2025
Enhancing robot readiness for surgical trainees: validity and impact of a novel silicone model for rTAPP inguinal hernia repair
Willaume Christoffersen, Mette / Mads Marckman
Study I: validation (RR1)
Hypotheses: An anatomically updated silicone model can be used in educating surgical trainees using an objective assessment tool with a pass/fail score
Surgical trainees, hernia experts, and hernia patients support early robotic training in its importance
Aims: To gather validity data and establish a pass/fail setting on a Synthetic Surgery model.
Outcomes:
Primary: Pass/fail score evaluated by an objective assessment scale (benchmarking)
Secondary: Surgeon-reported (expert + novice) importance of robotic learning assessment score. Patient-reported importance of training assessment score. Expected submission end of 2026
2025
Dynamic vertical fascial traction for open abdomen treatment – impact on intra-abdominal pressure
Schaaf, Sebastian
Current status:
The study is currently in the preparatory phase prior to patient recruitment.
Ethical approval has been obtained from the Ethics Committee of the State Medical Association of Rhineland-Palatinate, with no ethical or legal objections to the conduct of the study.
The study has been successfully registered in the German Clinical Trials Register (DRKS), in accordance with regulatory requirements.
The first tranche of the EHS research grant has been requested following achievement of the initial milestone.
Study protocol (brief description):
This is a prospective, open-label, multicentre, randomized controlled trial comparing two treatment strategies for open abdomen management:
Standard of care: NPWT combined with vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM)
Intervention: NPWT combined with vertical fascial traction (VFT) using the fasciotens®Abdomen device
The primary objective is to evaluate whether NPWT + VFT leads to a superior reduction in intra-abdominal pressure (IAP) compared to VAWCM. The study plans to include adult patients requiring open abdomen treatment, with a total sample size of approximately 32 patients.
Next steps and timeline:
Currently, we are in the process of recruiting participating study centers.
Initiation of patient recruitment is planned for mid-2026.
The anticipated study duration is approximately 24 months from first patient inclusion to completion of follow-up.
Expected to be finished 2028/2029.
2025
[Currently no title]
Kaushiki, Singh
Study Protocol
Background:
Post-operative perineal herniae (POPH) can occur in up to 45% of patients following pelvic resectional surgery for recurrent or locally advanced colorectal cancer (1). POPH can cause severe symptoms for patients such as perineal lumps, discomfort preventing sitting and/or standing, obstruction, fistulation and skin breakdown (2). Research on POPH is hindered by the lack of consistency in reporting these herniae and the outcomes resulting from their management. There is no consensus on a definition for these herniae and existing definitions are inapplicable in patients who underwent extensive resections which included the pelvic floor and bony landmarks.
Aim:
To develop a definition, classification and core outcome dataset for post-operative perineal herniae (POPH) which accounts for patient symptoms, impact on their quality of life (QoL), radiological findings and lack of standard anatomical landmarks.
Trial design:
Mixed-methods qualitative study split into four phases with retrospective analysis of patient quality of life and radiological findings.
Expected date for completion of whole project: Autumn 2027.
2024
Understanding Patient-Centred Outcomes Following Umbilical Hernia Repair: A Patient Focus Group Study (HEAR-U)
Gilmore, Katie
Project:
Obtained IRAS ethical approval for the study in January 2026 (IRAS No. 351116), and recruitment is currently underway.
At present, I have recruited 13 participants, which is over halfway toward my target sample of 24 patients for the planned focus groups. The focus group discussions conducted so far have been extremely productive and have generated valuable insights into patient experiences, recovery priorities, and perspectives on outcomes following umbilical hernia repair.
The study is a qualitative descriptive study using semi-structured patient focus groups to explore which outcomes matter most to patients after umbilical hernia surgery. The overall aim is to develop a set of patient-centred outcome measures to better inform future hernia research and clinical practice.
Data collection is ongoing, with completion of recruitment and focus groups anticipated by the end of June 2026, followed by thematic analysis of the data and Expected preparation of manuscripts for publication end of 2026.
2023
Impact of the COVID-19 Pandemic on the Management of Groin Hernia Repairs: A Nationwide Population-Based Study From the Swedish Hernia Register
Stolt, Ramia
Objective: The aim is to assess the impact of COVID-19 pandemic on delays in elective surgeries for symptomatic groin hernias in Sweden.
Background: In Sweden, over 16,000 groin hernia repairs are performed annually, primarily in elective daycare settings. The COVID-19 pandemic led to the temporary postponement of all elective surgeries to reallocate healthcare resources and limit viral transmission.
Methods: This nationwide population-based study utilizing data from the Swedish Hernia Register compared groin hernia repairs before (2015-2019) and during (2020-2021) the pandemic. Multivariable logistic regression analysis stratified by gender was employed for the outcomes. The main outcomes were risks of emergency repair, severe complications (Clavien-Dindo ≥3b), 30-day mortality, and reoperation for recurrence.
Results: A total of 109,459 groin hernia repairs (n = 98 156 in men and n = 11 303 in women) were analyzed. The number of elective repairs declined by 22.9%, while emergency repairs only increased by 2.2% in 2020. Women had a higher risk of emergency repair during the pandemic (odds ratio: 1.38, P < 0.001) and presented notably higher crude rates of 30-day mortality and bowel resection compared with men in both cohorts. However, the overall risks in the population remained stable despite these shifts.
Conclusions: “Watchful waiting” for symptomatic groin hernias due to postponement of elective repairs in men appears safe regarding the risks of emergency repair and severe complications, in contrary to women. While elective repairs can temporally be deferred during crises, careful consideration should be given to women. Given this large-scale study, watchful waiting may not be appropriate for women in future healthcare crises, warranting further investigations.
2022
The FascioPig Study: Histological and biomechanical effects on the abdominal wall compartments (muscles/fascia) by intraoperative fascial traction as an alternative to component separation in the treatment of complex abdominal wall hernias
Theodorou, Alexios
Title:
The FascioPig Study: Histological and biomechanical effects on the abdominal wall compartments (muscles/fascia) by intraoperative fascial traction as an alternative to component separation in the treatment of complex abdominal wall hernias. An experimental study on pigs.
Team:
PI: Alexis Theodorou
Apostolos Papalois, Nikolaos Memos, Elisaios Kontis, Manousos Konstantoulakis, Dieter Berger
Timeline:
Currently underway with the experimental part of the study. Completion of experimental part is scheduled within 2026.
Goal of the Study:
The primary objective of the study is to detect and evaluate the histopathological changes in the myofascial planes of the abdominal wall through the application of intraoperative fascial traction. Expected submission end of 2026/2027.
2021
Strength of small-bites abdominal wall closure using different suturing methods and materials in an experimental animal model.
Lange, Johan / Floris den Hartog
Purpose: Using small instead of large bites for laparotomy closure results in lower incidence of incisional hernia, but no consensus exists on which suture material to use. This study aimed to compare five different closure strategies in a standardized experimental setting.
Methods: Fifty porcine abdominal walls were arranged into 5 groups: (A) running 2/0 polydioxanone; (B) interlocking 2/0 polydioxanone; (C) running size 0 barbed polydioxanone; (D) running size 0 barbed glycolic acid and trimethylene carbonate; (E) running size 0 suturable polypropylene mesh. The small-bites technique was used for linea alba closure in all. The abdominal walls were divided into a supra- and infra-umbilical half, resulting in 20 specimens per group that were pulled apart in a tensile testing machine. Maximum tensile force and types of suture failure were registered.
Results: The highest tensile force was measured when using barbed polydioxanone (334.8 N ± 157.0), but differences did not reach statistical significance. Infra-umbilical abdominal walls endured a significantly higher maximum tensile force compared to supra-umbilical (397 N vs 271 N, p < 0.001). Barbed glycolic acid and trimethylene carbonate failed significantly more often (25% vs 0%, p = 0.008).
Conclusion: Based on tensile force, both interlocking and running suture techniques using polydioxanone, and running sutures using barbed polydioxanone or suturable mesh, seem to be suitable for abdominal wall closure. Tensile strength was significantly higher in infra-umbilical abdominal walls compared to supra-umbilical. Barbed glycolic acid and trimethylene carbonate should probably be discouraged for fascial closure, because of increased risk of suture failure.
2020
The effect of an abdominal binder on postoperative outcome after open incisional hernia repair in sublay technique: a multicenter, randomized pilot trial (ABIHR‑II)
Paasch, Christoph
Study I: validation (RR1)
Hypotheses: An anatomically updated silicone model can be used in educating surgical trainees using an objective assessment tool with a pass/fail score
Surgical trainees, hernia experts, and hernia patients support early robotic training in its importance
Aims: To gather validity data and establish a pass/fail setting on a Synthetic Surgery model.
Outcomes:
Primary: Pass/fail score evaluated by an objective assessment scale (benchmarking)
Secondary: Surgeon-reported (expert + novice) importance of robotic learning assessment score. Patient-reported importance of training assessment score. Expected submission end of 2026
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