Use of Pre-peritoneal Drainage in rTAPP - a Comparative S... | NCT04960267

Studies
Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study

NCT04960267

Sponsor

The University of Hong Kong

Status

Unknown status

Last Update Posted

Jul 13, 2021Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Hernia, Inguinal

Interventions

Use of pre-peritoneal drainage after rTAPP

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

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

Sep 1, 2021Estimated

Completion Date

Nov 1, 2021Estimated

First Submitted Date

Jun 10, 2021

First Submission Date that Met QC Criteria

Jul 11, 2021

First Posted Date

Jul 13, 2021Actual

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

Jul 11, 2021

Last Update Posted Date

Jul 13, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Joe King-Man Fan, Consultant, The University of Hong KongPrincipal Investigator

Lead Sponsor

The University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The safety and efficacy of pre-peritoneal drain after TEP has been validated in our previous studies - which can effectively reduce seroma formation post-operatively and safe in clinical use. We shall extend the indication of pre-peritoneal drainage after robotic TAPP, results will be compared with our retrospective cohort from previous studies.

Detailed Description

Criteria of enrolling into trial is same as our previous experiment: aged 18-80, unilateral, first occurrence, reducible, non-inguino-scrotal inguinal hernia fit for GA for minimally invasive hernia repair. Routine robotic TAPP performed in standardized manner and pre-peritoneal drains are placed for drainage of 23 hours post-operatively. Drain output, pain scores, status of seroma formation (clinical, USG detected), post-operative recovery and recurrence will be monitored and compared.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Use of pre-peritoneal drainage after rTAPP	Experimental	Use of pre-peritoneal drainage after rTAPP Outcomes will be compared with retrospective cohort from our previous experiments	Device: Use of pre-peritoneal drainage after rTAPP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Use of pre-peritoneal drainage after rTAPP	Device	Use of pre-peritoneal drainage after rTAPP	Use of pre-peritoneal drainage after rTAPP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pre-peritoneal Drainage output after rTAPP	Pre-peritoneal Drainage output (ml) after rTAPP	at 23 hours post-operation

Secondary Outcomes

Measure	Description	Time Frame
Seroma formation	Clinical detectable seroma and size of seroma detected by USG after rTAPP with pre-peritoneal drainage	day 7, 1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unilateral,
First occurrence
Reducible inguinal hernia

Exclusion Criteria:

Not fit for GA,
Bilateral hernia
Recurrent hernia
Irreducible hernia
Inguino-scrotal extension hernia
Non-inguinal hernia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joe KM FAN, MBBS MS(HKU)	Contact	+86-86913388		drjoefan@hku.hk

Overall Officials

Name	Affiliation	Role
Joe KM FAN, MBBS MS	The University of Hong Kong-Shenzhen Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery, The University of Hong Kong - Shenzhen Hospital	Recruiting	Shenzhen			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29332240	Background	Fan JKM, Liu J, Chen K, Yang X, Xu X, Choi HK, Chan FSY, Chiu KWH, Lo CM. Preperitoneal closed-system suction drainage after totally extraperitoneal hernioplasty in the prevention of early seroma formation: a prospective double-blind randomised controlled trial. Hernia. 2018 Jun;22(3):455-465. doi: 10.1007/s10029-018-1731-2. Epub 2018 Jan 13.
29681017

ID	Term
D046449	Hernia, Abdominal
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D007249	Inflammation

ID	Term
D006552	Hernia, Inguinal
D006547	Hernia
D049291	Seroma