Robotic-assisted middle pancreatectomy versus open middle pancreatectomy in patients with benign or borderline tumor of pancreatic neck and body: A randomized controlled trial

Short-term efficacy of robotic-assisted middle pancreatectomy versus open middle pancreatectomy in patients with benign or borderline tumor of pancreatic neck and body: A randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000882628

Enrollment

100

Registered

2014-08-20

Start date

2011-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Robot-assisted laparoscopic middle pancreatectomy (RLMP) is a novel minimally invasive surgery technique. None of prospective RCT comparing RLMP and Open middle pancreatectomy (OMP) have been presented.This study aimed to prospectively evaluate the effectiveness and advancement of RLMP versus OMP.

Interventions

Robotic-assisted middle pancreatectomy Robot-assisted laparoscopy is the most advanced minimally invasive surgery technique characteristic of a magnified three-dimensional visualization and endowrist instruments with greater range of motion.Middle Pancreatectomy (MP) is a major surgical operation for borderline or benign tumor of pancreatic neck and body. Approximate duration required to complete robotic-assisted MP is about 200minutes.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

(1) a tumor in the middle pancreas that was at least 5 cm from the pancreatic tail and might involve the pancreatic duct; (2) a tumor size less than 10 cm; (3) a benign or borderline tumor, such as an endocrine tumor, a serous or mucinous adenoma, a noninvasive intraductal papillary tumor (IPMTs) or a solid-pseudopapillary tumor (SPTs); and (4) pancreatic cystic tumors (lymphoepithelial cysts, dermoid cysts and hydatid cysts) that would be difficult to excise locally.

Exclusion criteria

(1) had severe underlying cardiopulmonary disease with poor heart and lung function, (2) could not tolerate anesthesia, (3) had a previous history of abdominal surgery that had resulted in severe abdominal adhesions, (4) scheduled for surgical treatment other than middle pancreatectomy such as distal pancreatectomy, (5) refusal to participate in or withdrawing from this study

Outcome results