Comparative Study Matching Intraperitoneal Onlay Mesh (IPOM) and Sublay Mesh to Treat Umbilical Hernia

NCT01201564 | Terminated Phase 4

• 1 other identifier: IPOM-46/10
• Study Type: interventional
• Target: 306
• Locations: 2 countries
• Sites: 3

Brief Summary

This study is designed to compare two techniques for operative care of umbilical hernia in adults regarding wound complications, wound side fluid collections, recurrence rate, postoperative pain, duration of hospitalization and quality of life. The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind the rectus muscle after small incision close to the belly button.

Conditions

Umbilical Hernia

Keywords

umbilical hernia,; wound complications,; mesh repair, IPOM,; quality of life,; sublay mesh repair,; recurrence rate

Outcome Measures

Primary Outcomes (2)

• early wound complications

  * wound infection (with or without removal of the mesh) * wound necrosis * wound hematoma

  30 days after operation

• late wound complications

  * wound infection (with or without removal of the mesh) * wound necrosis * wound hematoma

  1 year after operation

Secondary Outcomes (20)

• complication rate perioperative

  intraoperative complications will be recorded immediately after finishing the operation

• duration of operation

  the duration will be recorded immediately after finishing the operation

• hospital stay

  will be measured after discharge of the patient

• umbilical hernia recurrence rate

  30 days

• umbilical hernia recurrence rate

  1 year

Study Arms (2)

intraperitoneal onlay mesh repair

ACTIVE COMPARATOR

Procedure: intraperitoneal onlay mesh repair

sublay mesh repair

ACTIVE COMPARATOR

Procedure: sublay mesh repair

Interventions

intraperitoneal onlay mesh repair PROCEDURE

The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind des rectus muscle after small incision close to the belly button.

intraperitoneal onlay mesh repair

sublay mesh repair PROCEDURE

The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind des rectus muscle after small incision close to the belly button.

sublay mesh repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent
• patient age: ≥ 18 years
• elective surgery for umbilical hernia
• hernia diameter ≥ 1cm

You may not qualify if:

• previous history of median laparotomy
• navel site infection
• contraindication for general anaesthesia
• American Society of Anesthesiologists (ASA) score \>IV
• pregnancy
• cirrhosis of the liver (CHILD B and C) and/or ascites
• cytostatic therapy
• incarcerated hernia
• recurrent hernia

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator

Study Sites (3)

Diakoniekrankenhaus Rotenburg (Wuemme) gGmbH

Rotenburg (Wümme), Lower Saxony, 27356, Germany

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

Location

Related Publications (8)

• Benhidjeb T, Benecke C, Strik MW. [Incisional hernia repair: sublay or intraperitoneal onlay mesh (IPOM)?]. Zentralbl Chir. 2008 Sep;133(5):458-63. doi: 10.1055/s-2008-1076954. Epub 2008 Oct 15. German.

  PMID: 18924044 BACKGROUND

• Lau H, Patil NG. Umbilical hernia in adults. Surg Endosc. 2003 Dec;17(12):2016-20. doi: 10.1007/s00464-003-9027-7. Epub 2003 Oct 28.

  PMID: 14574545 BACKGROUND

• Mayo WJ. VI. An Operation for the Radical Cure of Umbilical Hernia. Ann Surg. 1901 Aug;34(2):276-80. doi: 10.1097/00000658-190107000-00021. No abstract available.

  PMID: 17861015 BACKGROUND

• Luijendijk RW, Hop WC, van den Tol MP, de Lange DC, Braaksma MM, IJzermans JN, Boelhouwer RU, de Vries BC, Salu MK, Wereldsma JC, Bruijninckx CM, Jeekel J. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med. 2000 Aug 10;343(6):392-8. doi: 10.1056/NEJM200008103430603.

  PMID: 10933738 BACKGROUND

• Venclauskas L, Silanskaite J, Kiudelis M. Umbilical hernia: factors indicative of recurrence. Medicina (Kaunas). 2008;44(11):855-9.

  PMID: 19124962 BACKGROUND

• Hilling DE, Koppert LB, Keijzer R, Stassen LP, Oei IH. Laparoscopic correction of umbilical hernias using a transabdominal preperitoneal approach: results of a pilot study. Surg Endosc. 2009 Aug;23(8):1740-4. doi: 10.1007/s00464-008-0177-5. Epub 2008 Nov 18.

  PMID: 19015918 BACKGROUND

• Forbes SS, Eskicioglu C, McLeod RS, Okrainec A. Meta-analysis of randomized controlled trials comparing open and laparoscopic ventral and incisional hernia repair with mesh. Br J Surg. 2009 Aug;96(8):851-8. doi: 10.1002/bjs.6668.

  PMID: 19591158 BACKGROUND

• Bullinger M. [Assessment of health related quality of life with the SF-36 Health Survey]. Rehabilitation (Stuttg). 1996 Aug;35(3):XVII-XXVII; quiz XXVII-XXIX. German.

  PMID: 8975342 BACKGROUND

MeSH Terms

Conditions

Hernia, Umbilical

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Oertli, Professor

  Departement of General Surgery, University Hospital Basel, Switzerland

  STUDY CHAIR

• Oleg Heizmann, MD

  Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany

  STUDY DIRECTOR

• Daniel Matz, MD

  Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: September 14, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

CH (2); DE (1)