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

Completed

• Conditions: Distal Pancreatectomy; Postoperative Pancreatic Fistula
• Interventions: Other: Suture; Device: Stapler

• Registration Number: NCT05789459
• Lead Sponsor: Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2023-03
• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-03-16
• Last Update Submitted: 2023-03-16
• Study First Posted: 2023-03-29
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 384

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hand-sewn group	Suture	closure with suture
Stapler group	Stapler	closure with a stapler

Primary Outcome Measures

Name	Time	Method
Postoperative pancreatic fistula (POPF)	Within 3 months after pancreatic surgery	The outcome was POPF per the International Study Group of Pancreatic Surgery definition

Secondary Outcome Measures

Name	Time	Method
delayed gastric emptying (DGE)	Within 3 months after pancreatic surgery	identified and graded according to the ISGPS criteria
Chyle leak	Within 3 months after pancreatic surgery	identified and graded according to the ISGPS criteria
postpancreatectomy hemorrhage (PPH)	Within 3 months after pancreatic surgery	identified and graded according to the ISGPS criteria
Surgical complications	Within 3 months after pancreatic surgery	classified according to the Clavien-Dindo system

Trial Locations

Locations (1)

the First Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China