To study the efficacy of sham feeding using chewing gum in reducing the duration of post operative ileus following gastrointestinal surgeries A randomised control study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The primary outcome is time to first passage of flatus.
研究概览
简要总结
Post operative ileus is the temporrary inhibition of gastro intestinal motility due to non mechanical causes.Occuring after abdominal surgeries,particularly after handling the bowel,it may resultin nausea,vomitting and anorexia.Itssequel include malnutrition,dehydration,electrolyte imbalance and aspiration pneumonia.Post operative ileus poses a significant socio economic impact by prolonging hospital stay by as much as 5 days per patient. Chewing gum ,alongside other multipronged approaches recognised by Enhanced recovery after surgery (ERAS) society, is thought to stimualte sham feeding which may stimulate gastrointestinal recovery post opertaively by the activation of cephalic-vagal axis.Additionally , many practitioners are reluctant to institute early feeding in some cases due to fears over safety and potential complications.Sham feeding could therefore be considered a safer alternative to early enteral nutrition in reducing post operative ileus.The aim of this study is to compare the efficacy of sham feeding using chewing to standard conventional care in the management of post operative illness in adults undergoing gastrointestinal surgeries.Participants who met exclusion and inclusion criteria were stratified into two strata emergency and elective gastrointestinal surgeries and simple randomisation is performed and participants were allocated into chewing and non chewing group.The interventional group(chewing group) receieved sham feeding using chewing gum (wrigleys sugar free chewing gum - spearmint flavor,5 calories) 6 hours after surgery three times a days each time for 15 minutes until time to passage of first flatus and the other group non chewing group receieved standard conventional management of postoperative ileus.All patients will receive same post operative feeding regimen based on ausculatatory bowel sounds sips of water will started and diet will be started as tolerated.The primary outcome of study is time to first passage of flatus.secondary outcomes are time to first ausculattory bowel sounds,time of tolerating normal diet,time to first passage of stools,duration and course of hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of age more than 18 years and less than 65 years.
- •Patient undergoing open gastrointestinal surgeries both elective and emergency.
- •Patient requiring NPO following gastrointestinal surgeries.
排除标准
- •Patient swith documented allergies to content of chewing gum.
- •Patient who will be unconscious or unable to chew gum after 24 hours post surgery.
- •Patients of age less than 18 years Patient who refuse to participate in trials.
- •Patients with defective or incomplete chewing movements and no teeth.
- •Patient undergoing laparoscopic gastrointestinal surgeries.
- •Patient undergoing bowel resection and anastomosis.
- •Patients with ongoing sepsis will not be included in the study.
- •Polytrauma patients will not be included in the study.
结局指标
主要结局
The primary outcome is time to first passage of flatus.
时间窗: The primary outcome will be assesed starting from six hours post surgery till passage of first flatus.
次要结局
- time of tolerating normal diet(will be assesed starting from six hours post surgery till time to tolerate normal diet.)
- duration & course of hospital stay.(will be assesed starting from the day of admission of patient to day of discharge.)
- time of first auscultatory bowel sounds.(first auscultatory bowel sounds will be assesed three times a day starting from six hours post surgery.)
- time to passage of first stools(will be assesed from immediate post surgery till passage of first stools.)
研究者
Dr Nirmalkumar U
Sri Manakula Vinayagar Medical college and Hospital