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

NCT04960267 | Unknown DMC

• 1 other identifier: HERN-rTAPPDRAIN-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Inguinal

Keywords

hernia; inguinal; seroma; drain; robotic; TAPP; rTAPP

Outcome Measures

Primary Outcomes (1)

• Pre-peritoneal Drainage output after rTAPP

  Pre-peritoneal Drainage output (ml) after rTAPP

  at 23 hours post-operation

Secondary Outcomes (1)

• Seroma formation

  day 7, 1 month

Study Arms (1)

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

Use of pre-peritoneal drainage after rTAPP DEVICE

Use of pre-peritoneal drainage after rTAPP

Use of pre-peritoneal drainage after rTAPP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral,
• First occurrence
• Reducible inguinal hernia

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

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

Shenzhen, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 29332240 BACKGROUND

• 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.

  PMID: 29681017 BACKGROUND

• 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.

  PMID: 29681018 BACKGROUND

• 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.

  PMID: 25238803 BACKGROUND

• 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.

  PMID: 27889845 BACKGROUND

• 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.

  PMID: 32072340 RESULT

MeSH Terms

Conditions

Hernia, Inguinal; Hernia; Seroma

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Inflammation; Pathologic Processes

Study Officials

• Joe KM FAN, MBBS MS

  The University of Hong Kong-Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joe KM FAN, MBBS MS(HKU)

CONTACT

+86-86913388; drjoefan@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: 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 Record Dates

• First Submitted: June 10, 2021
• First Posted: July 13, 2021
• Study Start: February 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)