| 1. |
- Andersson, Roland, et al.
(author)
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Local Administration of Antibiotics by Gentamicin–Collagen Sponge does not Improve Wound Healing or Reduce Recurrence Rate After Pilonidal Excision with Primary Suture: A Prospective Randomized Controlled Trial
- 2010
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In: World Journal of Surgery. - : Springer Science and Business Media LLC. - 0364-2313 .- 1432-2323. ; 34:12, s. 3042-3046
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Journal article (peer-reviewed)abstract
- Background Excision and primary suture for pilonidal disease is associated with a high rate of wound infection and recurrences. This randomized, controlled study was designed to analyze the effect of local application of a gentamicin-containing collagen sponge (Collatamp®) in reducing the wound infection rate and recurrences after excision of pilonidal sinus and wound closure with primary midline suture. Methods From March 2003 to November 2005, 161 patients with symptomatic pilonidal disease were operated on at 11 hospitals with traditional wide excision of the sinus and all of its tracts. The patients were randomized to filling of the cavity with a gentamicin-containing collagen sponge (Collatamp®) before wound closure or to closure with no additional treatment. Information about the treatment allocation was hidden until the end of the study. Information about wound healing was noted at follow-up at the outpatient department after 2–4 days, 2 weeks, 3 months, and 1 year. Results No statistically significant differences were observed between the groups during follow-up. Patients who received prophylaxis with Collatamp® had slightly fewer wounds with exudate at 2–4 days and 2 weeks of follow-up (2% vs. 10%, p = 0.051 and 57% vs. 65%, p = 0.325, respectively), a slightly larger proportion of healed wounds at 3 months follow-up (77% vs. 66%, p = 0.138) but not at 1 year (85% vs. 90%, p = 0.42, respectively), and slightly more reoperations (10% vs. 4%, p = 0.213). Conclusions This randomized, controlled study showed no significant differences in the rates of wound infection, wound healing, and recurrences when a gentamicin–collagen sponge was added to the surgical treatment of pilonidal disease with excision and primary midline suture. This does not support the use of gentamicin–collagen sponge for the surgical treatment of pilonidal disease. This study was conducted for the Pilonidal Sinus Collatamp study group. Members of the Pilonidal Sinus Collatamp study group are listed in the appendix.
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| 2. |
- Angenete, Eva, 1972, et al.
(author)
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Laparoscopic Lavage Is Feasible and Safe for the Treatment of Perforated Diverticulitis With Purulent Peritonitis The First Results From the Randomized Controlled Trial DILALA
- 2016
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In: Annals of Surgery. - : Lippincott Williams & Wilkins. - 0003-4932 .- 1528-1140. ; 263:1, s. 117-122
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Journal article (peer-reviewed)abstract
- Objective:To evaluate short-term outcomes of a new treatment for perforated diverticulitis with purulent peritonitis in a randomized controlled trial.Background:Perforated diverticulitis with purulent peritonitis (Hinchey III) has traditionally been treated with surgery including colon resection and stoma (Hartmann procedure) with considerable postoperative morbidity and mortality. Laparoscopic lavage has been suggested as a less invasive surgical treatment.Methods:Laparoscopic lavage was compared with colon resection and stoma in a randomized controlled multicenter trial, DILALA (ISRCTN82208287). Initial diagnostic laparoscopy showing Hinchey III was followed by randomization. Clinical data was collected up to 12 weeks postoperatively.Results: Eighty-three patients were randomized, out of whom 39 patients in laparoscopic lavage and 36 patients in the Hartmann procedure groups were available for analysis. Morbidity and mortality after laparoscopic lavage did not differ when compared with the Hartmann procedure. Laparoscopic lavage resulted in shorter operating time, shorter time in the recovery unit, and shorter hospital stay.Conclusions:In this trial, laparoscopic lavage as treatment for patients with perforated diverticulitis Hinchey III was feasible and safe in the short-term.
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| 3. |
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| 4. |
- Danielsen, Anne K, et al.
(author)
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Early Closure of a Temporary Ileostomy in Patients With Rectal Cancer: A Multicenter Randomized Controlled Trial.
- 2017
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In: Annals of surgery. - 1528-1140. ; 265:2, s. 284-290
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Journal article (peer-reviewed)abstract
- The objective was to study morbidity and mortality associated with early closure (8-13 days) of a temporary stoma compared with standard procedure (closure after > 12 weeks) after rectal resection for cancer.A temporary ileostomy may reduce the risk of pelvic sepsis after anastomotic dehiscence. However, the temporary ileostomy is afflicted with complications and requires a second surgical procedure (closure) with its own complications. Early closure of the temporary ileostomy could reduce complications for rectal cancer patients.Early closure (8-13 days after stoma creation) of a temporary ileostomy was compared with late closure (>12 weeks) in a multicenter randomized controlled trial, EASY (www.clinicaltrials.gov, NCT01287637) including patients undergoing rectal resection for cancer. Patients with a temporary ileostomy without signs of postoperative complications were randomized to closure at 8 to 13 days or late closure (>12 weeks after index surgery). Clinical data were collected up to 12 months. Complications were registered according to the Clavien-Dindo Classification of Surgical Complications, and Comprehensive Complication Index was calculated.The trial included 127 patients in eight Danish and Swedish surgical departments, and 112 patients were available for analysis. The mean number of complications after index surgery up to 12 months follow up was significantly lower in the intervention group (1.2) compared with the control group (2.9), P < 0.0001.It is safe to close a temporary ileostomy 8 to 13 days after rectal resection and anastomosis for rectal cancer in selected patients without clinical or radiological signs of anastomotic leakage.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/4.0.
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| 5. |
- Janson, Martin, et al.
(author)
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Analysis of patient selection and external validity in the Swedish contribution to the COLOR trial.
- 2009
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In: Surgical endoscopy. - : Springer Science and Business Media LLC. - 1432-2218 .- 0930-2794. ; 23:8, s. 1764-9
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Journal article (peer-reviewed)abstract
- OBJECTIVE: The colon cancer laparoscopic or open resection (COLOR) trial is an international, randomised controlled trial comparing outcomes of open and laparoscopic surgery for colon cancer. The main purpose of this study was to determine representability by comparing included and nonincluded patients in the participating Swedish centres. DESIGN: At eight centres, which included 391 of the 422 Swedish patients, a local database search was performed to identify retrospectively all patients (n = 2,384) who underwent surgery for colon cancer during the inclusion period, and data was retrieved from medical records. RESULTS: Four hundred fifty-six patients were randomised, 65 of whom were excluded post randomisation (group 2), leaving 391 patients in the study (group 1). For 1,566 patients, valid exclusion criteria were found (group 3). Thus, 362 patients were eligible but not included (group 4). Relative to group 1, patients in group 4 had a significantly higher American Society of Anaesthesiologists (ASA) score, more advanced tumour stage and difference regarding the resections performed. Results showed that 1470 patients (62%) could be calculated as feasible for laparoscopic colon resection (LCR) in a clinical, nontrial situation. CONCLUSIONS: The study population in the Swedish part of the COLOR trial was representative of the eligible population with the exception of comorbidity, where those actually included had less severe comorbidity than the nonincluded but eligible patients. In Sweden, 50-60% of colon cancer patients can be operated on by laparoscopy.
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| 6. |
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| 7. |
- Novik, Bengt, et al.
(author)
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More recurrences after hernia mesh fixation with short-term absorbable sutures: A registry study of 82 015 lichtenstein repairs
- 2011
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In: Archives of surgery. - : American Medical Association (AMA). - 0004-0010 .- 1538-3644. ; 146, s. 12-17
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Journal article (peer-reviewed)abstract
- Objective: To assess the effects of different mesh fixation suture materials on the risk of recurrence after Lichtenstein inguinal hernioplasty. Design: Observational, population-based registry study. Setting: Data from the nationwide Swedish Hernia Registry. Patients: All 82 015 Lichtenstein inguinal hernioplasties with sutured mesh fixation in adolescents and adults (15 years or older) from January 1, 2002, to December 31, 2009, at surgical units enrolled in the Swedish Hernia Registry. Interventions: Mesh fixation with nonabsorbable, long-term absorbable, or short-term absorbable sutures. Main Outcome Measure: Relative risk (RR) for reoperation due to recurrence of a hernia in the same groin during the study period, based on cumulative reoperation rates adjusted for time and confounding variables. Results: For each study group, RR was calculated with multiregression analysis. There was no significant difference in risk for reoperation after mesh fixation with standard nonabsorbable sutures (RR, 1) or with longterm absorbable sutures (RR, 1.12; 95% confidence interval, 0.81-1.55; P=.49). Short-term absorbable sutures, however, more than doubled that risk (RR, 2.23; 95% confidence interval, 1.67-2.99; P<.001). Conclusions: With regard to recurrence risk, long-term absorbable sutures are an excellent alternative to permanent sutures for mesh fixation in Lichtenstein inguinal hernioplasty. Short-term absorbable sutures entail an independent risk factor for recurrence and should therefore be avoided. ©2011 American Medical Association. All rights reserved.
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| 9. |
- Onerup, Aron, 1983, et al.
(author)
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The effect of pre- and post-operative physical activity on recovery after colorectal cancer surgery (PHYSSURG-C): Study protocol for a randomised controlled trial
- 2017
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In: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 18:1
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Journal article (peer-reviewed)abstract
- © 2017 The Author(s).Background: Surgery for colorectal cancer is associated with a high risk of post-operative adverse events, re-operations and a prolonged post-operative recovery. Previously, the effect of prehabilitation (pre-operative physical activity) has been studied for different types of surgery, including colorectal surgery. However, the trials on colorectal surgery have been of limited methodological quality and size. The aim of this trial is to compare the effect of a combined pre- and post-operative intervention of moderate aerobic physical activity and inspiratory muscle training (IMT) with standard care on post-operative recovery after surgery for colorectal cancer. Methods/design: We are conducting a randomised, controlled, parallel-group, open-label, multi-centre trial with physical recovery within 4 weeks after cancer surgery as the primary endpoint. Some 640 patients planned for surgery for colorectal cancer will be enrolled. The intervention consists of pre- and post-operative physical activity with increased daily aerobic activity of moderate intensity as well as IMT. In the control group, patients will be advised to continue their normal daily exercise routine. The primary outcome is patient-reported physical recovery 4 weeks post-operatively. Secondary outcomes are length of sick leave, complication rate and severity, length of hospital stay, re-admittances, re-operations, post-operative mental recovery, quality of life and mortality, as well as changes in insulin-like growth factor 1 and insulin-like growth factor-binding protein 3, perception of pain and a health economic analysis. Discussion: An increase in moderate-intensity aerobic physical activity is a safe, cheap and feasible intervention that would be possible to implement in standard care for patients with colorectal cancer. If shown to be effective, this lifestyle intervention could be a clinical parallel to pre-operative smoke cessation that has already been implemented with good clinical results. Trial registration: ClinicalTrials.gov identifier: NCT02299596. Registered on 17 November 2014.
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| 10. |
- Park, Jennifer, et al.
(author)
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Cost analysis in a randomized trial of early closure of a temporary ileostomy after rectal resection for cancer (EASY trial).
- 2020
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In: Surgical endoscopy. - : Springer Science and Business Media LLC. - 1432-2218 .- 0930-2794. ; 34:1, s. 69-76
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Journal article (peer-reviewed)abstract
- Hospital costs associated with the treatment of rectal cancer are considerable and the formation of a temporary stoma accounts for additional costs. Results from the EASY trial showed that early closure of a temporary ileostomy was associated with significantly fewer postoperative complications but no difference in health-related quality of life up to 12months after rectal resection. The aim of the present study was to perform a cost analysis within the framework of the EASY trial.Early closure (8-13days) of a temporary stoma was compared to late closure (>12weeks) in the randomized controlled trial EASY (NCT01287637). The study period and follow-up was 12months after rectal resection. Inclusion of participants was made after index surgery. Exclusion criteria were diabetes mellitus, steroid treatment, signs of postoperative complications or anastomotic leakage. Clinical effectiveness and resource use were derived from the trial and unit costs from Swedish sources. Costs were calculated for the year 2016 and analysed from the perspective of the healthcare sector.Fifty-five patients underwent early closure, and 57 late closure in eight Swedish and Danish hospitals between 2011 and 2014. The difference in mean cost per patient was 4060 US dollar (95% confidence interval 1121; 6999, p value<0.01) in favour of early closure. A sensitivity analysis, taking protocol-driven examinations into account, resulted in an overall difference in mean cost per patient of $3608, in favour of early closure (95% confidence interval 668; 6549, p value 0.02). The predominant cost factors were reoperations, readmissions and endoscopic examinations.The significant cost reduction in this study, together with results of safety and efficacy from the randomized controlled trial, supports the routine use of early closure of a temporary ileostomy after rectal resection for cancer in selected patients without signs of anastomotic leakage.Registered at clinicaltrials.gov, clinical trials identifier NCT01287637.
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