search
Back to results

Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study (DrainrTAPP)

Primary Purpose

Hernia, Inguinal

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Use of pre-peritoneal drainage after rTAPP
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring hernia, inguinal, seroma, drain, robotic, TAPP, rTAPP

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery, The University of Hong Kong - Shenzhen HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Use of pre-peritoneal drainage after rTAPP

Arm Description

Use of pre-peritoneal drainage after rTAPP Outcomes will be compared with retrospective cohort from our previous experiments

Outcomes

Primary Outcome Measures

Pre-peritoneal Drainage output after rTAPP
Pre-peritoneal Drainage output (ml) after rTAPP

Secondary Outcome Measures

Seroma formation
Clinical detectable seroma and size of seroma detected by USG after rTAPP with pre-peritoneal drainage

Full Information

First Posted
June 10, 2021
Last Updated
July 11, 2021
Sponsor
The University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT04960267
Brief Title
Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study
Acronym
DrainrTAPP
Official Title
Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study With Laparoscopic TEP
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
hernia, inguinal, seroma, drain, robotic, TAPP, rTAPP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Use of pre-peritoneal drainage after rTAPP
Arm Type
Experimental
Arm Description
Use of pre-peritoneal drainage after rTAPP Outcomes will be compared with retrospective cohort from our previous experiments
Intervention Type
Device
Intervention Name(s)
Use of pre-peritoneal drainage after rTAPP
Intervention Description
Use of pre-peritoneal drainage after rTAPP
Primary Outcome Measure Information:
Title
Pre-peritoneal Drainage output after rTAPP
Description
Pre-peritoneal Drainage output (ml) after rTAPP
Time Frame
at 23 hours post-operation
Secondary Outcome Measure Information:
Title
Seroma formation
Description
Clinical detectable seroma and size of seroma detected by USG after rTAPP with pre-peritoneal drainage
Time Frame
day 7, 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joe KM FAN, MBBS MS(HKU)
Phone
+86-86913388
Email
drjoefan@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe KM FAN, MBBS MS
Organizational Affiliation
The University of Hong Kong-Shenzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, The University of Hong Kong - Shenzhen Hospital
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joe KM Fan, MBBS,MS,FRCS
Phone
+86-18307555114
Email
drjoefan@hku.hk
First Name & Middle Initial & Last Name & Degree
JW Liu
First Name & Middle Initial & Last Name & Degree
XF Yang
First Name & Middle Initial & Last Name & Degree
KJ Chen

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29332240
Citation
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.
Results Reference
background
PubMed Identifier
29681017
Citation
Li J, Zhang W. Comment to: Preperitoneal closed-system suction drainage after totally extraperitoneal hernioplasty in the prevention of early seroma formation: a prospective double-blind randomised controlled trial. Fan JKM, Liu J, Chen K, Yang X, Xu X, Choi HK, Chan FSY, Chiu KWH, Lo CM. Hernia. 2018 Jun;22(3):467-468. doi: 10.1007/s10029-018-1762-8. Epub 2018 Apr 21. No abstract available.
Results Reference
background
PubMed Identifier
29681018
Citation
Fan JKM, Liu J, Chen K, Yang X, Xu X, Choi HK, Chan FSY, Chiu KWH, Lo CM. Reply to Comment to: Preperitoneal closed-system suction drainage after totally extraperitoneal hernioplasty in the prevention of early seroma formation: a prospective double-blind randomized controlled trial. Hernia. 2018 Jun;22(3):469-470. doi: 10.1007/s10029-018-1764-6. Epub 2018 Apr 21. No abstract available.
Results Reference
background
PubMed Identifier
25238803
Citation
Gao D, Wei S, Zhai C, Chen J, Li M, Gu C, Wu H. Clinical research of preperitoneal drainage after endoscopic totally extraperitoneal inguinal hernia repair. Hernia. 2015 Oct;19(5):789-94. doi: 10.1007/s10029-014-1310-0. Epub 2014 Sep 20.
Results Reference
background
PubMed Identifier
27889845
Citation
Fan JKM, Yip J, Foo DCC, Lo OSH, Law WL. Randomized trial comparing self gripping semi re-absorbable mesh (PROGRIP) with polypropylene mesh in open inguinal hernioplasty: the 6 years result. Hernia. 2017 Feb;21(1):9-16. doi: 10.1007/s10029-016-1545-z. Epub 2016 Nov 26.
Results Reference
background
PubMed Identifier
32072340
Citation
Liu JW, Chen KJ, Xu XH, Deng Y, Zhang H, Chan FSY, Kim HJ, Fan JKM. Does the use of monopolar energy as the preferred mode of dissection effectively reduce seroma formation in laparoscopic total extra peritoneal hernioplasty? A prospective double-blinded randomized control trial. Hernia. 2020 Aug;24(4):821-829. doi: 10.1007/s10029-020-02136-3. Epub 2020 Feb 18.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs