Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Analgesics

All Drugs and Chemicals

Pharmaceutical Solutions

Fibrinolytic Agents

Anticoagulants

Central Nervous System Depressants

Heparin

Analgesics, Opioid

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Patients planned to undergoing laparoscopic gastrectomy, following the ERAS protocols.

Patents will be managed by our hospital's critical pathways.

1. Patient's preoperative counseling \& education before surgery
2. No Bowel preparation
3. Oral Carbohydrate Solution (OCS) loading until 2hours before surgery
4. Fluid restriction \& Management by pulse contour analysis or transesophageal doppler
5. Early mobilization
6. Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD))
7. Epidural patient controlled analgesics (no opioids analgesics)
8. Postoperative Nausea Active Control
9. Thromboembolism prophylaxis by low molecular weighted heparin (LMWH)
10. Perioperative High content Oxygen therapy
11. No drain insertion
12. No Levin tube
13. Patients will be discharged at POD#4 if there's no problem.

ERAS perioperative cares

1. No Patient's preoperative counseling \& education before surgery
2. Bowel preparation
3. No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery
4. Conventional Fluid Management by clinical signs (Urine output, heart rate etc.)
5. Conventional Mobilization
6. Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD)
7. IV PCA
8. Postoperative Nausea Control if needed
9. No Thromboembolism prophylaxis
10. No or Low Content Oxygen therapy
11. Routine drain insertion
12. Levin tube insertion if needed

Conventional perioperative cares

Hyung-Ho Kim, M.D., Ph.D.

Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of reducing the surgical stress response and obtaining optimal recovery after surgery.

There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment.

However, few studies exist about the implication of ERAS programs in the laparoscopic gastrectomy.

The aim of this study was to compare the recovery rate, morbidity, and quality of life in the patients undergoing laparoscopic gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.

Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy

Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study))

1. Tolerance of diet for 24 hours A. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting
2. Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA)
3. Safe ambulation (ambulation of 600m without assistance)
4. Afebrile status without major complications (fever defined as body temperature greater than 37.5)

   * Above total 4 criteria should be satisfied for the evaluation of complete recovery.

postoperative 2hours, 6 hours, 1 days, 2 days, 3 days

European organization for research and treatment of cancer (EORTC) and gastrointestinal quality of life index (GIQLI) questionnaire on postoperative 5 days, 1 month

Seoul National University Bundang Hospital

Professor

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Surgical trainees (PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2).

Training of junior doctors

Lasse Pedersen, m.d.

Lasse L Pedersen, m.d.

Inge Bernstein, PhD, MHM

Specially educated trainers will be responsible for colonoscopy training of junior doctors. The educated trainers will have attended seminars held by Valori et al.

The following fast track colonoscopy training program for junior doctors will consist of: 1) Endoscopy simulation training and theory course 2) supervised and partly supervised lower endoscopy. 3) Directly observed practical skills according graded by MCSAT (Mayo Clinical Skills Assessment Tool) .

Initially a "train the trainers" program will begin with 3 sessions held by Valori et al. at Aalborg University Hospital. 6 Trainers are expected to be trained during the "train the trainers" program. The doctors selected for the "train the trainers" program are doctors specialized in abdominal surgery with an extensive lower GI-endoscopy experience and who is considered to have an excellent teaching ability to educate junior doctor.

The training program for junior doctors consist of the following:

* Initial 1 day endoscopy simulation and theory at Nordsim. Endoscopy simulation scores will be monitored.
* 20 days of fully supervised colonoscopies (max booking of 6 colonoscopies pr day). Trainer is always present in the endoscopy room
* MCSAT (Mayo Clinical Skills Assessment Tool) will be used to grade the trainee multiple times and planned at day 0,5,10,15 and 20. Multiple graders will be used.
* Simulator test will be held at day 0, 10 and 20 colonoscopies to validate progress and compare simulator generated measures with MCSAT. Both the AccuTouch and Symbionix simulator will be used,

Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments

Computer generated score (Simulator test performed at day 0, 10 and 20)

Computer generated score (Simulator test performed at day 0, 10 and 20)colonoscopies)

Nordsim

Aalborg University Hospital

MD, Ph.D.-student

Anesthetics

26 patients received general anesthesia combined with epidural anesthesia for surgery, and patient-controlled epidural analgesia for 2 days after surgery

27 patients received general anesthesia for surgery, and patient-controlled intravenous analgesia for 2 days after surgery

epidural anesthesia

Patients received general anesthesia for surgery

general anesthesia

The purpose of this study is to prove whether general anesthesia combined with epidural anesthesia could better maintain body balance of Th1/Th2 and Treg/Th17 compared with general anesthesia, so as to reduce the surgical stress-related immunosuppression, and to improve the prognosis.

General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer

The changes of peripheral subtype of T-helper, myeloid-derived suppressor cells(MDSCs) and cytokines

Changhong Miao

Professor, Department of Anesthesiology

Anti-Infective Agents

Anti-Bacterial Agents

Somatostatin

Ethanol

Bilirubin

* Preop usual biliary drainage
* Preop smoking and alcohol
* Preop parenteral nutrition
* Oral bowel preparation (mechanical bowel preparation )
* Preoperative fasting \> 12 hours
* Pre-anesthetic medication
* Anti-thrombotic prophylaxis
* Antimicrobial prophylaxis and skin preparation
* Intravenous analgesia : PCA
* Prevention of postoperative nausea and vomiting (PONV) (X)
* Incision : surgeon direction
* Avoiding hypothermia
* Nasogastric intubation (O)
* Postop glycemic control
* Positive fluid balance
* Perianastomotic drain removal over POD #5
* Somatostatin analogues
* Transurethral catheter removal
* Delayed gastric emptying(DGE) (+) , parenteral nutrition (+)
* Postop routine artificial nutrition (O), soft diet at POD #5
* Early and scheduled mobilization

* behavioral intervention (counselling, audit)
* dietary supplement
* procedure (preoperative and postoperative)
* drug

* Preop Counseling
* Preop biliary drainage (X) when Serum Total bilirubin \< 14.62mg/dl and cholangitis (-)
* Preop enteral nutrition
* Oral bowel preparation (mechanical bowel preparation ) (X)
* Preop fasting \< 6 hours
* Prevention of postoperative nausea and vomiting (PONV) (O)
* Nasogastric intubation (X)
* Near-zero fluid balance
* Somatostatin analogues (X)
* Postop routine artificial nutrition (X), soft diet at POD #2
* Audit
* Other items are same as conventional

ERAS perioperative management

Dae Wook Hwang, M.D.

Enhanced Recovery After Surgery (ERAS) is not the program that aim to reduce postoperative hospital stay, but the multimodal strategies that aim to attenuate the loss of, and improve the restoration of,functional capacity after surgery on evidence-based medicine. The benefits of ERAS is proved in many surgical procedures, such as upper gastrointestinal surgery and colorectal surgery. However, pancreaticoduodenectomy (PD, Whipple's operation) is still one of most complex abdominal surgery, and there is no evidence that ERAS is beneficial on PD.

This study investigate the clinical effectiveness of ERAS on PD.

* This study conduct totally 276 patients who underwent PD with borderline or malignant periampullary tumor. The patients divided into two groups. One group take conventional, experienced-based perioperative management, the other group take perioperative management based on ERAS protocol. Applied ERAS protocol is based on "Guidelines for Perioperative Care for Pancreaticoduodenectomy: Ehanced Recovery After Surgery Society Recommendations.
* The outcomes are analyzed for short-term surgical outcomes including operative factors, nutritional status, morbidity, mortality, length of stay, readmission, etc.
* Among all subjects who were randomized and started any study intervention (ERAS or standard perioperative management), the patients who underwent pancreaticoduodenectomy were included as the Full analysis set (FAS). All subjects who didn't undergo pancreaticoduodenectomy were excluded from this study.
* Besides, as all subjects who were randomized and received any study intervention were obliged to follow the study protocol and monitored for best compliance, per-protocol set or safety set were not defined differently

Two study groups (Control (conventional) group and study (intervention) group) were randomly allocated and assigned to one of two groups in parallel for the whole duration of this study.

The evaluation and judgement for morbidity (primary endpoint) / mortality (secondary endpoint) was made by Morbidity and Mortality Committee in our division. Committee members were blinded about knowledge of the interventions assigned to individual participants.

The Effect of ERAS on Pancreaticoduodenectomy

The Effect of ERAS (Enhanced Recovery After Surgery) on Pancreaticoduodenectomy

At initial status of this study, IRB was approved at limited data access only.

The incidence of operation-related morbidity

The incidence of 30 days mortality and in-hospital mortality

The nutritional status would be analyzed by the comparison of PG-SGA score, body mass index and assessment of daily oral intake at preoperative, before discharge and postoperative 2\~3months.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy	NCT01938313	Gastric Cancer	ERAS perioperat... Conventional pe...	20 Years - 80 Years	Seoul National University Bundang Hospital
Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments	NCT02425657	Harm Reduction Perforation Dur... Colorectal Canc...	Training of jun...	18 Years -	Aalborg University Hospital
Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments	NCT02425657	Harm Reduction Perforation Dur... Colorectal Canc...	Training of jun...	18 Years -	Aalborg University Hospital
General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer	NCT01978717	Colorectal Neop...	epidural anesth... general anesthe...	51 Years - 65 Years	Fudan University
Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy	NCT01938313	Gastric Cancer	ERAS perioperat... Conventional pe...	20 Years - 80 Years	Seoul National University Bundang Hospital
The Effect of ERAS on Pancreaticoduodenectomy	NCT02372331	Periampullary T...	ERAS perioperat...	18 Years - 80 Years	Asan Medical Center

Spots Global Cancer Trial Database for fast track

Every month we try and update this database with for fast track cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fast track

Every month we try and update this database with for fast track cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fast track cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.