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Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP)

Primary Purpose

Hernia, Inguinal, Laparoscopy

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Robotic TAPP
Laparoscopic TAPP
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring Adult, Robotic surgical procedures, Abdomen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ASA 1- 3 Clinical or radiologic diagnosis of inguinal hernia (unilateral, bilateral, recurrent, inguinoscrotal) Eligible for a laparoscopic procedure Informed concent Exclusion Criteria: Incarcerated inguinal hernia requiring emergency surgery Pregnancy Patients with chronic pain due to arthritis, migraine or other illness requiring regular intake of pain relieve (paracetamol, NSAID etc) Active cancer History of psychiatric or additive disorder that prevent the patient from participating in the trial Co-existing inflammatory disease Co-existing immunological disease that requires medication of any kind

Sites / Locations

  • Sygehus SoenderjyllandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic TAPP

Laparoscopic TAPP

Arm Description

Repair of primary unilateral and bilateral hernias with robotic technology

Repair of primary unilateral and bilateral hernias with laparoscopic repair

Outcomes

Primary Outcome Measures

Surgical stress response (CRP)
Change of serum CRP over time.

Secondary Outcome Measures

Estimated intraoperative blood loss
The amount of intraoperative blood loss measured in mL, estimated by the primary surgeon
Intraoperative need of blood transfusion
The amount of blood transfused during surgery measured in mL
Length of hospital stay
The number of days patients spend in the hospital following the procedure.
Hernia defect size
The area of the hernial defect in cm2 measured at 8 mmHg
Total surgical time
The procedure will be divided into 4 parts. Part 1 will be different for the 2 procedures. In rTAPP it will consist of docking of the robot and port placement while it only will consist of port placement in TAPP. Part 2 and 3 will be the same for both procedures and will consist of hernia reduction and preparation of the preperitoneal space where the mesh is placed (part 2), mesh placement and suturing of the peritoneum (part 3). Part 4 will also be different for the 2 procedures. In rTAPP it will consist of de-docking and skin closure while it only will consist of skin closure in TAPP. Total surgical time and each part will be measured individually in minutes and the 2 procedures will be compared
Postoperative complications
Classified into grades (I-V) according to the Clavien-Dindo classification
Life-quality
According to the EUropean Registry for Abdominal wall HerniaS Quality Of Life questionnaire (Eura-HS QoL). The total score ranges from 0 (best quality of life) to 90 (worst quality of life)
Sexual dysfunction
According to the Sexual Inguinal Hernia Questionnaire (SexIHQ) a 1-page, 8-question questionnaire including visual analogue scales and tick-boxes used to asses sexual dysfunction following inguinal hernia repair
Surgical stress response (IL1-β)
The change of serum IL1-β over time.
Surgical stress response (IL-6)
The change of serum IL-6 over time.
Surgical stress response (IL-8)
The change of serum IL-8 over time.
Surgical stress response (IL-10)
The change of serum IL-10 over time.
Surgical stress response (TNF-α)
The change of serum TNF-α over time.

Full Information

First Posted
February 28, 2023
Last Updated
May 1, 2023
Sponsor
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05839587
Brief Title
Transabdominal Preperitoneal Inguinal Hernia Repair
Acronym
TAPP
Official Title
Short-term Outcome and Inflammatory Stress Response Following Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP) - A Prospective, Randomized Trial Comparing Laparoscopy to the Robotic-assisted Approach
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study seeks to determine whether improved visual acuity and enhanced flexibility of the robotic platform results in a reduced surgical stress response and an improvement in indices of surgical outcome measures for simple and complex inguinal hernia repair
Detailed Description
Complex inguinal hernia repair is challenging and requires both advanced skills in laparoscopic surgery and knowledge about the complex anatomy of the inguinal area. Whereas the repair of a small inguinal hernia usually is simple and straightforward, complex hernias (large inguinoscrotal and recurrent hernias) constitute a surgical challenge due to the risk of damage of the neurovascular structures in the inguinal area. It requires advanced laparoscopic skills to reduce the hernial sac in patients with large lateral hernias, where the hernial sac often extends deep into the scrotum in close vicinity to the spermatic cord and the testicular artery. This dissection is difficult with conventional laparoscopy, which may explain the risk of chronic pain, testicular hypotrophy and hernia recurrence. The aim of the study is to determine whether rTAPP of complex inguinal hernias is associated with a lower surgical stress response and a lower risk of postoperative complications compared to laparoscopic TAPP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal, Laparoscopy
Keywords
Adult, Robotic surgical procedures, Abdomen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic TAPP
Arm Type
Experimental
Arm Description
Repair of primary unilateral and bilateral hernias with robotic technology
Arm Title
Laparoscopic TAPP
Arm Type
Active Comparator
Arm Description
Repair of primary unilateral and bilateral hernias with laparoscopic repair
Intervention Type
Procedure
Intervention Name(s)
Robotic TAPP
Intervention Description
Robotic TAPP consists of four different procedures. Part 2 and 3 will be the same for both procedures and will consist of hernia reduction and preparation of the preperitoneal space where the mesh is placed (part 2), mesh placement and suturing of the peritoneum (part 3). Part 1 consists of docking of the robot and port placement and part 4 consists of de-docking and skin closure
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic TAPP
Intervention Description
Laparoscopic TAPP consists of four different procedures. Part 2 and 3 will be the same for both procedures and will consist of hernia reduction and preparation of the preperitoneal space where the mesh is placed (part 2), mesh placement and suturing of the peritoneum (part 3). Part 1 consists of port placement only and part 4 consists of skin closure only.
Primary Outcome Measure Information:
Title
Surgical stress response (CRP)
Description
Change of serum CRP over time.
Time Frame
CRP will be measured preoperatively at baseline, 1 day postoperatively and 3 days postoperatively
Secondary Outcome Measure Information:
Title
Estimated intraoperative blood loss
Description
The amount of intraoperative blood loss measured in mL, estimated by the primary surgeon
Time Frame
intraoperative (From first incision until last suture has been placed)
Title
Intraoperative need of blood transfusion
Description
The amount of blood transfused during surgery measured in mL
Time Frame
intraoperative (From first incision until last suture has been placed)
Title
Length of hospital stay
Description
The number of days patients spend in the hospital following the procedure.
Time Frame
Up to 3 months
Title
Hernia defect size
Description
The area of the hernial defect in cm2 measured at 8 mmHg
Time Frame
During surgery
Title
Total surgical time
Description
The procedure will be divided into 4 parts. Part 1 will be different for the 2 procedures. In rTAPP it will consist of docking of the robot and port placement while it only will consist of port placement in TAPP. Part 2 and 3 will be the same for both procedures and will consist of hernia reduction and preparation of the preperitoneal space where the mesh is placed (part 2), mesh placement and suturing of the peritoneum (part 3). Part 4 will also be different for the 2 procedures. In rTAPP it will consist of de-docking and skin closure while it only will consist of skin closure in TAPP. Total surgical time and each part will be measured individually in minutes and the 2 procedures will be compared
Time Frame
During surgery
Title
Postoperative complications
Description
Classified into grades (I-V) according to the Clavien-Dindo classification
Time Frame
From surgery until 6 months postoperatively
Title
Life-quality
Description
According to the EUropean Registry for Abdominal wall HerniaS Quality Of Life questionnaire (Eura-HS QoL). The total score ranges from 0 (best quality of life) to 90 (worst quality of life)
Time Frame
From inclusion until 6 months postoperatively
Title
Sexual dysfunction
Description
According to the Sexual Inguinal Hernia Questionnaire (SexIHQ) a 1-page, 8-question questionnaire including visual analogue scales and tick-boxes used to asses sexual dysfunction following inguinal hernia repair
Time Frame
From inclusion until 6 months postoperatively
Title
Surgical stress response (IL1-β)
Description
The change of serum IL1-β over time.
Time Frame
IL1-β will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
Title
Surgical stress response (IL-6)
Description
The change of serum IL-6 over time.
Time Frame
IL-6 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
Title
Surgical stress response (IL-8)
Description
The change of serum IL-8 over time.
Time Frame
IL-8 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
Title
Surgical stress response (IL-10)
Description
The change of serum IL-10 over time.
Time Frame
IL-10 will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation
Title
Surgical stress response (TNF-α)
Description
The change of serum TNF-α over time.
Time Frame
TNF-α will be measured preoperatively at baseline, 30 minutes after extubation and 120 minutes after extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA 1- 3 Clinical or radiologic diagnosis of inguinal hernia (unilateral, bilateral, recurrent, inguinoscrotal) Eligible for a laparoscopic procedure Informed concent Exclusion Criteria: Incarcerated inguinal hernia requiring emergency surgery Pregnancy Patients with chronic pain due to arthritis, migraine or other illness requiring regular intake of pain relieve (paracetamol, NSAID etc) Active cancer History of psychiatric or additive disorder that prevent the patient from participating in the trial Co-existing inflammatory disease Co-existing immunological disease that requires medication of any kind
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandros Nikolaou Valsamidis
Phone
0045 79973539
Email
alexandros.nikolaou.valsamidis@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Festersen Nielsen
Phone
0045 79976275
Email
michael.festersen.nielsen@rsyd.dk
Facility Information:
Facility Name
Sygehus Soenderjylland
City
Aabenraa
ZIP/Postal Code
6200
Country
Denmark
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12535413
Citation
McCormack K, Scott NW, Go PM, Ross S, Grant AM; EU Hernia Trialists Collaboration. Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev. 2003;2003(1):CD001785. doi: 10.1002/14651858.CD001785.
Results Reference
background
PubMed Identifier
32169186
Citation
Podolsky D, Novitsky Y. Robotic Inguinal Hernia Repair. Surg Clin North Am. 2020 Apr;100(2):409-415. doi: 10.1016/j.suc.2019.12.010. Epub 2020 Feb 1.
Results Reference
background
PubMed Identifier
31022677
Citation
Huerta S, Timmerman C, Argo M, Favela J, Pham T, Kukreja S, Yan J, Zhu H. Open, Laparoscopic, and Robotic Inguinal Hernia Repair: Outcomes and Predictors of Complications. J Surg Res. 2019 Sep;241:119-127. doi: 10.1016/j.jss.2019.03.046. Epub 2019 Apr 22.
Results Reference
background

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Transabdominal Preperitoneal Inguinal Hernia Repair

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