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

Umbilical Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01201564
• Other study ID #: IPOM-46/10
• Status: Terminated
• Phase: Phase 4
• Start date: July 2010
• Est. completion date: December 2018

Study information

• Verified date: May 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 306
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Umbilical
• Umbilical Hernia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Diakoniekrankenhaus Rotenburg (Wuemme) gGmbH	Rotenburg	Niedersachsen
Switzerland	University Hospital Basel	Basel
Switzerland	Luzerner Kantonsspital	Luzern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Clinical Trial Unit, University Hospital Basel, Switzerland

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & 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. Review. German. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Lau H, Patil NG. Umbilical hernia in adults. Surg Endosc. 2003 Dec;17(12):2016-20. Epub 2003 Oct 28. Review. — View Citation

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. — View Citation

Mayo WJ. VI. An Operation for the Radical Cure of Umbilical Hernia. Ann Surg. 1901 Aug;34(2):276-80. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	early wound complications	wound infection (with or without removal of the mesh); wound necrosis; wound hematoma	30 days after operation
Primary	late wound complications	wound infection (with or without removal of the mesh); wound necrosis; wound hematoma	1 year after operation
Secondary	complication rate perioperative	major bleeding; bowel injury	intraoperative complications will be recorded immediately after finishing the operation
Secondary	duration of operation	measured in minutes according to operations protocol (duration cut - suture)	the duration will be recorded immediately after finishing the operation
Secondary	hospital stay	measured in days	will be measured after discharge of the patient
Secondary	umbilical hernia recurrence rate	the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan	30 days
Secondary	umbilical hernia recurrence rate	the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan	1 year
Secondary	umbilical hernia recurrence rate	the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan	3 years
Secondary	umbilical hernia recurrence rate	the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	complication rate postoperative	trocar site hernia; enteral fistula; persistent pain; re-operation	30 day
Secondary	complication rate postoperative	trocar site hernia; enteral fistula; persistent pain; re-operation	1 year
Secondary	complication rate postoperative	trocar site hernia; enteral fistula; persistent pain; re-operation	3 years
Secondary	complication rate postoperative	trocar site hernia; enteral fistula; persistent pain; re-operation	5 years
Secondary	pain score (Visual Analog Scale - VAS)	will be measured by the nurse according to Visual Analog Scale	24h post operative
Secondary	pain score (Visual Analog Scale - VAS)	will be measured by the nurse according to Visual Analog Scale	48h post operative
Secondary	pain score (Visual Analog Scale - VAS)	will be measured by the nurse according to Visual Analog Scale	immediately before discharge
Secondary	Quality of life (SF-36)	patients will be asked to fulfill validated SF-36 questionnaire	1 day pre-operative
Secondary	Quality of life (SF-36)	patients will be asked to fulfill validated SF-36 questionnaire	30 days postoperatively
Secondary	Quality of life (SF-36)	patients will be asked to fulfill validated SF-36 questionnaire	1 year postoperatively