Dataset Information

Effects of Rowachol on prevention of postcholecystectomy pain after laparoscopic cholecystectomy: prospective multicenter randomized controlled trial.

ABSTRACT:

Background

Postcholecystectomy pain (PCP) is characterized by abdominal pain after cholecystectomy. However, prevention of PCP is not well known yet. The purpose of this study was to determine whether Rowachol might be useful in preventing PCP.

Methods

Between May 2013 and January 2014, a total of 138 patients with gallbladder disease who were scheduled to undergo laparoscopic cholecystectomy were randomly assigned to orally receive 100 mg Rowachol or placebo three times daily for 3 months after surgery. Abdominal pain was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire.

Results

Incidence of PCP in the placebo group (n = 9, 14.3%) was higher than that in the Rowachol group (n = 3, 4.7%) with statistically marginal significance (P = 0.08). Risk factor analysis implicated PCP with increased difficulty in performing LC, more frequent pathology with acute cholecystitis, and absence of postoperative Rowachol treatment. Multivariate analysis revealed that greater difficulty of laparoscopic cholecystectomy (HR = 5.78, 95% CI 1.36-24.40, P < 0.05), and absence of postoperative Rowachol treatment (HR = 2.54, 95% CI 1.10-10.39, P < 0.05) were independent risk factors for development of PCP.

Conclusion

Rowachol might be beneficial for prevention of PCP after laparoscopic cholecystectomy.

SUBMITTER: Han IW

PROVIDER: S-EPMC4972378 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Publications

Effects of Rowachol on prevention of postcholecystectomy pain after laparoscopic cholecystectomy: prospective multicenter randomized controlled trial.

Han In Woong IW Kwon O Choel OC Oh Min Gu MG Choi Yoo Shin YS Lee Seung Eun SE

HPB : the official journal of the International Hepato Pancreato Biliary Association 20160630 8

<h4>Background</h4>Postcholecystectomy pain (PCP) is characterized by abdominal pain after cholecystectomy. However, prevention of PCP is not well known yet. The purpose of this study was to determine whether Rowachol might be useful in preventing PCP.<h4>Methods</h4>Between May 2013 and January 2014, a total of 138 patients with gallbladder disease who were scheduled to undergo laparoscopic cholecystectomy were randomly assigned to orally receive 100 mg Rowachol or placebo three times daily for ...[more]

PMID: 27485060

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Project description:BackgroundRecent meta-analyses concluded that antibiotic prophylaxis is not warranted in low-risk laparoscopic cholecystectomy. However, most trials in the meta-analyses had a relatively small sample size and were statistically underpowered. In addition, many of the trials mentioned potential cost savings owing to the elimination of prophylactic antibiotics. However, no trial has statistically estimated the cost effectiveness. To evaluate the results of meta-analyses, we conducted a randomized controlled trial on the role of prophylactic antibiotics in low-risk laparoscopic cholecystectomy with an adequate sample size.MethodsFrom March 2007 to May 2013, at the Department of Surgery, Kansai Medical University, patients who were scheduled for elective laparoscopic cholecystectomy were randomly assigned to one of two arms: those who were and were not administered prophylactic antibiotics. The primary endpoint was the occurrence of postoperative infections and secondary endpoints were postoperative hospital stay and medical costs.FindingsDuring the study period, 518 patients were assigned to the Antibiotics group and 519 to the No antibiotics group. Occurrences of surgical site infections, distant infections and overall infections were significantly lower in the Antibiotics group than in the No antibiotics group (0.8 vs. 3.7%, p = 0.001, OR: 0.205 (95%CI: 0.069 to 0.606); 0.4 vs. 3.1%, p = 0.0004, OR: 0.122 (95%CI: 0.028 to 0.533); 1.2 vs. 6.7%; p<0.0001, OR: 0.162 (95%CI: 0.068 to 0.389), respectively). The postoperative hospital stay was significantly shorter in the Antibiotics group (mean, SD: 3.69±1.56 vs. 4.07±3.00; p = 0.01) and the postoperative medical costs were significantly lower in the Antibiotics group (mean, SD: $766±341 vs. 832±670; p = 0.047). Multivariable analysis showed that independent risk factors for postoperative infectious complications were no prophylactic antibiotics (p<0.0001) and age 65 or older (p = 0.006).ConclusionsPerioperative administration of prophylactic antibiotics should be recommended in laparoscopic cholecystectomy to prevent postoperative infectious complications and to reduce medical costs.Trial registrationUMIN Clinical Trials Registry UMIN000003749.

Project description:BackgroundLocal anaesthetic infiltration is widely used to reduce pain after laparoscopic cholecystectomy (LC). This trial evaluated the effect of depth of local anaesthetic infiltration on postoperative pain reduction after LC.MethodsPatients undergoing elective LC between March 2018 and February 2019 were randomized into no infiltration, subcutaneous infiltration, and rectus sheath infiltration using bupivacaine. The primary outcome was 24-h postoperative cumulative morphine use, and the secondary outcomes were mean 24-h Numerical Rating Scale (NRS) for pain, and nausea, and vomiting. Subgroups were compared and multivariable analyses were performed.ResultsOut of 170 eligible patients, 162 were selected and 150 patients were analysed: 48 in the no-infiltration group, 50 in the subcutaneous infiltration group, and 52 in the rectus sheath infiltration group. The groups had similar clinical features, although mean BMI was higher in the subcutaneous infiltration group (P = 0.001). The 24-h cumulative morphine use in the rectus sheath infiltration group was significantly lower than in the no-infiltration group (P = 0.043), but no difference was observed between the subcutaneous infiltration and no-infiltration groups (P = 0.999). One hour after surgery, the rectus sheath infiltration group had a significantly lower NRS score than the no-infiltration and subcutaneous infiltration groups respectively (P = 0.006 and P = 0.031); however, the score did not differ among the three groups at any of the time points from 2 h after the surgery. The incidence of nausea or vomiting was comparable among the three groups. Multivariable analysis documented that a lower dose of morphine use was associated with rectus sheath infiltration (P = 0.004) and diabetes (P = 0.001); whereas, increased morphine use was associate with age (P = 0.040) and a longer duration of surgery (P = 0.007).ConclusionsLocal anaesthetic infiltration into the rectus sheath reduced postoperative cumulative morphine use and the immediate NRS score in patients undergoing LC; however, the pain scores were comparable 2 h after surgery.Registration numberTCTR20201103002 (http://www.thaiclinicaltrials.org).

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Dataset Information

Effects of Rowachol on prevention of postcholecystectomy pain after laparoscopic cholecystectomy: prospective multicenter randomized controlled trial.

Background

Methods

Results

Conclusion

Publications

Effects of Rowachol on prevention of postcholecystectomy pain after laparoscopic cholecystectomy: prospective multicenter randomized controlled trial.

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