NCT04700956

Brief Summary

Incisional hernia is a common condition after abdominal surgery. Because linea alba has less vascularity, incisional hernia more common in midline incisions. It is seen in the general population between 11-20%. In some high-risk situations, this rate increases up to 40-69% (abdominal aortic aneurysm, morbid obesity, colorectal surgery).It is known that incisional hernia that occurs in the postoperative period can lead to emergency surgical causes such as incarceration-strangulation, has a significant share in health expenses and seriously impairs the quality of life in patients.One of the methods tried to reduce incisional hernia is the use of mesh. But this abdominal closure technique is not used routinely in our country and the other countries. This study will be important of the studies in Turkey and world for patient selection in prophylactic mesh use, techniques to be applied and early / late results. The aim of the study is to compare the classical abdominal closure technique with use of mesh in order to minimize the incisional hernia and associated complications after midline laparotomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

December 19, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

1.5 years

First QC Date

December 19, 2020

Last Update Submit

August 16, 2022

Conditions

Incisional Hernia

Keywords

incisional herniaprophylacticmeshemergency surgery

Outcome Measures

Primary Outcomes (1)

  • primary outcome

    incisional hernia rate

    up to one year

Secondary Outcomes (10)

  • secondary outcome

    up to one months

  • secondary outcome

    up to one months

  • secondary outcome

    up to ten days

  • secondary outcome

    up to one months

  • secondary outcome

    up to one months

  • +5 more secondary outcomes

Study Arms (2)

the primary suture group

ACTIVE COMPARATOR

The linea alba will be closed to a ratio of 5mm / 5mm. Only the fascia will be sutured ; fat or muscle tissue will be avoided. Subcutaneous tissue will be closed with polyglactin 3/0 suture. The skin will be closed with a stapler.

Procedure: primary abdominal closure

mesh group

EXPERIMENTAL

After the fascia was closed with the same method, 5 cm of subcutaneous tissue will be dissected around the incision. The mesh will be placed in the supra-aponeurotic area (onlay) to a distance of laterally and cranial-caudally 5 cm from the fascia margins. The mesh used will be partially absorbable, light and large porous. After this procedure, the borders of the mesh will be fixed circumferentially on the abdominal wall using polypropylene suture to prevent the intestines from herniating on the mesh. Two subcutaneous drainage catheters will be placed in all patients with mesh.

Device: abdominal closure with prophylactic mesh

Interventions

primary abdominal closurePROCEDURE

The linea alba will be closed to a ratio of 5mm / 5mm. Only the fascia will be sutured ; fat or muscle tissue will be avoided. Subcutaneous tissue will be closed with polyglactin 3/0 suture. The skin will be closed with a stapler.

Also known as: primary abdominal closure with suture
the primary suture group
abdominal closure with prophylactic meshDEVICE

After the fascia was closed with the same method, 5 cm of subcutaneous tissue will be dissected around the incision. The mesh will be placed in the supra-aponeurotic area (onlay) to a distance of laterally and cranial-caudally 5 cm from the fascia margins. The mesh used will be partially absorbable, light and large porous. After this procedure, the borders of the mesh will be fixed circumferentially on the abdominal wall using polypropylene suture to prevent the intestines from herniating on the mesh. Two subcutaneous drainage catheters will be placed in all patients with mesh.

mesh group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being older than 18 years of age,
  • laparotomy with the midline incision of the abdomen,
  • all emergency surgery indications,
  • having at least two of the risk factors.

You may not qualify if:

  • Patients under 18 years of age,
  • elective surgeries,
  • off-midline incisions,
  • concurrent hernia,
  • laparoscopic surgery,
  • history of metastatic cancer,
  • life expectancy less than 2 years,
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Science University Konya City Hospital General Surgery Department

Konya, Turkey (Türkiye)

Location

Related Publications (9)

  • Jairam AP, Lopez-Cano M, Garcia-Alamino JM, Pereira JA, Timmermans L, Jeekel J, Lange J, Muysoms F. Prevention of incisional hernia after midline laparotomy with prophylactic mesh reinforcement: a meta-analysis and trial sequential analysis. BJS Open. 2020 Jun;4(3):357-368. doi: 10.1002/bjs5.50261. Epub 2020 Feb 14.

    PMID: 32057193RESULT

  • Argudo N, Iskra MP, Pera M, Sancho JJ, Grande L, Lopez-Cano M, Pereira JA. The use of an algorithm for prophylactic mesh use in high risk patients reduces the incidence of incisional hernia following laparotomy for colorectal cancer resection. Cir Esp. 2017 Apr;95(4):222-228. doi: 10.1016/j.ciresp.2017.03.010. Epub 2017 Apr 8. English, Spanish.

    PMID: 28400141RESULT

  • Bhangu A, Fitzgerald JE, Singh P, Battersby N, Marriott P, Pinkney T. Systematic review and meta-analysis of prophylactic mesh placement for prevention of incisional hernia following midline laparotomy. Hernia. 2013 Aug;17(4):445-55. doi: 10.1007/s10029-013-1119-2. Epub 2013 May 28.

    PMID: 23712289RESULT

  • Fischer JP, Basta MN, Wink JD, Krishnan NM, Kovach SJ. Cost-utility analysis of the use of prophylactic mesh augmentation compared with primary fascial suture repair in patients at high risk for incisional hernia. Surgery. 2015 Sep;158(3):700-11. doi: 10.1016/j.surg.2015.02.030. Epub 2015 Jul 15.

    PMID: 26189071RESULT

  • Kurmann A, Barnetta C, Candinas D, Beldi G. Implantation of prophylactic nonabsorbable intraperitoneal mesh in patients with peritonitis is safe and feasible. World J Surg. 2013 Jul;37(7):1656-60. doi: 10.1007/s00268-013-2019-4.

    PMID: 23568247RESULT

  • Llaguna OH, Avgerinos DV, Nagda P, Elfant D, Leitman IM, Goodman E. Does prophylactic biologic mesh placement protect against the development of incisional hernia in high-risk patients? World J Surg. 2011 Jul;35(7):1651-5. doi: 10.1007/s00268-011-1131-6.

    PMID: 21547421RESULT

  • Payne R, Aldwinckle J, Ward S. Meta-analysis of randomised trials comparing the use of prophylactic mesh to standard midline closure in the reduction of incisional herniae. Hernia. 2017 Dec;21(6):843-853. doi: 10.1007/s10029-017-1653-4. Epub 2017 Sep 1.

    PMID: 28864937RESULT

  • San Miguel C, Melero D, Jimenez E, Lopez P, Robin A, Blazquez LA, Lopez-Monclus J, Gonzalez E, Jimenez C, Garcia-Urena MA. Long-term outcomes after prophylactic use of onlay mesh in midline laparotomy. Hernia. 2018 Dec;22(6):1113-1122. doi: 10.1007/s10029-018-1833-x. Epub 2018 Oct 4.

    PMID: 30288617RESULT

  • Garcia-Urena MA, Lopez-Monclus J, Hernando LA, Montes DM, Valle de Lersundi AR, Pavon CC, Ceinos CJ, Quindos PL. Randomized controlled trial of the use of a large-pore polypropylene mesh to prevent incisional hernia in colorectal surgery. Ann Surg. 2015 May;261(5):876-81. doi: 10.1097/SLA.0000000000001116.

    PMID: 25575254RESULT

MeSH Terms

Conditions

Incisional Hernia

Interventions

Sutures

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

December 19, 2020

First Posted

January 8, 2021

Study Start

December 19, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)