Dataset Information

Short-term effects of mobilization on oxygenation in patients after open surgery for pancreatic cancer: a randomized controlled trial.

ABSTRACT:

Background

Despite the unequivocal role of progressive mobilization in post-surgical patient management, its specific effects and timing, particularly after abdominal surgery, remain debated. This study's aim was to examine the short-term effects of mobilization on oxygenation in hemodynamically stable patients after open surgery for pancreatic cancer.

Methods

A randomized controlled clinical trial was conducted in which patients (n = 83) after open pancreatic surgery were randomized to either the same-day mobilization group (mobilized when hemodynamically stable within four hours after surgery) or the next-day mobilization group (mobilized first time in the morning of the first post-operative day). Mobilization was prescribed and modified based on hemodynamic and subjective responses with the goal of achieving maximal benefit with minimal risk. Blood gas samples were taken three times the evening after surgery; and before and after mobilization on the first post-operative day. Spirometry was conducted pre-operatively and on the first post-operative day. Adverse events and length of stay in postoperative intensive care were also recorded.

Results

With three dropouts, 80 patients participated (40 per group). All patients in the same-day mobilization group, minimally sat over the edge of the bed on the day of surgery and all patients (both groups) minimally sat over the edge of the bed the day after surgery. Compared with patients in the next-day mobilization group, patients in the same-day mobilization group required lower FiO₂ and had higher SaO₂/FiO₂ at 1800 h on the day of surgery (p < .05). On the day after surgery, FiO_2, SaO₂/FiO_2, PaO₂/FiO₂, and alveolar-arterial oxygen gradient, before and after mobilization, were superior in the same-day mobilization group (p < 0.05). No differences were observed between groups in PCO₂, pH, spirometry or length stay in postoperative intensive care.

Conclusions

Compared with patients after open pancreatic surgery in the next-day mobilization group, those in the same-day mobilization group, once hemodynamically stable, improved oxygenation to a greater extent after mobilization. Our findings support prescribed progressive mobilization in patients after pancreatic surgery (when hemodynamically stable and titrated to their individual responses and safety considerations), on the same day of surgery to augment oxygenation, potentially helping to reduce complications and hasten functional recovery.

Trial registration

This prospective RCT was carried out at the Sahlgrenska University Hospital, Sweden. The study was approved by the Regional Ethical Review Board in Gothenburg (Registration number: 437-17).

Trial registration

"FoU in Sweden" (Research and Development in Sweden, URL: https://www.researchweb.org/is/vgr ) id: 238701 Registered 13 December 2017 and Clinical Trials (URL:clinicaltrials.gov) NCT03466593. Registered 15 March 2018.

SUBMITTER: Fagevik Olsen M

PROVIDER: S-EPMC8028068 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveTo date, well-designed randomized controlled trials examining the safety, efficacy, and long-term outcomes of single-incision laparoscopic surgery (SILS) for colorectal cancer are scarce. The aim of the current study was to compare short-term outcomes of SILS for colorectal cancer with conventional laparoscopic surgery (CLS).MethodsBetween June 28, 2017, and June 29, 2019, a single-center, open-label, non-inferiority, randomized clinical trial was conducted at the Department of General Surgery, Ruijin Hospital (North), Shanghai Jiaotong University School of Medicine in Shanghai, China. In total, 200 patients diagnosed or suspected of colorectal cancer (cT1-4aN0-2M0) were randomly assigned to either the SILS or CLS group in a 1:1 ratio. The primary outcome was early morbidity rate. Secondary outcomes included intraoperative outcomes, pain intensity, postoperative recovery, pathologic outcomes, and long-term outcomes.ResultsIn total, 193 participants (SILS, 97; CLS, 96) were analyzed in the modified intention-to-treat (MITT) population. Among them, 48 underwent right hemicolectomy (SILS n = 23, 23.7% and MLS n = 25, 26%), 15 underwent left hemicolectomy (SILS n = 6, 6.2% and MLS n = 9, 9.4%), 1 underwent transverse colectomy (MLS n = 1, 1%), 57 underwent sigmoidectomy (SILS n = 32, 33% and MLS n = 25, 26%), and 72 underwent anterior resection (SILS n = 36, 37.1% and MLS n = 36, 37.5%). No significant differences were observed in the baseline characteristics. The intraoperative complication was comparable between the two groups [5 (5.2%) vs. 4 (4.2%); difference, 1%; 95% CI, -5.8% to 7.8%; p > 0.999) and so was postoperative complication rates [10 (10.3%) vs. 14 (14.6%); difference, -4.3%; 95% CI, -13.9% to 5.3%; p = 0.392]. The SILS group showed shorter incision length [median (IQR), 4 (3.5-5) vs. 6.6 (6-7.5), p < 0.001] and lower VAS scores on the first [median (IQR), 4 (3-5) vs. 4 (4-5), p = 0.002] and the second day [median (IQR), 2 (1.5-3) vs. 3 (2-4), p < 0.001] after surgery. No statistically significant difference was found in other measured outcomes.ConclusionsCompared with CLS, SILS performed by experienced surgeons for selected colorectal cancer patients is non-inferior with good short-term safety and has the advantage of reducing postoperative pain.Clinical trial registrationClinicalTrials.gov, identifier NCT03151733.

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Dataset Information

Short-term effects of mobilization on oxygenation in patients after open surgery for pancreatic cancer: a randomized controlled trial.

Background

Methods

Results

Conclusions

Trial registration

Trial registration

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