The effectiveness of adding Braun anastomosis to Standard Child reconstruction to reduce delayed gastric emptying after pancreatoduodenectomy (REMBRANDT): a multicenter randomized-controlled trial.

The effectiveness of adding Braun anastomosis to Standard Child reconstruction to reduce delayed gastric emptying after pancreatoduodenectomy (REMBRANDT): a multicenter randomized-controlled trial. - REMBRANDT TRIAL

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56185

Enrollment

256

Registered

2023-02-14

Start date

2023-04-17

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

pancreas cancer pancreas head carcinoma

Interventions

Braun enteroenterostomy (BE), or Braun anastomosis, in addition to usual care.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • undergoing open pancreatoduodenectomy • provided informed consent • age over 18 years

Exclusion criteria

Exclusion criteria: • insufficient control of the Dutch language to read the patient information and to fill out the questionnaires in Dutch hospitals • insufficient control of the Italian language to read the patient information and to fill out the questionnaires in Italian hospitals • Previous bariatric surgery (such as Roux-en-Y gastric bypass, gastric sleeve) • Pregnancy • Bowel motility disorders • Minimally invasive pancreatoduodenectomy • Gastric outlet obstruction

Design outcomes

Primary

Measure	Time frame
Incidence of DGE Grade B/C (according to International Study Group of Pancreatic Surgery (ISGPS) )	—

Secondary

Measure	Time frame
Incidence of postoperative pancreatic fistulas (POPF) Grade B/C (according to ISGPS), anastomotic leak (HJ, BE), complications, hospital length of stay, functional outcome at 12 months, in-hospital mortality, 30-day mortality. Healthcare costs.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)