Postprocedural Delayed Gastric Emptying
Conditions
Keywords
delayed gastric emptying(DGE), pancreaticoduodenectomy(PD), randomized controlled trial(RCT), gastro- or duodeno- jejunostomy reconstruction, morbidity
Brief summary
The purpose of this study is to evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction.
Detailed description
The purpose of this study is to evaluate the incidence of delayed gastric emptying in patient with pancreaticoduodenectomy between antecolic and retrocolic gastrointestinal reconstruction. Delayed gastric emptying after pancreaticoduodenectomy is important to affect the postoperative course and QOL. We conducted a prospective randomized trial on 240 patients who underwent pancreaticoduodenectomy for comparing between antecolic and retrocolic gastrointestinal reconstruction. The primary endpoint was defined as incidence of delayed gastric emptying by ISGPS criteria. The secondary endpoint was defined as incidence of other postoperative morbidity. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated for pancreatic head and periampullary disease, and an appropriate informed consent was obtained. Exclusion criteria was 1) patients who have the history of gastrectomy, 2) patients who have severe cardiorespiratory dysfunction, 3) patients who have liver cirrhosis or are receiving dialysis, and 4) patients who were diagnosed inadequate for this study by a physician.
Interventions
PROCEDURERetrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy
The duodenojejunostomy or gastrojejunostomy was constructed in two layers or single layer. For the retrocolic reconstruction, the jejunal loop was anastomosed to the duodenum or stomach through a separate mesocolic window on the left of the middle colic vessels.
PROCEDUREAntecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy
The duodenojejunostomy or gastrojejunostomy was constructed in two layers or single layer. For the antecolic reconstruction, the jejunal loop about 30 cm distal to the hepaticojejunostomy, was brought up anterior to the transverse colon and anastomosed to the duodenum or stomach.
Sponsors
Kobe University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients with pancreatic-biliary disease who undergo pancreaticoduodenectomy
Exclusion criteria
* patients who have the history of gastrectomy * patients who have severe cardiorespiratory dysfunction * patients who have liver cirrhosis or are receiving dialysis * patients who were diagnosed inadequacy for this study by a physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incident rate of delayed gastric emptying | during hospital stay after surgery, an expected average of 3 weeks | DGE represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A,B,and C) were defined based on the impact on the clinical course and on postoperative management by ISGPS. |
Countries
Japan
Contacts
Primary ContactIppei Matsumoto, MD
Outcome results
None listed