Early post operative outcomes and PROM following Robotic-Assisted Pancreaticodiodenectomy RAW Laparoscopic-Assisted Pancreaticoduodenectomy LAW and Open Whipples Pancreaticoduodenectomy OWL a three arm RCT
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Dr Asuri Krishna
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Morbidity as per Clavein-Dindo Classification
Overview
Brief Summary
| Minimal Invasive surgeries have suggested to enhance post Operative recovery when compared to their Open counterparts, However, there are concerns about the extensive learning curve due to the complex nature which could increase the risk of complications. |
Pancreatoduodenectomy is the only curative treatment option for periampullary cancer, for many benign and premalignant tumors of the region . Pancreaticoduodenectomy was described by Alessandro Codivilla, an Italian surgeon, in 1898.
The primary objective of this Randomized trial study is to conduct a preliminary comparative analysis of postoperative complications and mortality between robotic-assisted whipple’s procedure, laparoscopic-assisted Whipple’s procedure and open Whipple’s pancreaticoduodenectomy. By exploring a smaller dataset of patients who will undergo either technique, we aim to provide initial insights into potential differences in outcomes.
The cost-effectiveness and quality of life associated with MIPD have currently only been reported in small observational studies. These studies reported higher operative costs of MIPD, which were compensated by lower postoperative costs because of shorter hospital stay. However, the limited sample sizes of these studies do not allow reliable conclusions. Outcomes of open pancreatoduodenectomy have also improved in recent years with enhanced recovery strategies leading to shorter postoperative hospital stay. These parameters should therefore be assessed in a multicenter randomized trial using an enhanced recovery setting for both MIPD and open pancreatoduodenectomy.
Laparoscopic assisted pancreaticoduodenectomy (LAPD), a hybrid procedure combining laparoscopic resection and reconstruction under a small incision, may serve as an alternative on the road to matured application of TLPD. The potential advantages of LAPD include more precise mobilization and dissection compared with OPD, and more precise reconstruction and hemostasis compared with TLPD, which will possibly lead to a more favorable postoperative recovery.
Almost a decade after laparoscopic Pancreaticoduodenectomy was practised, the development of innovative robotic platforms has later opened a new horizon for surgical treatment of pancreatic cancer. Robotic surgery has emerged as a potential alternative to laparoscopy, overcoming some of the intrinsic limitations of laparoscopy. In the hands of experienced surgeons, RAPD may have a modest yet statistically significant reduction in estimated blood loss, postoperative length of stay, wound complications, and delayed gastric emptying comparing to OPD in similar patients.
The purpose of the present study is to compare the postoperative outcomes of RAPD, LAPD and OPD - Postoperative complications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult patients (age 18 years or older). Surgical Obstructive Jaundice with diagnosed proven PeriAmpullary mass.
- •requiring Pancreaticoduodenectomy Benign, premalignant/malignant Pancreatic diseases requiring Pancreaticoduodenectomy.
Exclusion Criteria
- •metastatic disease Presence of unresectable tumor detected pre-operative or intra-operatively BMI more than 35 kg/m2 Patients with ongoing pancreatitis Patients with previous abdominal surgery Patients with absolute contraindications of laparoscopic surgeries Pregnancy.
Outcomes
Primary Outcomes
Morbidity as per Clavein-Dindo Classification
Time Frame: At the time of discharge, 1 month and 3 months
Secondary Outcomes
- Operative time(Intraoperative)
- Duration of hospital stay(At discharge)
- Mortality(At discharge, 1 month and 3 months)
- Wound infection rate(At discharge, 1 month and 3 months)
- Rates of clinically relevant - postoperative pancreatic fistula(post operative day 3, day 5 and At discharge)
- Conversion rate from Robotic assisted Pancreatico-duodenectomy to Open Pancreatico-duodenectomy(Intraoperative)
- Conversion rate from laparoscopic assisted Pancreatico-duodenectomy to open Pancreatico-duodenectomy(Intraoperative)
Investigators
Dr Asuri Krishna
All india institute of medical sciences, New delhi