoperative revision.

Project description:IntroductionThe aim of this study was to develop a reliable objective structured assessment of technical skills (OSATS) score for linear-stapled, hand-sewn closure of enterotomy intestinal anastomoses (A-OSATS).Materials and methodsThe Delphi methodology was used to create a traditional and weighted A-OSATS score highlighting the more important steps for patient outcomes according to an international expert consensus. Minimally invasive novices, intermediates, and experts were asked to perform a minimally invasive linear-stapled intestinal anastomosis with hand-sewn closure of the enterotomy in a live animal model either laparoscopically or robot-assisted. Video recordings were scored by two blinded raters assessing intrarater and interrater reliability and discriminative abilities between novices (n = 8), intermediates (n = 24), and experts (n = 8).ResultsThe Delphi process included 18 international experts and was successfully completed after 4 rounds. A total of 4 relevant main steps as well as 15 substeps were identified and a definition of each substep was provided. A maximum of 75 points could be reached in the unweighted A-OSATS score and 170 points in the weighted A-OSATS score respectively. A total of 41 anastomoses were evaluated. Excellent intrarater (r = 0.807-0.988, p < 0.001) and interrater (intraclass correlation coefficient = 0.923-0.924, p < 0.001) reliability was demonstrated. Both versions of the A-OSATS correlated well with the general OSATS and discriminated between novices, intermediates, and experts defined by their OSATS global rating scale.ConclusionWith the weighted and unweighted A-OSATS score, we propose a new reliable standard to assess the creation of minimally invasive linear-stapled, hand-sewn anastomoses based on an international expert consensus. Validity evidence in live animal models is provided in this study. Future research should focus on assessing whether the weighted A-OSATS exceeds the predictive capabilities of patient outcomes of the unweighted A-OSATS and provide further validity evidence on using the score on different anastomotic techniques in humans.

Project description:Abstract Aim Frailty assessment in elderly patients is crucial to predict the postoperative course, considering that frailty is highly associated with postoperative complications and mortality. The aim of this study was to evaluate the value of osteopenia as a risk factor for severe postoperative complications in elderly patients who underwent emergency gastrointestinal surgery. Methods This study comprised 103 elderly patients who underwent emergency gastrointestinal surgery. Osteopenia was diagnosed by measuring bone mineral density, which was calculated as the average pixel density in the midvertebral core at the 11th thoracic vertebra on the preoperative plain computed tomography image. We retrospectively investigated the relationship between preoperative osteopenia and severe postoperative complications (Clavien–Dindo classification ≥III). Univariate and multivariate analyses were performed to evaluate the risk factors for severe postoperative complications. Results Twenty‐three patients (22.3%) developed severe postoperative complications. The optimal cutoff value of bone mineral density for severe postoperative complications was 119.5 Hounsfield unit (HU) and 39 patients (37.9%) were diagnosed with osteopenia. The univariate analysis revealed that the American Society of Anesthesiologists Physical Status of ≥3 (P = .0084), hemoglobin levels (P = .0026), albumin levels (P < .001), sarcopenia (P = .015), and osteopenia (P < .001) were significantly associated with severe postoperative complications. The multivariate analysis showed that osteopenia (P = .014) was an independent risk factor for severe postoperative complications. Conclusion Osteopenia may be a risk factor for severe postoperative complications in elderly patients after emergency gastrointestinal surgery. The aim of this study is to evaluate the value of osteopenia for severe postoperative complications in elderly patients who underwent emergency gastrointestinal surgery. In the multivariate analysis, osteopenia was an independent risk factor for severe postoperative complications. Osteopenia may be a risk factor for severe postoperative complications in elderly patients after emergency gastrointestinal surgery.

Project description:BackgroundThe effect of a combination of a goal-directed fluid protocol and preoperative carbohydrate loading on postoperative complications in elderly patients still remains unknown. Therefore, we designed this trial to evaluate the relative impact of preoperative carbohydrate loading and intraoperative goal-directed fluid therapy versus conventional fluid therapy (CFT) on clinical outcomes in elderly patients following gastrointestinal surgery.MethodsThis prospective randomized controlled trial with 120 patients over 65 years undergoing gastrointestinal surgery were randomized into a CFT group (n = 60) with traditional methods of fasting and water-deprivation, and a GDFT group (n = 60) with carbohydrate (200 ml) loading 2 h before surgery. The CFT group underwent routine monitoring during surgery, however, the GDFT group was conducted by a Vigileo/FloTrac monitor with cardiac index (CI), stroke volume variation (SVV), and mean arterial pressure (MAP). For all patients, demographic data, intraoperative parameters and postoperative outcomes were recorded.ResultsPatients in the GDFT group received significantly less crystalloids fluid (1111 ± 442.9 ml vs 1411 ± 412.6 ml; p < 0.001) and produced significantly less urine output (200 ml [150-300] vs 400 ml [290-500]; p < 0.001) as compared to the CFT group. Moreover, GDFT was associated with a shorter average time to first flatus (56 ± 14.1 h vs 64 ± 22.3 h; p = 0.002) and oral intake (72 ± 16.9 h vs 85 ± 26.8 h; p = 0.011), as well as a reduction in the rate of postoperative complications (15 (25.0%) vs 29 (48.3%) patients; p = 0.013). However, postoperative hospitalization or hospitalization expenses were similar between groups (p > 0.05).ConclusionsFocused on elderly patients undergoing open gastrointestinal surgery, we found perioperative fluid optimisation may be associated with improvement of bowel function and a lower incidence of postoperative complications.Trial registrationChiCTR, ChiCTR1800018227 . Registered 6 September 2018 - Retrospectively registered.

Dataset Information

A randomized study comparing outcomes of stapled and hand-sutured anastomoses in patients undergoing open gastrointestinal surgery.

Publications

A randomized study comparing outcomes of stapled and hand-sutured anastomoses in patients undergoing open gastrointestinal surgery.

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