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

NCT05789459 | Completed

• 1 other identifier: DP-POPF
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Pancreatectomy; Postoperative Pancreatic Fistula

Outcome Measures

Primary Outcomes (1)

• Postoperative pancreatic fistula (POPF)

  The outcome was POPF per the International Study Group of Pancreatic Surgery definition

  Within 3 months after pancreatic surgery

Secondary Outcomes (4)

• delayed gastric emptying (DGE)

  Within 3 months after pancreatic surgery

• postpancreatectomy hemorrhage (PPH)

  Within 3 months after pancreatic surgery

• Chyle leak

  Within 3 months after pancreatic surgery

• Surgical complications

  Within 3 months after pancreatic surgery

Study Arms (2)

Stapler group

closure with a stapler

Device: Stapler

Hand-sewn group

closure with suture

Other: Suture

Interventions

Stapler DEVICE

Stapler

Stapler group

Suture OTHER

Suture

Hand-sewn group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent MDP in our institution between July 2018 and June 2021.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Interventions

Surgical Staplers; Sutures

Intervention Hierarchy (Ancestors)

Surgical Instruments; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Tingbo Liang

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: July 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

CN (1)