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

Sponsor
The University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT04960267
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
9
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Use of pre-peritoneal drainage after rTAPP
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study With Laparoscopic TEP
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Use of pre-peritoneal drainage after rTAPP

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
Use of pre-peritoneal drainage after rTAPP

Outcome Measures

Primary Outcome Measures

  1. Pre-peritoneal Drainage output after rTAPP [at 23 hours post-operation]

    Pre-peritoneal Drainage output (ml) after rTAPP

Secondary Outcome Measures

  1. Seroma formation [day 7, 1 month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Surgery, The University of Hong Kong - Shenzhen Hospital Shenzhen China

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: Joe KM FAN, MBBS MS, The University of Hong Kong-Shenzhen Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Joe King-Man Fan, Consultant, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04960267
Other Study ID Numbers:
  • HERN-rTAPPDRAIN-01
First Posted:
Jul 13, 2021
Last Update Posted:
Jul 13, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Dr. Joe King-Man Fan, Consultant, The University of Hong Kong
hernia
inguinal
seroma
drain
robotic
TAPP
rTAPP
Additional relevant MeSH terms:
Hernia
Hernia, Inguinal

Study Results

No Results Posted as of Jul 13, 2021