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

NCT ID: NCT04960267

Last Updated: 2021-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-11-01

Brief Summary

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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

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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.

Conditions

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Hernia, Inguinal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Use of pre-peritoneal drainage after rTAPP

Intervention Type DEVICE

Use of pre-peritoneal drainage after rTAPP

Interventions

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Use of pre-peritoneal drainage after rTAPP

Use of pre-peritoneal drainage after rTAPP

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Joe King-Man Fan

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joe KM FAN, MBBS MS

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong-Shenzhen Hospital

Locations

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Department of Surgery, The University of Hong Kong - Shenzhen Hospital

Shenzhen, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Joe KM FAN, MBBS MS(HKU)

Role: CONTACT

+86-86913388

Facility Contacts

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Joe KM Fan, MBBS,MS,FRCS

Role: primary

+86-18307555114

References

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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.

Reference Type BACKGROUND
PMID: 29332240 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29681017 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29681018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25238803 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27889845 (View on PubMed)

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.

Reference Type RESULT
PMID: 32072340 (View on PubMed)

Other Identifiers

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HERN-rTAPPDRAIN-01

Identifier Type: -

Identifier Source: org_study_id

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