Pancreas Neoplasm
Conditions
Brief summary
Compare open and laparoscopic assisted pancreaticoduodenectomy regarding intraoprative blood loss, organ injury, completion of planned laparoscopic steps, duration and early post operative course of pain, hem stability, oral feeding, leakage(pancreatic, billary and intestinal). ,bleeding, mortality, lymph nodes and safety margins .
Detailed description
Pancreaticoduodenectomy is the only option curative intended in the treatment of resectable pancreatic ductal adenocarcinomas, duodenal carcinoma, ampullary carcinoma, lower common bile duct cholangiocarcinoma,. It is still associated with very high morbidity and mortality. \[1\]. Pancreatic cancer ranks as the seventh leading cause of cancer-related death worldwide, and the fourth among other cancers\[2,3\]. In recent years, the minimally invasive techniques has considered revolution in surgeries of pancreatic cancers \[4,5\]. Laparoscopic assisted pancreaticoduodenectomy is a hybrid procedure combining laparoscopic resection and reconstruction through a small incision.it companies laparoscopic mobilization and dissection due to magnification compared with open pancreaticoduodenectomy\[6\]. Several studies have shown that laparoscopic assisted pancreaticoduodenectomy could result in less blood loss less, pain ,less wound infection and shorter hospital stay compared to open pancreaticoduodenectomy\[7,8\]. Limited literature described the safety and efficacy of laparoscopic assisted pancraticododenostomy .Also such comparative studies deficient in evaluation of outcomes of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.So the interest of our study is to compare between the feasibility and safety of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.
Interventions
PROCEDURElaparoscopic assisted pancreaticoduodenectomy
laparoscopic assisted pancreaticoduodenectomy.
PROCEDUREOpen pancreaticduodenctomy
Open pancreaticduodenctomy
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. age less than 70 years. 2. resectable tumour, 3. fit for surgery
Exclusion criteria
1. patients with jaundice with serum bilirubin above 200mml/dl. 2. patients with bleeding tendency until corrected. 3. patients with advanced and metastatic malignancy. 4. patients with cardiopulmonary diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post operative pain. | Compare the post operative pain between open and laparoscopic assisted pancreaticoduodenctomy in the first week after operation | Compare the post operative pain betweenopen and laparoscopic assisted pancreaticoduodenectomy |
| Blood loss | Compare the intra operative blood loss between open and laparoscopic assisted pancreaticoduodenectomy during the operation | Compare between the intra operative blood loss in the open and laparoscopic assisted pancreaticoduodenectomy |
| Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal). | Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) in the first month after operation | Compare the rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) between the open and laparoscopic assisted pancreaticoduodenctomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative haemorrhage | In the first 2 weeks | Compare between the postoperative haemorrhage by cc in the open and laparoscopic assisted pancreaticoduodenectomy |
| Postoperative 30 days mortality rate. | In the first 30days after operation | Compare between the Postoperative 30 days mortality rate in the open and laparoscopic assisted pancreaticoduodenectomy |
| Postoperative wound infection. | In the first 2 weeks | Compare between the postoperative wound infection in the open and laparoscopic assisted pancreaticoduodenectomy |
| Starting oral feeding | In the first 3 days after operation | Compare between starting oral feeding in the open and laparoscopic assisted pancreaticoduodenectomy |
Contacts
Primary Contactmohammed aly ahmed, Assist.lecturer
Backup ContactMostafa Mahmoud Mohammed Sayed, Assist.prof
Outcome results
None listed