Clinical Trial: Primary Fascial Closure With Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Primary Fascial Closure With Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial

Brief Summary: This study is comparing the outcomes patients undergoing LVHR, PFC as opposed to a bridged repair with assessment of patient reported satisfaction and function at 6 months of follow-up.

Detailed Summary:

Introduction: While randomized controlled trials have demonstrated that laparoscopic ventral hernia repair (LVHR) as compared to open repair is associated with decreased rates of surgical site infection (SSI) and shorter lengths of hospital stay, the adoption of LVHR has been limited. Less than one-fourth of ventral hernias are repaired with a laparoscopic approach in the United States. One of the main reasons cited for the lack of widespread adoption of LVHR is failure to improve patient symptoms. Following LVHR, up to 70% of patients continue to complain of an abdominal bulge and one-third of patients complain of poor function. The investigators have previously reported that primary fascial closure (PFC) with LVHR is feasible and when compared to case-matched controls, PFC improved outcomes of recurrence, bulging, and patient function.

Hypotheses: Primary Hypothesis: In patients undergoing LVHR, PFC as opposed to a bridged repair will improve patient reported satisfaction and function at 6 months of follow-up. Secondary Hypotheses: (1) PFC is safe and feasible to perform by general surgeons facile at LVHR. Compared to bridged LVHR, (2) PFC will decrease recurrence rates and (3) PFC will decrease the rate of clinician-diagnosed eventration following LVHR.

Methods: A randomized controlled trial to compare the outcomes of two methods of LVHR: bridged repair with mesh or PFC with mesh will be performed. PFC is estimated to improve patient satisfaction and patient function from composite scores on the validated and hernia-specific Modified Activities Assessment Scale (best score of 100) of 72 ± 14 to 79 ± 11. Assuming 20% attenuation in treatment effect, a two-sided alpha of 0.05 and beta of 0.20, and 20% dropout rate, 176 patients will need to be randomized (n=88/group). The investigators' healthcare system perform
Sponsor: The University of Texas Health Science Center, Houston

Current Primary Outcome: Patient Satisfaction and function [ Time Frame: 6 months ]

Patient satisfaction and function evaluated through the modified Activities Assessment Scale, a validated, hernia-specific score that can be compared pre- and post-operative


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Surgical site infection [ Time Frame: 30 days after surgery ]
    Surgical site infection will be defined by the Center for Disease Control and Prevention (CDC) definition of a surgical site infection.
  • Hernia recurrence and clinical bulging/eventration [ Time Frame: 2 years after surgery ]

    number of patients with a clinical hernia recurrence: A clinician blinded to the treatment allocation will determine if the patient has a clinical hernia recurrence defined as any palpable defect of the anterior abdominal wall.

    -Radiographic hernia recurrence: If the clinical team orders a CT scan, results of a radiographic hernia recurrence will be reported. Radiographic hernia recurrence will be defined as any defect of the anterior abdominal wall and will be determined by a blinded radiologist and surgeon not part of the clinical care team.

  • Clinical bulging/eventration [ Time Frame: 2 years after surgery ]

    number patients with clinical bulging/eventration: Clinician reported eventration: A study coordinator blinded to the treatment allocation will determine if the patient has clinical eventration defined as any bulge of tissue or mesh beyond the natural contour of the abdomen on supine flexion.

    -Patient reported eventration: A study coordinator blinded to the treatment allocation will ask the patient if they feel that they still have their hernia bulge.



Original Secondary Outcome: Same as current

Information By: The University of Texas Health Science Center, Houston

Dates:
Date Received: February 2, 2015
Date Started: March 2015
Date Completion: May 2019
Last Updated: May 8, 2017
Last Verified: May 2017