Comparison of different durations of physical activity restrictions following incisional hernia repair in sublay technique, the 3N6 trial: A prospective clinical trial.
Chronic pain
DVT, deep vein thrombosis, SD, standard deviation
IH, Incisional hernia
IHR, Incisional hernia repair
Incisional hernia
PAR, Physical activity restrictions, CHD, coronary heart disease
Physical activity restrictions
Physical rest
Recurrence rate
Sublay technique
Journal
International journal of surgery protocols
ISSN: 2468-3574
Titre abrégé: Int J Surg Protoc
Pays: England
ID NLM: 101758186
Informations de publication
Date de publication:
2020
2020
Historique:
received:
22
04
2020
revised:
12
05
2020
accepted:
13
05
2020
entrez:
11
6
2020
pubmed:
11
6
2020
medline:
11
6
2020
Statut:
epublish
Résumé
Incisional hernias (IH) occur in 4 to 20% of cases following abdominal surgeries, often after laparotomies. In the US, there are 4 to 5 million laparotomies performed per year, which could lead to 400.000 to 1.000.000 IHs. Therefore, this disease accounts as an important social-economic factor. Furthermore, these hernias can lead to bowel incarcerations, chronic pain, and a decrease in quality of life. To guarantee sufficient wound healing and decrease the recurrence rate, physical activity restrictions (PAR) are recommended. The standard recommendations for PAR seem to vary from 0 to 12 weeks, but the evidence remains low due to a lack of clinical trials. Conducting the study at hand, we aim to provide more evidence on this topic. The 3N6 trial will be conducted as a national multicenter prospective trial with two study groups (n = 90), where the goal is to find matched pairs within the two groups. Patients who underwent open incisional hernia repair (IHR) in sublay technique will be enrolled. A patient in the 3-week PAR group will be matched to a patient in the 6-week PAR group based on heavy lifting, male gender, BMI > 30, and large hernia >7 cm. The primary endpoint is the duration of sick leave that patients require to return to work, by comparing PAR of 6 weeks with PAR of 3 weeks. The secondary endpoints are the recurrence rate, seroma formation, and chronic pain one year after surgery and postoperative complications within 30 days using Clavien-Dindo-classification. The findings will be published in a peer-reviewed journal. We may also present the findings at local and/or national conferences.
Sections du résumé
BACKGROUND
BACKGROUND
Incisional hernias (IH) occur in 4 to 20% of cases following abdominal surgeries, often after laparotomies. In the US, there are 4 to 5 million laparotomies performed per year, which could lead to 400.000 to 1.000.000 IHs. Therefore, this disease accounts as an important social-economic factor. Furthermore, these hernias can lead to bowel incarcerations, chronic pain, and a decrease in quality of life. To guarantee sufficient wound healing and decrease the recurrence rate, physical activity restrictions (PAR) are recommended. The standard recommendations for PAR seem to vary from 0 to 12 weeks, but the evidence remains low due to a lack of clinical trials. Conducting the study at hand, we aim to provide more evidence on this topic.
METHODS
METHODS
The 3N6 trial will be conducted as a national multicenter prospective trial with two study groups (n = 90), where the goal is to find matched pairs within the two groups. Patients who underwent open incisional hernia repair (IHR) in sublay technique will be enrolled. A patient in the 3-week PAR group will be matched to a patient in the 6-week PAR group based on heavy lifting, male gender, BMI > 30, and large hernia >7 cm. The primary endpoint is the duration of sick leave that patients require to return to work, by comparing PAR of 6 weeks with PAR of 3 weeks. The secondary endpoints are the recurrence rate, seroma formation, and chronic pain one year after surgery and postoperative complications within 30 days using Clavien-Dindo-classification.
DISSEMINATION
RESULTS
The findings will be published in a peer-reviewed journal. We may also present the findings at local and/or national conferences.
Identifiants
pubmed: 32518883
doi: 10.1016/j.isjp.2020.05.001
pii: S2468-3574(20)30016-4
pmc: PMC7270603
doi:
Types de publication
Journal Article
Langues
eng
Pagination
6-9Informations de copyright
Published by Elsevier Ltd on behalf of Surgical Associates Ltd.
Déclaration de conflit d'intérêts
The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Références
World J Surg. 2016 Jan;40(1):89-99
pubmed: 26423675
Chirurg. 2002 May;73(5):474-80
pubmed: 12089832
Surg Endosc. 2014 Feb;28(2):353-79
pubmed: 24232044
Br J Surg. 1983 Oct;70(10):599-600
pubmed: 6626921
Surg Endosc. 2019 Oct;33(10):3069-3139
pubmed: 31250243
Surg Endosc. 2014 Feb;28(2):380-404
pubmed: 24043642
Ann Surg. 2004 Oct;240(4):578-83; discussion 583-5
pubmed: 15383785
Connect Tissue Res. 1981;9(1):25-31
pubmed: 6456124
Surg Endosc. 2014 Jan;28(1):2-29
pubmed: 24114513
Surg Endosc. 2006 Nov;20(11):1671-4
pubmed: 17001442
Surg Endosc. 2007 Apr;21(4):555-9
pubmed: 17364151
Ann Surg. 2004 Aug;240(2):205-13
pubmed: 15273542
Int J Surg. 2018 May;53:320-325
pubmed: 29656131
Ann Med Surg (Lond). 2019 Jun 15;44:5-12
pubmed: 31249685