Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Stomach Cancer

Early oral feeding starting with liquids on postoperative day (POD) 1, followed by a soft diet on POD 2, and solid foods on day 3

Delayed oral feeding starting with liquids on postoperative day (POD) 4, followed by a soft diet on POD 5, and solid foods on day 6

Oral fluids starting on POD 1, followed by a soft diet (thin purée six times a day) on day 2, and regular solid diet thereafter

Early oral feeding

Marek Sierzega, MD, PhD

Jan Kulig, Prof.

Piotr Kolodziejczyk, Prof.

Ryszard Choruz, MD

Jan Kulig, prof.

The aim of this study is to evaluate the possibility of shortening postoperative hospital stay after gastrectomy by early oral feeding as a component of an enhanced recovery protocol (ERAS).

Early Oral Feeding After Total Gastrectomy for Cancer

A Randomized Clinical Trial of Early Oral Feeding as a Component of Accelerated Recovery Protocol After Total Gastrectomy for Cancer

Hospital readmissions within 30 days after discharge

Time to reach oral feeding covering 75% of patient's requirements

Quality of life measured by EORTC QLQ-C30 and EORTC QLQ - STO22

Laboratory tests, including lymphocyte count, blood albumin, blood prealbumin

Time between surgery and patient discharge

Any complication occurring during hospital stay

Jagiellonian University

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Patients who enroll in this arm are supplied a liquid diet one day before surgery without bowel preparation.

After gastric cancer surgery, they start sips of water on postoperative first day, and they are discharged once they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination.

The patients are started on sips of water on the first postoperative day. If they are tolerable, a liquid diet is started on the second postoperative day, and a soft diet on a third postoperative day for them. We have a plan to discharge the patients on the fourth postoperative day if they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination.

Early recovery

Hoon Hur, Prof.

Hoon Hur, prof.

Sang-Uk Han, prof.

Sang-Uk Han, Professor

Cheul Soo Byun, Instructor

Study preparation

* To progress this prospective study, the investigators analyzed the retrospective data of 426 patients who had been managed with conventional critical pathway after gastric cancer surgery during last 1 year.
* Through this retrospective analysis, we decided the inclusion criteria which showed significantly the lower complication rate and shorter hospital stay.

Method for Prospective study

* Patients who enroll in this prospective study are administered and are supplied a liquid diet one day before surgery without bowel preparation.
* After gastric cancer surgery, they start sips of water on postoperative first day, and they are discharged once they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination.

Enrollment of patients

* Before the patients are enrolled in this study, they give us informed consents.
* A liquid diet is supplied beginning from the morning of the day prior to operation to the midnight.

Operation and postoperative management

* All procedures are approached by laparoscopic surgery, and partial gastrectomy with lymph node dissection are performed.
* The patients who are considered to be difficult to progress early oral feeding in surgical field are excluded from the study.
* Nasogastric tube is not applied to patients.
* Postoperative pain is managed by non-opioid pain killer.
* The patients are started on sips of water on the first postoperative day.
* If they are tolerable, a liquid diet is started on the second postoperative day, and a soft diet on a third postoperative day for them.
* We have a plan to discharge the patients on the fourth postoperative day if they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination.

Evaluation of patients

- The patients are followed up to 30 days after discharge from hospital, and we check whether they are tolerable without any compliant and are readmitted.

Early Recovery After Gastric Cancer Surgery

Prospective Clinical Study for Early Recovery After Gastric Cancer Surgery

It is defined as the proportion of dropped patients from 4 days critical pathway

It is defined as the change of pain scale after surgery

It is defined the complications after surgery

It will defined as the death case during 30 days after surgery

It is defined as the time to first flatus and recovery of bowel activity after surgery

JW Pharmaceutical

Ajou University School of Medicine

Assistant Professor

Conventional feeding : They begin ingesting sips of water on third postoperative day and continued with a liquid diet for the next two days. Patients were given a soft diet on sixth postoperative day.

Early oral feeding : The patients begin ingesting sips of water on the first postoperative day. If they are tolerable, they continued with a clear liquid diet the next day and a soft diet on the third post operative day.

Procedure of Conventional feeding group: Patients are supplied water on day 3 after operation, liquid diet on day 4 and 5 and soft diet on 6 day.

Conventional feeding

Procedure of Early oral feeding group: Patients are supplied water on day 1 after operation, liquid diet on day 2 and soft diet on day 3 day.

Hae Myung Jeon, MD

Hoon Hur, MD

The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery.

Most patients who undergo gastric resection for gastric cancer have maintained going on a fast of over three days after operation. Surgeons have believed that early oral feeding might worsen patients' condition by prolonged postoperative ileus. Therefore, patients received nothing by oral route until resolution of the ileus. However, the current trend toward minimal operative injury and early discharge from hospital. In addition, development of operative technique and instrument make the operation time to be short and the patients to be fast recovery, and thus it is possible to feed early in less than two days after operation. The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery.

We collect fifty-eight patients for this study and divide into two groups using randomization method. In the early feeding group, patients will receive the liquid diet two day after operation followed by soft diet postoperative three day. Meanwhile, the patients who categorized into control group will start the liquid diet postoperative four day followed by soft diet postoperative six day. We evaluate the morbidity or mortality rate and laboratory findings. Of course, it is supposed to be same in amount of fluid and calories between two groups.

Effects of Early Oral Feeding After Resection of Gastric Cancer

Phase III Clinical Trial for Effect Early Oral Feeding on Recovery After Resection of Gastric Cancer

We measure the length of hospital stay after operation

We measure the days of flatus within 30 days after operation

We measure total cost from admission to discharge after operation

We observe the occurrence of morbidity after operation

The Catholic University of Korea

Ileus

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Lidocaine

Ketorolac

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Lidocaine 1mg/kg(loading dose, just before skin incision) and lidocaine(in normal saline, total 240cc) 1mg/kg/hr with ketorolac 90mg for 24hrs.

Normal saline 5cc(loading dose, just before skin incision) and normal saline 240cc with ketorolac 90mg for 24hrs.

Normal saline

Hyung Ook Kim, M.D

The purpose of this study is to determine whether intravenous lidocaine increase the tolerability of early oral feeding after laparoscopic colorectal surgery in patients with colorectal cancer.

* Degree of nausea/vomiting.
* Degree of postoperative pain and opioids requirement.
* Time to first flatus, time to first stool, time to tolerance of regular diet, rate of postoperative complications and duration of postoperative hospital stay.

Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery

Prospective Randomized Controlled Study for the Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery in Patients With Colorectal Cancer

Intolerance to early postoperative oral feeding is defined as the patient's having either nausea or vomiting, requiring that the patient be non-per oral status.

Kangbuk Samsung Hospital

Assistant professor

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

In this goup patients with esophagectomy are encouraged to begin the oral intake carefully and adjust according to tolerance on post operative day 1.

In delayed oral feeding group the patients receive isotonic saline by the nasoenteral feeding tube at 20 mL/h until the morning of post operative day1. Nutrition was then commenced at 20 mL/h. The rate was increased by 20 mL/h each day if tolerated, up to 80 mL/h.Esophagography was performed on postoperative day 7. Sip of water were allowed after confirming the absence of anastomosis leakage, and a full liquid diet was implemented on the following day and enteral infusion halted.

In the early oral feeding group, the patients are encouraged to intake liquid food on post operative day 1.

early oral feeding

Yin Li

The purpose of this study is to determine the feasibility of early oral food intake postoperatively in patients with thoracolaparoscopic esophagectomy. More and more evidence confirmed the role of early early enteral nutrition (NE) after esophagectomy in patients with esophageal cancer. Although enteral catheter feeding has been shown to be beneficial in patients with esophagectomy, the preference for this modality also rests on the traditional but undocumented reluctance to allow food at will. These assumed hazards of allowing normal food in the immediate postoperative period have not been scientifically tested and should be viewed against both the benefits and side effects of any artificial feeding modality. Whether early oral feeding after esophagectomy affects the incidence of life-threatening surgical complications, shortens the recovery time of bowel function and the postoperative hospital stay, improves postoperative quality of life in comparison with artificial feeding modality remains unclear. The investigators compared a routine of allowing liquid food at will from the first day after surgery with a routine of nil-by-mouth and enteral nutrition for the first 7 postoperative days. The main endpoint is the incidence rate of complications.

The literature concludes that patients should be allowed food without delay (at will) after colorectal surgery and that the customary withholding of oral intake (nil-by-mouth) for the first postoperative days is unnecessary. Robust data also suggest that the investigators should avoid the nil-by-mouth regimen after major gynecologic, urologic, and vascular surgery. The safety of early oral feeding after esophagectomy has not been investigated previously.In 2008, the results of a randomized multicenter clinical trial investigating whether a routine of allowing normal food at will immediately increases morbidity after major upper gastrointestinal surgery showed that allowing patients to eat normal food at will from the first day after major upper gastrointestinal surgery does not increase morbidity compared with traditional care with nil-by-mouth and enteral feeding. The assumed hazards of allowing oral food intake in the immediate postoperative period in patients with esophagectomy have not been scientifically tested and should be viewed against both the benefits and side effects of any artificial feeding modality.

This is a randomized study investigating the role of early oral feeding in patients with esophagectomy.In the early oral feeding group nasogastric tube is not placed routinely and patients are encouraged to intake liquid food on postoperative day 1 (POD1). In delayed oral feeding group the patients receive isotonic saline by the nasoenteral feeding tube at 20 mL/h until the morning of POD 1. Nutrition was then commenced at 20 mL/h. The rate was increased by 20 mL/h each day if tolerated, up to 80 mL/h. Esophagography is performed on postoperative day 7. Sip of water were allowed after confirming the absence of anastomotic leakage, and a full liquid diet was implemented on the following day and enteral infusion halted. The complications defined in previous study and bowel function and recovery were recorded carefully. The primary end point of this study is the postoperative complications and the secondary end points are quality of life,bowel function recovery time and length of postoperative stay between the two groups. The investigators estimated the minimum rate of patients with complications in control group population at 23%. An increase of this to 36% was considered clinically important. Detecting a difference of this magnitude or greater at a level of statistical significance of 0.05 and a power of 0.90 with a one-tailed test of proportions required a total of 130 patients in each group.Considering the rate of drop-out a total of 280 patients will be enrolled in this study.

Early Oral Feeding Following Thoracolaparoscopic Oesophagectomy in Patients With Esophageal Cancer

Early Oral Feeding Following Thoracolaparoscopic Oesophagectomy in Patients With Esophageal Cancer: a Randomized Clinical Trial

postoperative complications are graded according to Clavin-Dindo grading system

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Oral Feeding After Total Gastrectomy for Cancer	NCT01962519	Adenocarcinoma ...	Early oral feed...	18 Years - 80 Years	Jagiellonian University
Early Recovery After Gastric Cancer Surgery	NCT01642953	Fasting Malignant Neopl...	Early recovery	- 65 Years	Ajou University School of Medicine
Effects of Early Oral Feeding After Resection of Gastric Cancer	NCT00606619	Gastric Cancer	Conventional fe... Early oral feed...	20 Years - 75 Years	The Catholic University of Korea
Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery	NCT01346917	Colorectal Canc...	Lidocaine Normal saline	18 Years -	Kangbuk Samsung Hospital
Early Oral Feeding Following Thoracolaparoscopic Oesophagectomy in Patients With Esophageal Cancer	NCT01998230	Esophageal Canc...	early oral feed...	18 Years - 80 Years	Henan Cancer Hospital
Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery	NCT01346917	Colorectal Canc...	Lidocaine Normal saline	18 Years -	Kangbuk Samsung Hospital

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