NCT01778387

Brief Summary

The purpose of this prospective paper is to make a comparison between laparoscopic and opening approaches in ventral hernia repair, taking into account absence of recurrence in long - time (5 years), results centered at patient, especially satisfaction with expectations and improvement of normal physical activity, morbidity that particular form must include chronic pain, adjusted mortality through co-morbidities and, finally, prospective expenses, related to both effectiveness and utility

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

3.9 years

First QC Date

January 24, 2013

Last Update Submit

January 25, 2013

Conditions

Hernia, Ventral

Outcome Measures

Primary Outcomes (2)

  • Cost-effectiveness

    As effectiveness measure a clinic profit analysis was carried out by means of a composite analysis that integrates absence of recurrence, readmission, reoperation or disability.

    5 years

  • Cost-utility

    As an indirect measure of utility is used values obtained from questionnaires (HRQOL -Health Related Quality Of Life), assuming standard mean response in case of SF-36 and mean response standardized by standard deviation of difference in case of CVP-CG instruments between two types of repairs as well as effect size between preoperative value and postoperative one in case of SF-36. choice of measurement of HRQOL as a measure of utility was made under requirement that in absence of clinically relevant differences in mortality, recurrence or morbidity, a clinically relevant difference in HRQOL is a preference by patient and thus a choice between treatment alternatives.

    5 years

Study Arms (2)

Laparoscopic ventral hernia repair

ACTIVE COMPARATOR

Laparoscopic repair: Pneumoperitoneum was performed to 12 mmHg. Herniary contents and sac are reduced releasing adhesions with diathermy or harmonic scalpel. Defects are repaired with a polytetrafluoroethylene (PTFE) patch (Dual Mesh; W.L Gore and Associates, FlagstaV, AZ USA) with double crown fixation as technique of Carbajo et al, ensuring exceed 3 cm edge of defect, using 5mm tackers (Protack, Autosuture; Tyco Healthcare, USA), reducing intrabdominal pressure to 8 mmHg. All operations were performed by experienced surgeons, over than 40 laparoscopic ventral hernia repairs.

Procedure: Laparoscopic ventral hernia repair

Open ventral hernia repair

PLACEBO COMPARATOR

Open repair: Incision was made over hernia defect, reducing herniary contents by opening sac if it is necessary. We made 4 cm soft tissue flaps around edge of defect depending on available healthy fascial tissue. Chevrel technique with fascial closure using anterior rectus sheath with continuous and absorbable suture and placement of polypropylene mesh (Parietene standart polypropylene mesh, Covidien, Norwalk, CT) in an onlay position fixed with polypropylene suture.

Interventions

Laparoscopic ventral hernia repairPROCEDURE

Intraperitoneal ventral hernia repair with the use of Gore-tex Patch

Laparoscopic ventral hernia repair

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients above 18 years old, diagnosed
  • Primary or incisional ventral hernia (clinic and radiologic: abdominal wall CT scan), including recurrent ones,
  • Hernia estimated size from 20 to 225 cm2.

You may not qualify if:

  • Included type 4 or 5 of ASA (American Society of Anesthesiologist),
  • Disease limiting lifespan to less than 2 years,
  • Cirrhotic ascites,
  • Emergency surgery
  • intestinal obstruction,
  • strangulated hernia,
  • peritonitis,
  • Local or systemic infection,
  • failure of patient to ensure an at least 2 years follow-up or abandonment protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Infanta Elena

Huelva, 21005, Spain

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Pedro Naranjo-Rodríguez, Dr

    Surgery Dep. Complejo Hospitalario Huelva

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General and Gastrointestinal Surgery

Study Record Dates

First Submitted

January 24, 2013

First Posted

January 29, 2013

Study Start

January 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2012

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

ES(1)