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

July 11, 2021 updated by: Dr. Joe King-Man Fan, The University of Hong Kong

Use of Pre-peritoneal Drainage in rTAPP - a Comparative Study With Laparoscopic TEP

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Joe KM FAN, MBBS MS(HKU)
  • Phone Number: +86-86913388
  • Email: drjoefan@hku.hk

Study Locations

  • China
      • Shenzhen, China
        • Recruiting
        • Department of Surgery, The University of Hong Kong - Shenzhen Hospital
        • Contact:
          • Joe KM Fan, MBBS,MS,FRCS
          • Phone Number: +86-18307555114
          • Email: drjoefan@hku.hk
        • Principal Investigator:
          • JW Liu
        • Sub-Investigator:
          • XF Yang
        • Sub-Investigator:
          • KJ Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

July 11, 2021

First Posted (Actual)

July 13, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 11, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HERN-rTAPPDRAIN-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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