Allenson Kelvin, Turner Kea, Gonzalez Brian D, Gurd Erin, Zhu Sarah, Misner Nicole, Chin Alicia, Adams Melissa, Cooper Laura, Nguyen Diana, Naffouje Samer, Castillo Diana L, Kocab Maria, James Brian, Denbo Jason, Pimiento Jose M, Malafa Mokenge, Powers Benjamin D, Fleming Jason B, Anaya Daniel A, Hodul Pamela J
Department of Gastrointestinal Oncology, Moffitt Cancer Center, Tampa, Fl, USA.
Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA.
BMC Nutr. 2021 Dec 9;7(1):82. doi: 10.1186/s40795-021-00487-3.
Patients undergoing hepatopancreatobiliary (HPB) surgery, such patients with pancreatic, periampullary, and liver cancer, are at high risk for malnutrition. Malnutrition increases surgical complications and reduces overall survival. Despite its severity, there are limited interventions addressing malnutrition after HPB surgery. The aim of this pilot trial was to examine feasibility, acceptability, usability, and preliminary efficacy of a remote nutrition monitoring intervention after HPB surgery.
Participants received tailored nutritional counseling before and after surgery at 2 and 4 weeks after hospital discharge. Participants also recorded nutritional intake daily for 30 days, and these data were reviewed remotely by registered dietitians before nutritional counseling visits. Descriptive statistics were used to describe study outcomes.
All 26 patients approached to participate consented to the trial before HPB surgery. Seven were excluded after consent for failing to meet eligibility criteria (e.g., did not receive surgery). Nineteen participants (52.6% female, median age = 65 years) remained eligible for remote monitoring post-surgery. Nineteen used the mobile app food diary, 79% of participants recorded food intake for greater than 80% of study days, 95% met with the dietitian for all visits, and 89% were highly satisfied with the intervention. Among participants with complete data, the average percent caloric goal obtained was 82.4% (IQR: 21.7).
This intervention was feasible and acceptable to patients undergoing HPB surgery. Preliminary efficacy data showed most participants were able to meet calorie intake goals. Future studies should examine intervention efficacy in a larger, randomized controlled trial.
Clinicaltrials.gov. Registered 16 September 2019, https://clinicaltrials.gov/ct2/show/NCT04091165 .
接受肝胰胆(HPB)手术的患者,如患有胰腺癌、壶腹周围癌和肝癌的患者,存在营养不良的高风险。营养不良会增加手术并发症并降低总体生存率。尽管其严重性,但针对HPB手术后营养不良的干预措施有限。这项试点试验的目的是检验HPB手术后远程营养监测干预措施的可行性、可接受性、可用性和初步疗效。
参与者在出院后2周和4周时在手术前后接受了量身定制的营养咨询。参与者还连续30天每天记录营养摄入量,注册营养师在营养咨询就诊前对这些数据进行远程审查。描述性统计用于描述研究结果。
所有26名被邀请参与的患者在HPB手术前均同意参加试验。7名患者在同意后因不符合入选标准(如未接受手术)而被排除。19名参与者(52.6%为女性,中位年龄=65岁)在手术后仍符合远程监测条件。19名参与者使用了移动应用程序食物日记,79%的参与者在超过80%的研究天数中记录了食物摄入量,95%的参与者参加了所有就诊时的营养师会诊,89%的参与者对该干预措施高度满意。在有完整数据的参与者中,获得的平均热量目标百分比为82.4%(四分位间距:21.7)。
该干预措施对接受HPB手术的患者是可行且可接受的。初步疗效数据显示,大多数参与者能够达到热量摄入目标。未来的研究应在更大规模的随机对照试验中检验干预效果。
Clinicaltrials.gov。于2019年9月16日注册,https://clinicaltrials.gov/ct2/show/NCT04091165 。