To assess the post-operative quality of recovery after robot-assisted as compared to open extended lateral pancreaticojejunostomy.
ID
Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: Quality of recovery as measured by the QoR-15.
Secondary outcome
Secondary: blood loss, total operative time, complications (surgical site
infection, delayed gastric emptying, postoperative pancreatic fistula,
postpancreatectomy haemorrhage), cumulative opioid consumption, all-cause
mortality, time to functional recovery, area under the curve of QoR-15 until
conditions of time to functional recovery are met, hospital stay,
readmission(s) for any indication, quality of life, costs, endoscopic
interventions, surgical interventions, new-onset endocrine pancreatic
insufficiency, new-onset exocrine pancreatic insufficiency, pain (Izbicki pain
score, COMPAT, NRS), disease progression.
Background summary
Surgery is the treatment of choice for patients with painful chronic
pancreatitis and a dilated main pancreatic duct and is typically performed via
laparotomy. However, pain control in the first days after surgery may be
problematic in these patients. For this reason, a minimally invasive
robot-assisted extended lateral pancreaticojejunostomy may improve
postoperative pain control and lead to faster post-operative recovery. However,
randomized trials validating these benefits have not been performed.
Study objective
To assess the post-operative quality of recovery after robot-assisted as
compared to open extended lateral pancreaticojejunostomy.
Study design
Multicenter randomized controlled patient- and assessor blinded trial.
Intervention
Robot-assisted extended lateral pancreaticojejunostomy
Study burden and risks
Participating patients are burdened with questionnaires during follow-up.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
1. At least 18 years old
2. Indication for extended lateral pancreaticojejunostmy as agreed during
multidisciplinary team meeting based on symptomatic CP (i.e. morphine dependent
pain or recurrent acute pancreatitis)
3. Dilated pancreatic duct of >= 5 mm, without enlarged pancreatic head < 40 mm
4. Confirmed CP, according to the M-ANNHEIM diagnostic
Criteria22
• Typical clinical history of chronic pancreatitis
(i.e. recurrent pancreatitis or abdominal pain), and:
• One or more of the following additional criteria
for the diagnosis of CP:
o Pancreatic calcifications on CT or MRI imaging.
o Moderate or marked ductal lesions (according to the Cambridge classification)
on endoscopic retrograde cholangiopancreatography (ERCP) or magnetic resonance
cholangiopancreatography (MRCP) imaging.
o Marked and persistent exocrine insufficiency (defined as: a. pancreatic
steatorrhea clearly relieved by enzyme supplementation, and/or b. fecal
elastase levels of <= 200 micro gram/gram).
5. Eligible for both a robot-assisted and open approach
6. Obtained written informed consent
Exclusion criteria
1. Suspected or confirmed current pancreatic malignancy
2. Known allergy / contraindication for epidural anesthesia
3. ASA classification >= 4
4. Other painful conditions aside from chronic pancreatitis, making it unable
differentiate between pain related to chronic pancreatitis and pain stemming
from other sources
5. Stones and strictures exclusively located in the tail of the pancreas (i.e.
to the left of the vertebra) with relatively normal pancreatic head and corpus
6. Prior pancreatic surgery
7. Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87297.018.24 |