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Comparison of Outcomes With Stapler Versus Hand-Sewn Closure After Minimally Invasive Distal Pancreatectomy

Comparison of Outcomes With Stapler Versus Hand-Sewn Closure of the Pancreatic Stump Following Minimally Invasive Distal Pancreatectomy: A Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05789459
Enrollment
384
Registered
2023-03-29
Start date
2018-07-01
Completion date
2021-06-30
Last updated
2023-03-29

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

Conditions

Distal Pancreatectomy, Postoperative Pancreatic Fistula

Brief summary

The incidence of postoperative pancreatic fistula (POPF) after Distal pancreatectomy (DP) remains high. Of the available mitigation strategies, high-quality closure of the pancreatic stump is fundamental. Researchers failed to find a decrease in the incidence of POPF after stapler closure of the pancreatic stump compared with that related to hand-sewn suture in DP. Minimally invasive DP (MDP) is becoming the first choice for patients and surgeons, few studies have evaluated whether stapler closure is superior to hand-sewn suture for stump closure in MDP. Therefore, this retrospective study was aimed at evaluating the effect of stapler versus hand-sewn closure on the incidence of POPF after MDP.

Interventions

DEVICEStapler

Stapler

OTHERSuture

Suture

Sponsors

Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Underwent elective minimally invasive pancreatic body and tail resection with or without splenectomy

Exclusion criteria

* Incomplete medical records * History of previous pancreatic operations * Emergent operation * Conversion to open pancreatectomy * Receipt of wedge resection or other procedures

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pancreatic fistula (POPF)Within 3 months after pancreatic surgeryThe outcome was POPF per the International Study Group of Pancreatic Surgery definition

Secondary

MeasureTime frameDescription
delayed gastric emptying (DGE)Within 3 months after pancreatic surgeryidentified and graded according to the ISGPS criteria
postpancreatectomy hemorrhage (PPH)Within 3 months after pancreatic surgeryidentified and graded according to the ISGPS criteria
Chyle leakWithin 3 months after pancreatic surgeryidentified and graded according to the ISGPS criteria
Surgical complicationsWithin 3 months after pancreatic surgeryclassified according to the Clavien-Dindo system

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026