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

Prospective Randomized Multicenter Trial Comparing Laparoscopic (IPOM) vs. Sublay Mesh Plasty for Umbilical Hernia in Adults

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.

Study Overview

• Status: Terminated
• Conditions: Umbilical Hernia
• Intervention / Treatment: Procedure: intraperitoneal onlay mesh repair; Procedure: sublay mesh repair

• Study Type: Interventional
• Enrollment (Actual): 306
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Niedersachsen
    • Rotenburg, Niedersachsen, Germany, 27356
      • Diakoniekrankenhaus Rotenburg (Wuemme) gGmbH
• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel
  • Luzern, Switzerland, 6000
    • Luzerner Kantonsspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intraperitoneal onlay mesh repair	Procedure: intraperitoneal onlay mesh repair; 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.
Active Comparator: sublay mesh repair	Procedure: sublay mesh repair; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication rate perioperative	major bleeding; bowel injury	intraoperative complications will be recorded immediately after finishing the operation
duration of operation	measured in minutes according to operations protocol (duration cut - suture)	the duration will be recorded immediately after finishing the operation
hospital stay	measured in days	will be measured after discharge of the patient
umbilical hernia recurrence rate	the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan	30 days
umbilical hernia recurrence rate	the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan	1 year
umbilical hernia recurrence rate	the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan	3 years
umbilical hernia recurrence rate	the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan	5 years
navel site seroma	the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm))	discharge day
navel site seroma	the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm))	after 30 days
navel site seroma	the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm))	after 1 year
complication rate postoperative	trocar site hernia; enteral fistula; persistent pain; re-operation	30 day
complication rate postoperative	trocar site hernia; enteral fistula; persistent pain; re-operation	1 year
complication rate postoperative	trocar site hernia; enteral fistula; persistent pain; re-operation	3 years
complication rate postoperative	trocar site hernia; enteral fistula; persistent pain; re-operation	5 years
pain score (Visual Analog Scale - VAS)	will be measured by the nurse according to Visual Analog Scale	24h post operative
pain score (Visual Analog Scale - VAS)	will be measured by the nurse according to Visual Analog Scale	48h post operative
pain score (Visual Analog Scale - VAS)	will be measured by the nurse according to Visual Analog Scale	immediately before discharge
Quality of life (SF-36)	patients will be asked to fulfill validated SF-36 questionnaire	1 day pre-operative
Quality of life (SF-36)	patients will be asked to fulfill validated SF-36 questionnaire	30 days postoperatively
Quality of life (SF-36)	patients will be asked to fulfill validated SF-36 questionnaire	1 year postoperatively

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Clinical Trial Unit, University Hospital Basel, Switzerland
• Investigators: Study Chair: Daniel Oertli, Professor, Departement of General Surgery, University Hospital Basel, Switzerland; Study Director: Oleg Heizmann, MD, Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany; Principal Investigator: Daniel Matz, MD, Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: July 19, 2010
• First Submitted That Met QC Criteria: September 13, 2010
• First Posted (Estimate): September 14, 2010

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: recurrence rate; quality of life,; umbilical hernia,; wound complications,; mesh repair, IPOM,; sublay mesh repair,
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia, Ventral; Hernia; Hernia, Umbilical
• Other Study ID Numbers: IPOM-46/10