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

Not Applicable

• Conditions: Hernia, Inguinal
• Interventions: Device: Use of pre-peritoneal drainage after rTAPP

• Registration Number: NCT04960267
• Lead Sponsor: The University of Hong Kong

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-06-10
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-11
• Last Update Submitted: 2021-07-11
• Study First Posted: 2021-07-13
• Last Update Posted: 2021-07-13
• Primary Completion: 2021-09-01
• Study Completion: 2021-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Unilateral,
• First occurrence
• Reducible inguinal hernia

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of pre-peritoneal drainage after rTAPP	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

Primary Outcome Measures

Name	Time	Method
Pre-peritoneal Drainage output after rTAPP	at 23 hours post-operation	Pre-peritoneal Drainage output (ml) after rTAPP

Secondary Outcome Measures

Name	Time	Method
Seroma formation	day 7, 1 month	Clinical detectable seroma and size of seroma detected by USG after rTAPP with pre-peritoneal drainage

Trial Locations

Locations (1)

Department of Surgery, The University of Hong Kong - Shenzhen Hospital; 🇨🇳 Shenzhen, China