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

Hernia, Inguinal Clinical Trial

— DrainrTAPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04960267
• Other study ID #: HERN-rTAPPDRAIN-01
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: July 2021
• Source: The University of Hong Kong
• Contact: Joe KM FAN, MBBS MS(HKU)
• Phone: +86-86913388
• Email: drjoefan[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Device:
• Use of pre-peritoneal drainage after rTAPP
Use of pre-peritoneal drainage after rTAPP

Locations

Country	Name	City	State
China	Department of Surgery, The University of Hong Kong - Shenzhen Hospital	Shenzhen

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-peritoneal Drainage output after rTAPP	Pre-peritoneal Drainage output (ml) after rTAPP	at 23 hours post-operation
Secondary	Seroma formation	Clinical detectable seroma and size of seroma detected by USG after rTAPP with pre-peritoneal drainage	day 7, 1 month