Hernia reduction following laparotomy using small stitch abdominal wall closure with or without mesh augmentation
Organizational Data
- DRKS-ID:
- DRKS00017517
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2019-06-24
- Last update in DRKS:
- 2023-01-20
- Registration type:
- Prospective
Acronym/abbreviation of the study
HULC
URL of the study
No Entry
Brief summary in lay language
Incisional hernias are one of the most frequent complications following open abdominal surgeries with a rate of 10-30%. Incisional hernias cause additional costs and reduced quality of life. In Germany, more than 51,000 hernia surgeries are performed annually, with a recurrence rate of up to 30%. Therefore, the prevention of incisional hernias is crucial. Technical improvements in recent years, such as the prophylactic insertion of a mesh or the closure of the abdominal wall in the so-called small stitches technique significantly reduce the rate of incisional hernias. The aim of the HULC study is to investigate whether the combination of both techniques leads to an additional reduction of hernia rates. The primary end point is the hernia rate within 24 months after the operation. Other endpoints include surgical site infections, 30-day morbidity and quality of life.
Brief summary in scientific language
Incisional hernias (IHs) are among the most frequent complications following abdominal surgery causing substantial morbidity and mortality. Despite studies on the optimal closing technique for laparotomies IH rates following abdominal surgery are reported to be between 10-30% in RCTs and rise up to 36% in certain subgroups. In Germany, more than 51,000 IH repairs are performed each year making it one of the most frequent operations. A recent multicentre RCT has verified the superiority of abdominal closure in small stitches technique using a slowly absorbable suture and an increased suture-length to wound-length ratio of ≥ 4 in terms of reduced IH frequency in comparison to standard abdominal wall closure. Another promising strategy to prevent IHs is the placement of a prophylactic mesh during primary fascial closure. The objective of the HULC trial is to investigate whether prophylactic onlay mesh augmentation (OMA) in addition to abdominal wall closure in small stitches technique (SST) reduces the rate of IH formation in patients undergoing elective midline laparotomy compared to SST alone.
Health condition or problem studied
- Free text:
- Scheduled elective abdominal operation via a midline laparotomy
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Closure of the midline incision with a slowly absorbable monofilament suture in small stitches technique and additional onlay mesh augmentation using a polypropylene mesh
- Arm 2:
- Closure of the midline incision with a slowly absorbable monofilament suture in small stitch technique
Endpoints
- Primary outcome:
- Incisional hernia rate within 24 months after intervention as defined by the European Hernia Society
- Secondary outcome:
- 1. Rate of superficial and deep surgical site infections according to Centers for Disease Control (CDC) criteria within one year in both groups; 2. Postoperative (30 day) morbidity according to the Dindo-Clavien classification; 3. Rate of non-infectious wound complications (hematoma, seroma) within 30 days after index Operation; 4. Rate of postoperative burst abdomen defined as missing continuity of the fascia in combination with wound dehiscence with consecutive reoperation within 30 days after index oeration; 5. Postoperative wound pain according to the numeric rating scale on postoperative days 5-7 and 30-35; 6. Quality of life measured with the SF-36 and EQ-5D questionnaires at baseline and at postoperative months 6, 12, and 24; 7. Length of postoperative hospital stay after index operation
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Klinik für Allgemein-, Viszeral- und Thoraxchirurgie Hamburg
- Medical center Chirurgische Klinik I, Allgemein-, Viszeral- und Gefäßchirurgie Aschaffenburg
- University medical center Klinik für Allgemein-, Viszeral- und Thoraxchirurgie Hamburg
- Medical center Chirurgische Klinik I, Allgemein-, Viszeral- und Gefäßchirurgie Aschaffenburg
- Medical center Allgemein-, Viszeral- und Thoraxchirurgie Langen
- University medical center Klinik für Allgemeine Chirurgie, Viszeral-, Gefäß- und Kinderchirurgie Homburg
- University medical center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Heidelberg
- University medical center Universitätsklinik für Viszerale, Gefäß- und Endokrine Chirurgie Halle/Saale
- Medical center Chirurgie I Rheinland Klinikum Lukaskrankenhaus Neuss
- University medical center Klinik für Allgemeine, Viszeral- und Transplantationschirurgie Tübingen
- Medical center GRN-Klinik Sinsheim, Allgemein-, Viszeral- und Gefäßchirurgie Sinsheim
- University medical center Klinik und Poliklinik für Allgemein-, Viszeral-, Transplantations-, Gefäß- und Kinderchirurgie Würzburg
- Medical center Josephs-Hospital Warendorf, Klinik für Allgemein-Gefäß- und Visceralchirurgie Warendorf
- Medical center Allgemein-, Viszeral- und Thoraxchirurgie, Bundeswehrkrankenhaus Ulm Ulm
- University medical center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Klinikum der Universität München München
- University medical center Klinik und Poliklinik für Chirurgie, Klinikum rechts der Isar der Technischen Universität München München
- Medical center Klinik für Allgemein- und Viszeralchirurgie; Krankenhaus Bietigheim-Vaihingen Bietigheim
Recruitment period and number of participants
- Planned study start date:
- 2019-07-01
- Actual study start date:
- 2019-08-12
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 812
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- 1. Elective abdominal operation via a midline laparotomy 2. Planned clean or clean-contaminated operations according to the Centre for Disease Control (CDC) definition 3. Patient age at least 18 years 4. Ability to understand the nature and extent of the trial and to give written informed consent. 5. Written informed consent 6. Life expectancy at least 2 years
Exclusion Criteria
1. American Society of Anaesthesiologists (ASA) grade > 3 2. Pregnant or lactating woman 3. Midline laparotomy within the last 60 days prior to trial intervention 4. Previous incisional abdominal hernia or fascial dehiscence 5. Planned relaparotomy via the midline incision within 2 years after trial intervention 6. Concurrent abdominal wall infections 7. Participation in another intervention-trial with interference of intervention and/or outcome of this study
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum UlmAlbert-Einstein-Allee 2989081 UlmGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinik für Allgemein- und ViszeralchirurgieProf. Dr. med. André L. MihaljevicAlbert-Einstein-Allee 2389081 UlmGermany
- Telephone:
- 0731-50053502
- Fax:
- 0731-50053503
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Klinik für Allgemein- und ViszeralchirurgieProf. Dr. med. André L. MihaljevicAlbert-Einstein-Allee 2389081 UlmGermany
- Telephone:
- 0731-50053502
- Fax:
- 0731-50053503
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Klinik für Allgemein- und ViszeralchirurgieProf. Dr. med. André L. MihaljevicAlbert-Einstein-Allee 2389081 UlmGermany
- Telephone:
- 0731-50053502
- Fax:
- 0731-50053503
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Deutsche ForschungsgemeinschaftKennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dfg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät HeidelbergAlte Glockengießerei 11/169115 HeidelbergGermany
- Telephone:
- +49-6221-338220
- Fax:
- +49-6221-3382222
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2019-05-07
- Ethics committee number:
- S-361/2019
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-06-11
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry