Enhanced Recovery After Abdominal Wall Reconstruction

Hernia, Ventral Clinical Trial

— ERAWR  

Official title:

Enhanced Recovery After Abdominal Wall Reconstruction.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05467124
• Other study ID #: UCagliari_02
• Status: Not yet recruiting
• Start date: October 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The use of laparoscopy and the ERAS (Enhanced Recovery After Surgery) perioperative pathways are well defined in surgery and widely used worldwide.

Predicting the success or failure of ERAS has become a matter of interest, as there is evidence confirming that greater compliance with the items of ERAS improves clinical outcomes. However, the impact that every single item of ERAS programs may have on postoperative recovery remains unknown. Furthermore, the loss of conformity, or deviation from the pathway, is multifactorial and derives from different issues (organizational, cultural, etc.).

While data are available on the compliance of surgeons to ERAS pathways, it is impossible to establish which item is related to the benefits induced by ERAS. Regarding abdominal wall reconstruction (AWR) surgery, there is no uniform adherence to the ERAS protocol, often creating confusion about the effectiveness of the protocol itself.

The goal of this multicenter, prospective, international, observational study is to prospectively assess adherence to the ERAS protocol in AWR surgery and its effectiveness in patients undergoing elective surgery for ventral primary/incisional hernias.

The participating centers will consecutively enroll all patient candidates for an elective ventral or incisional hernia repair (open/laparoscopic/robotic/converted technique).

The present study will include all patients ≥18 years old, capable of expressing valid informed consent, with a ventral/incisional hernia diagnosis confirmed by CT/US scan, who will undergo elective surgery. For each patient, anthropometric and personal data (sex, age, BMI) and data relating to their health state (ASA Score, previous abdominal surgery, hernia site) will be collected. Intraoperative data will include the type of surgery and intraoperative complications. Data regarding the adherence/lack of adherence to each item of the ERAS protocol will be collected, and, in the case of non-adherence, the reason will be specified, choosing between "habit", "disagreement", and "lack of organizational pathway", "other".

During the post-operative period, all data regarding functional recovery will be recorded, i.e. the day of removal of the drainage, mobilization, return to bowel function, post-operative pain at first and third post-operative day and discharge, and length of hospitalization. Moreover, for each patient, data regarding post-operative complications will be collected and stratified by severity according to the Clavien-Dindo classification.

This research is observational; therefore, no interventional changes should be made to the daily clinical practice at each participating center. Patients <18 years old, patients unable to provide valid informed consent, and those who refuse to be included in the study will be excluded.

The study's primary objective is to evaluate adherence to the different items of the ERAS protocol for AWR surgery.

The study's secondary objective is to evaluate which item of the protocol can affect the post-operative recovery of patients undergoing AWR surgery.

The study's primary outcome is the compliance rate for each ERAS item for AWR surgery.

The secondary outcomes of the study are the evaluation of complications, length of hospital stay, and recovery time after AWR in relation to compliance with the ERAS items. In addition, the study will evaluate: the time to removal of the drainage tube, if placed (post-operative day, n.), post-operative mobilization (hours, n.), time to resumption of post-operative liquid diet after surgery (hours, n.), time to resumption of liquid diet after surgery (hours, n.), pain at I-II-III post-operative day (VAS Score), time to return to bowel function (gas) (hours, n.), time to return to bowel function (stools) (hours, n.), length of hospital stay (days, n), pain at discharge (VAS Score), post-operative complications (n, within 30 days), type of complication (if any). The complications will be classified according to Clavien-Dindo: Grade I complication according to Clavien-Dindo.

Statistical analyses will be performed with the SPSS 27 system (SPSS Inc., Chicago, IL, USA). Continuous data will be expressed as mean ± SD; categorical variables will be expressed as percentages. To compare continuous variables, an independent sample t-test will be implemented. The Wilcoxon Paired-Samples Test will be used as a non-parametric test similar to the paired-samples t-test used for continuous variables. The Chi-square test (or Fisher's exact test where appropriate) will be used to analyze categorical data. The results will be presented as 2-tailed values with statistical significance if p< 0.05. To adjust all other variables and make predictions, multivariate analyses will be performed with operative time or post-operative time or the occurrence of post-operative complications as dependent variables and with significant clinical and demographic characteristics as independent variables.

Description:

INCLUSION CRITERIA Patients undergoing AWR surgery with mesh repair for primary ventral/incisional hernia (laparoscopic/robotic/ open/converted); ASA class I - IV; Elective surgery; Able to give informed consent; Age ≥18 years.

EXCLUSION CRITERIA ASA class V; Pregnancy; Skin infection or presence of enterocutaneous fistula at the time of the surgical operation.

DURATION OF THE STUDY The enrollment period for the participating centers will last two months (01 August 2022 - 30 September 2022); 4 months is the scheduled period for patients' enrollment (01 October 2022 - 30 November 2022). The final list of the participating centers will be shared at the end of the centers' enrollment period. The planned follow-up is 30 days after surgery.

DATA COLLECTION All epidemiological, clinical and surgical data will be collected on a CFR that will be completed by accessing a protected data system. The link for accessing the completion of the CFR will be sent via email to only one contact person (Local Lead) of each participating center.

ETHICAL ASPECTS This is an international observational study; it will not attempt to change or modify the clinical practice of the participating center. Every clinical center attending the study will be responsible for Ethics Committee approval depending on the local policy for observational and non-interventional studies. This study will comply with the Italian legislation, the Declaration of Helsinki, and the principles of Good Clinical Practice. In Italy, the regulatory reference is represented by the Legislative Decree n.211 of 24/06/2003, DM 17/12/2004 on non-profit studies, DM 20 March 2008. The data will be collected anonymously, and patients will be identified by a code sequence to guarantee privacy protection under the Legislative Decree 196/2003, the European Regulation 2016/679, and the Resolution no. 52 of 24 July 2008. All potentially eligible patients will receive complete study information. To be included in the study, patients must give written consent to process personal data in anonymous and aggregate form (Legislative Decree 196/03 and the European Regulation 2016/679).

INFORMED CONSENT All patients eligible for the study will be provided with a specific information sheet, written in simple language, which will explain the purposes of the study and its general methods. The patient will then be asked to sign a specific informed consent form.

ROLE OF THE PROMOTER The study promoter will be responsible for implementing all the activities necessary for the proper conduct and management of the study.

PUBLICATION POLICY The Local Lead and one Collaborator from each center will be listed as Co-authors in the final publication. Every local investigator is responsible for entering data on an online case report form for every patient included in the study. Data will be published as a pool from all participating surgical units. Data from the ERAWR study will be published irrespective of findings. Results will be published on ClinicalTrials.Gov, and each manuscript generated based on the registry will be disseminated to all participating centers before final publication.

SAFETY ISSUES None.

FUNDING This research has not received any specific grant from the public, commercial, or not-for-profit funding agencies.

FINANCIAL AND INSURANCE Not applicable.

STORAGE OF THE DOCUMENTATION The local lead at each participating center will take care to keep access to the regulatory authorities for seven years after the end of the study, the following documents: a copy of the final protocol of the study (and any amendments) approved by the Administrative Authorities and the Ethics Committee; informed consent (signed and the local lead) and consent to data processing (signed by the patient and the local lead); the copies of the data collection forms.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing AWR surgery with mesh repair for primary ventral/incisional hernia (laparoscopic/robotic/ open/converted).

• ASA class I - IV.

• Elective surgery.

• Able to give informed consent.

• Age =18 years.

Exclusion Criteria:

• ASA class V.

• Pregnancy.

• Skin infection or presence of enterocutaneous fistula at the time of the surgical operation.

Related Conditions & MeSH terms

• Hernia
• Hernia Incisional
• Hernia, Abdominal
• Hernia, Umbilical
• Hernia, Ventral
• Incisional Hernia
• Internal Hernia

Intervention

Procedure:
• Enhanced Recovery After Surgery (ERAS) protocol
Application of standardized Enhanced Recovery After Surgery (ERAS) protocol for patients undergoing abdominal wall reconstruction for primary/incisional ventral hernias.

Locations

Country	Name	City	State
Italy	Cagliari University Hospital	Cagliari

Sponsors (7)

Lead Sponsor

Collaborator

Mauro Podda

Alberto Sartori, UOC Chirurgia Montebelluna e Castelfranco Veneto, Italy., Benedetto Ielpo, HPB Surgery Unit, Hospital del Mar, Barcelona, Spain., Francesco Pata, General Surgery Unit, Nicola Giannettasio Hospital, Corigliano-Rossano, Italy., Gianluca Pellino, Università degli Studi della Campania 'Luigi Vanvitelli', Naples, Italy., Jacopo Andreuccetti, Department of Surgery, Spedali Civili Riuniti of Brescia, Italy., Marco Milone, Federico II University of Naples, Italy.

Country where clinical trial is conducted

Italy, 

References & Publications (9)

Aarts MA, Okrainec A, Glicksman A, Pearsall E, Victor JC, McLeod RS. Adoption of enhanced recovery after surgery (ERAS) strategies for colorectal surgery at academic teaching hospitals and impact on total length of hospital stay. Surg Endosc. 2012 Feb;26( — View Citation

Boulind CE, Yeo M, Burkill C, Witt A, James E, Ewings P, Kennedy RH, Francis NK. Factors predicting deviation from an enhanced recovery programme and delayed discharge after laparoscopic colorectal surgery. Colorectal Dis. 2012 Mar;14(3):e103-10. doi: 10. — View Citation

ERAS Compliance Group. The Impact of Enhanced Recovery Protocol Compliance on Elective Colorectal Cancer Resection: Results From an International Registry. Ann Surg. 2015 Jun;261(6):1153-9. doi: 10.1097/SLA.0000000000001029. — View Citation

ERAS Society-Reference Centres Interactive Audit. 2016. 14-7- 2016. Ref Type: Online Source

Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011 May;146(5):571-7. doi: — View Citation

Messenger DE, Curtis NJ, Jones A, Jones EL, Smart NJ, Francis NK. Factors predicting outcome from enhanced recovery programmes in laparoscopic colorectal surgery: a systematic review. Surg Endosc. 2017 May;31(5):2050-2071. doi: 10.1007/s00464-016-5205-2. — View Citation

Sartori A, Botteri E, Agresta F, Gerardi C, Vettoretto N, Arezzo A, Pisanu A, Di Saverio S, Campanelli G, Podda M. Should enhanced recovery after surgery (ERAS) pathways be preferred over standard practice for patients undergoing abdominal wall reconstruc — View Citation

Senagore AJ. Adoption of Laparoscopic Colorectal Surgery: It Was Quite a Journey. Clin Colon Rectal Surg. 2015 Sep;28(3):131-4. doi: 10.1055/s-0035-1560040. Review. — View Citation

The UK National Bowel Cancer Audit Project 2015 (2015) Health and Social Care Information Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The study's primary outcome is the compliance rate for each ERAS item for abdominal wall reconstruction (AWR) surgery.	Level of compliance with each item of the ERAS protocol.	30 days
Secondary	Complications	Post-operative complications, stratified according to the Clavien-Dindo classification (number, percentage).	30 days
Secondary	Length of hospital stay	Length of hospital stay after AWR surgery (days +/- Standard Deviation)	30 days
Secondary	Time to removal of the drainage	Time to removal of the drainage (days +/- Standard Deviation)	30 days
Secondary	Time to post-operative mobilization	Time to post-operative mobilization (hours +/- Standard Deviation)	7 days
Secondary	Time to resumption of post-operative liquid diet after surgery	Time to resumption of post-operative liquid diet after surgery (hours +/- Standard Deviation)	7 days
Secondary	Time to resumption of liquid diet after surgery	Time to resumption of liquid diet after surgery (hours +/- Standard Deviation)	7 days
Secondary	Pain at I-II-III post-operative day	Pain at I-II-III post-operative day (Visual Analogue Scale -VAS- From 0 to 10. Higher scores mean worse outcome)	7 days
Secondary	Time to return to bowel function (gas)	Time to return to bowel function (gas) (days +/- Standard Deviation)	30 days
Secondary	Time to return to bowel function (stools)	Time to return to bowel function (stools) (days +/- Standard Deviation)	30 days
Secondary	Pain at discharge	Pain at discharge (VAS score)	30 days