Comparison of Outcomes With Stapler Versus Hand-Sewn Clos... | NCT05789459

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

NCT05789459

Sponsor

Zhejiang University

Status

Completed

Last Update Posted

Mar 29, 2023Actual

Enrollment

384Actual

Phase

Not provided

Conditions

Distal Pancreatectomy
Postoperative Pancreatic Fistula

Interventions

Stapler
Suture

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2018Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Jun 30, 2021Actual

First Submitted Date

Mar 16, 2023

First Submission Date that Met QC Criteria

Mar 16, 2023

First Posted Date

Mar 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2023

Last Update Posted Date

Mar 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

384Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stapler group		closure with a stapler	Device: Stapler
Hand-sewn group		closure with suture	Other: Suture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stapler	Device	Stapler	Stapler group
Suture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
delayed gastric emptying (DGE)	identified and graded according to the ISGPS criteria	Within 3 months after pancreatic surgery
postpancreatectomy hemorrhage (PPH)	identified and graded according to the ISGPS criteria

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tingbo Liang	Zhejiang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the First Affiliated Hospital, School of Medicine, Zhejiang University		Hangzhou	Zhejiang	310003	China

Intervention Browse Module

MeSH Terms

ID	Term
D013528	Surgical Staplers
D013537	Sutures

Ancestor Terms

ID	Term
D013525	Surgical Instruments
D013523	Surgical Equipment
D004864	Equipment and Supplies
D053831	Surgical Fixation Devices

Browse Leaves

Not provided

Browse Branches

Not provided