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Laparoscopic versus open adhesiolysis for small bowel obstruction - a multicenter, prospective, randomized, controlled trial.

ABSTRACT: Laparoscopic adhesiolysis is emerging as an alternative for open surgery in adhesive small bowel obstruction. Retrospective studies suggest that laparoscopic approach shortens hospital stay and reduces complications in these patients. However, no prospective, randomized, controlled trials comparing laparoscopy to open surgery have been published.This is a multicenter, prospective, open label, randomized, controlled trial comparing laparoscopic adhesiolysis to open surgery in patients with computed-tomography diagnosed adhesive small bowel obstruction that is not resolving with conservative management. The primary study endpoint is the length of postoperative hospital stay in days.Sample size was estimated based on preliminary retrospective cohort, which suggested that 102 patients would provide 80% power to detect a difference of 2.5 days in the length of postoperative hospital stay with significance level of 0.05. Secondary endpoints include passage of stool, commencement of enteral nutrition, 30-day mortality, complications, postoperative pain, and the length of sick leave. Tertiary endpoints consist of the rate of ventral hernia and the recurrence of small bowel obstruction during long-term follow-up. Long-term follow-up by letter or telephone interview will take place at 1, 5, and 10 years.To the best of our knowledge, this trial is the first one aiming to provide level Ib evidence to assess the use of laparoscopy in the treatment of adhesive small bowel obstruction.ClinicalTrials.gov identifier: NCT01867528. Date of registration May 26th 2013.

SUBMITTER: Sallinen V

PROVIDER: S-EPMC4198325 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Laparoscopic versus open adhesiolysis for small bowel obstruction - a multicenter, prospective, randomized, controlled trial.

Sallinen Ville V Wikström Heidi H Victorzon Mikael M Salminen Paulina P Koivukangas Vesa V Haukijärvi Eija E Enholm Berndt B Leppäniemi Ari A Mentula Panu P

BMC surgery 20141011

<h4>Background</h4>Laparoscopic adhesiolysis is emerging as an alternative for open surgery in adhesive small bowel obstruction. Retrospective studies suggest that laparoscopic approach shortens hospital stay and reduces complications in these patients. However, no prospective, randomized, controlled trials comparing laparoscopy to open surgery have been published.<h4>Methods/design</h4>This is a multicenter, prospective, open label, randomized, controlled trial comparing laparoscopic adhesiolys ...[more]

PMID: 25306234

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Project description:BackgroundSelected patients with adhesion-related chronic abdominal pain can be treated effectively by adhesiolysis with the application of adhesion barriers. These patients might also have an increased risk to develop adhesive small bowel obstruction (ASBO). It is unknown how frequently these patients develop ASBO, and how elective adhesiolysis for pain impacts the risk of ASBO.MethodsPatients with adhesion-related chronic pain were included in this cohort study with long-term follow-up. The diagnosis of adhesions was confirmed using CineMRI. The decision for operative treatment of adhesions was made by shared agreement based on the correlation of complaints with CineMRI findings. The primary outcome was the 5-years incidence of readmission for ASBO. Incidence was compared between patients with elective adhesiolysis and those treated non-operatively and between patients with and without previous ASBO. Univariable and multivariable Cox regression analysis was performed to identify predictive factors for ASBO. Secondary outcomes included reoperation for ASBO and self-reported pain and other abdominal symptoms.ResultsA total of 122 patients were included, 69 patients underwent elective adhesiolysis. Thirty patients in both groups had previous episodes of ASBO in history. During 5-year follow-up, the readmission rate for ASBO was 6.5% after elective adhesiolysis compared to 26.9% after non-operative treatment (p = 0.012). These percentages were 13.3% compared to 40% in the subgroup of patients with previous episodes of ASBO (p = 0.039). In multivariable analysis, elective adhesiolysis was associated with a decreased risk of readmission for ASBO with an odds ratio of 0.21 (95% CI 0.07-0.65), the risk was increased in patients with previous episodes with a odds ratio of 19.2 (95% CI 2.5-144.4). There was no difference between the groups in the prevalence of self-reported abdominal pain. However, in surgically treated patients the impact of pain on daily activities was lower, and the incidence of other symptoms was lower.ConclusionMore than one in four patients with chronic adhesion-related pain develop episodes of ASBO when treated non-operatively. Elective adhesiolysis reduces the incidence of ASBO in patients with chronic adhesion-related symptoms, both in patients with and without previous episodes of ASBO in history. Trial registration The study was registered at Clinicaltrials.gov under NCT01236625.

Project description:For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy.The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (?18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n?=?210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness.In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5 years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient.NCT02248519.

Project description:IntroductionWe compare open pyeloplasty (OP) versus laparoscopic pyeloplasty (LP) in children in a multicenter, prospective, case-control study.Materials and methodsFrom May 2007 to March 2009, a program was established at Hospital Garrahan, the reference center, to perform LP with a mentoring surgeon that would attend the institution once a month. Every new case of ureteropelvic junction obstruction (UPJO) diagnosed in the reference institution was offered to participate in the study. If the patient was enrolled, it was scheduled for LP. The following patient diagnosed with UPJO was operated on with open technique and served as a case-control. In three other facilities, patients were only offered LP and had a matched control open case at the reference institution. The first end point of the study was patient recovery: analgesia requirement and length of hospitalization (LOH). The second end point of the study was resolution of UPJO in long-term follow-up for the two techniques. Demographic data, surgical time, perioperative complications, analgesia requirement, analgesia score during hospitalization, LOH, and outcome were recorded. Both groups received the same postoperative indications for pain control. Parents were asked to assess pain in their children every 4 h postoperatively and to complete a pain scale chart to which the nurses were blinded.ResultsFifteen OP and 15 LP were compared. Groups were similar with regard to sex, age, weight, and laterality. Mean surgical time was longer in LP than in OP group (mean 188 versus 65 min) (p < 0.01). Hospitalization was shorter for LP group with a mean of 1.9 versus 2.5 days for OP group (p < 0.05). Postoperative analgesia requirement was significantly higher in the OP group with a mean use of morphine of 1.7 versus 0.06 mg/kg in the LP group (p < 0.05). Pain scores were similar in both the groups. At a mean follow-up of 58 months there were no failures.ConclusionIn this prospective comparative cohort, LP was a longer procedure than OP. Both procedures had the same efficacy and complication rates, but patients undergoing LP needed fewer narcotics for pain control and had a shorter hospitalization.

Project description:BackgroundSmall bowel obstruction is a common surgical emergency, and is associated with high levels of morbidity and mortality across the world. The literature provides little information on the conservatively managed group. The aim of this study was to describe the burden of small bowel obstruction in the UK.MethodsThis prospective cohort study was conducted in 131 acute hospitals in the UK between January and April 2017, delivered by trainee research collaboratives. Adult patients with a diagnosis of mechanical small bowel obstruction were included. The primary outcome was in-hospital mortality. Secondary outcomes included complications, unplanned intensive care admission and readmission within 30 days of discharge. Practice measures, including use of radiological investigations, water soluble contrast, operative and nutritional interventions, were collected.ResultsOf 2341 patients identified, 693 (29·6 per cent) underwent immediate surgery (within 24 h of admission), 500 (21·4 per cent) had delayed surgery after initial conservative management, and 1148 (49·0 per cent) were managed non-operatively. The mortality rate was 6·6 per cent (6·4 per cent for non-operative management, 6·8 per cent for immediate surgery, 6·8 per cent for delayed surgery; P = 0·911). The major complication rate was 14·4 per cent overall, affecting 19·0 per cent in the immediate surgery, 23·6 per cent in the delayed surgery and 7·7 per cent in the non-operative management groups (P < 0·001). Cox regression found hernia or malignant aetiology and malnutrition to be associated with higher rates of death. Malignant aetiology, operative intervention, acute kidney injury and malnutrition were associated with increased risk of major complication.ConclusionSmall bowel obstruction represents a significant healthcare burden. Patient-level factors such as timing of surgery, acute kidney injury and nutritional status are factors that might be modified to improve outcomes.

Dataset Information

Laparoscopic versus open adhesiolysis for small bowel obstruction - a multicenter, prospective, randomized, controlled trial.

Publications

Laparoscopic versus open adhesiolysis for small bowel obstruction - a multicenter, prospective, randomized, controlled trial.

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