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出境医 / 临床实验 / Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair

Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair

Study Description
Brief Summary:
This study evaluates the effect of anterior gastropexy (one or more sutures fixing the stomach to the inner abdominal wall) on improving durability of paraesophageal hernia repair. Half of participants will receive anterior gastropexy, while the other half will not. The hypothesis is that anterior gastropexy will help to prevent paraesophageal hernias from recurring.

Condition or disease Intervention/treatment Phase
Paraesophageal Hernia Hiatal Hernia Large Procedure: Anterior Gastropexy Not Applicable

Detailed Description:

Paraesophageal hernias are hernias in which the stomach and/or other abdominal organs herniate through the diaphragm into the chest. This abnormal anatomy can lead to acid reflux, trouble swallowing, and shortness of breath, and can also be a risk factor for surgical emergencies involving the stomach. For these reasons, the Society of American Gastrointestinal and Endoscopic Surgeons has strongly recommended that all symptomatic paraesophageal hernias be repaired.

These repairs are technically challenging, and the best available evidence suggests that more than half of patients undergoing repair will have radiographic hernia recurrence at 5 years after surgery. There has been suggestion that use of anterior gastropexy - in which suture is used to affix the stomach to the anterior abdomen - may reduce recurrence rates. However, it is uncertain whether this data is reliable. While some surgeons use anterior gastropexy routinely because they believe it reduces recurrence, other surgeons do not use anterior gastropexy due to the concern that patients will have short-term pain at the suture site. This study aims to evaluate the effect of using anterior gastropexy on recurrence rates after paraesophageal hernia repair, compared to not using anterior gastropexy.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a double-blinded, registry-based, randomized control trial comparing anterior gastropexy to no anterior gastropexy in paraesophageal hernia repair. This will be a two-arm trial with intervention 1: intervention 2 and control allocation ratio of 1:1.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will not be informed regarding the treatment that they received until they complete 1-year follow-up. Imaging will be reviewed at the end of the study period by surgeons who are blinded to treatment group.
Primary Purpose: Treatment
Official Title: Two-Armed Double-Blinded Registry-Based Randomized Control Trial Comparing Anterior Gastropexy to No Anterior Gastropexy for Paraesophageal Hernia Repair
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : July 1, 2024
Arms and Interventions
Arm Intervention/treatment
No Intervention: Intervention 1 (Control)
No anterior gastropexy will be performed.
Experimental: Intervention 2 (Treatment)
Anterior gastropexy will be performed.
 Procedure: Anterior Gastropexy
Two permanent sutures will be introduced into the abdomen and placed along the lesser curvature of the stomach. A suture passer will be used to grasp the ends of the sutures to externalize them at separate fascial punctures. At time of abdominal desufflation, the sutures will be tied and the incision closed per individual surgeon practice.
Outcome Measures
Primary Outcome Measures :
  1. Paraesophageal Hernia Recurrence [ Time Frame: 1 year ]
    Either radiographic evidence of hernia recurrence on an upper GI study or need for reoperation secondary to paraesophageal hernia recurrence


Secondary Outcome Measures :
  1. Mean Change from Baseline in GERD-HRQL Scores at 30 days and 1 year [ Time Frame: 30 day follow up (15-45 days postop) and 1 year follow-up (9-15 months) ]
    The Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) is a 10-item instrument to quantify symptom severity in gastroesophageal reflux disease. Scores on individual items are summed and may range from 0 to 50, with higher scores indicating greater severity of symptoms and worse quality of life. Additionally, there is a question about global satisfaction with quality of life, which may be answered as "satisfied," "neutral," or "dissatisfied." The percentages of these categories will be reported.

  2. Mean Change from Baseline in Symptom Severity Measured by Visual Analog Scale at 30 days and 1 year [ Time Frame: 30 day follow up (15-45 days postop) and 1 year follow-up (9-15 months) ]
    Eight symptoms that are potentially related to the presence of a paraesophageal hernia will be assessed on a scale ranging from 0 to 10, with higher scores indicating more significant impact on quality of life. Symptoms include regurgitation, chest pain, abdominal pain, nausea, vomiting, postprandial pain, cardiovascular, and pulmonary symptoms. Each symptom will be reported separately.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18+
  • Able to participate in follow-up
  • Symptomatic paraesophageal hernia
  • Paraesophageal hernia is at least 5 centimeters in height on upper GI study or endoscopy
  • Elective laparoscopic paraesophageal hernia repair (must begin laparoscopic, but may convert to open surgery if needed)
  • Crura must be reapproximated at time of surgery

Exclusion Criteria:

  • Previous operations of the esophagus or stomach
  • Emergent operation for acute gastric volvulus
  • Paraesophageal hernia repair with concurrent bariatric procedure or procedure to reduce stomach volume
  • Placement of gastrostomy tube
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Clayton C Petro, MD 216-444-3501 PETROC@ccf.org
Contact: Samuel J Zolin, MD 216-308-2412 zolins@ccf.org

Locations
Layout table for location information
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clayton C Petro, MD    216-444-3501    PETROC@ccf.org   
Contact: Samuel J Zolin, MD    216-308-2412    zolins@ccf.org   
Principal Investigator: Clayton C Petro, MD         
Sponsors and Collaborators
The Cleveland Clinic
Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date November 13, 2020
Actual Study Start Date  ICMJE June 26, 2019
Estimated Primary Completion Date July 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019) 		Paraesophageal Hernia Recurrence [ Time Frame: 1 year ]
Either radiographic evidence of hernia recurrence on an upper GI study or need for reoperation secondary to paraesophageal hernia recurrence
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • Mean Change from Baseline in GERD-HRQL Scores at 30 days and 1 year [ Time Frame: 30 day follow up (15-45 days postop) and 1 year follow-up (9-15 months) ]
    The Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) is a 10-item instrument to quantify symptom severity in gastroesophageal reflux disease. Scores on individual items are summed and may range from 0 to 50, with higher scores indicating greater severity of symptoms and worse quality of life. Additionally, there is a question about global satisfaction with quality of life, which may be answered as "satisfied," "neutral," or "dissatisfied." The percentages of these categories will be reported.
  • Mean Change from Baseline in Symptom Severity Measured by Visual Analog Scale at 30 days and 1 year [ Time Frame: 30 day follow up (15-45 days postop) and 1 year follow-up (9-15 months) ]
    Eight symptoms that are potentially related to the presence of a paraesophageal hernia will be assessed on a scale ranging from 0 to 10, with higher scores indicating more significant impact on quality of life. Symptoms include regurgitation, chest pain, abdominal pain, nausea, vomiting, postprandial pain, cardiovascular, and pulmonary symptoms. Each symptom will be reported separately.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • Mean Change from Baseline in GERD-HRQL Scores at 30 days and 1 year [ Time Frame: 30 day follow up (15-45 days postop) and 1 year follow-up (9-15 months) ]
    The GERD-HRQL is a 10-item instrument to quantify symptom severity in gastroesophageal reflux disease.
  • Mean Change from Baseline in Symptom Severity Measured by Visual Analog Scale at 30 days and 1 year [ Time Frame: 30 day follow up (15-45 days postop) and 1 year follow-up (9-15 months) ]
    Symptoms include regurgitation, chest pain, abdominal pain, nausea, vomiting, postprandial pain, cardiovascular, and pulmonary symptoms
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair
Official Title  ICMJE Two-Armed Double-Blinded Registry-Based Randomized Control Trial Comparing Anterior Gastropexy to No Anterior Gastropexy for Paraesophageal Hernia Repair
Brief Summary This study evaluates the effect of anterior gastropexy (one or more sutures fixing the stomach to the inner abdominal wall) on improving durability of paraesophageal hernia repair. Half of participants will receive anterior gastropexy, while the other half will not. The hypothesis is that anterior gastropexy will help to prevent paraesophageal hernias from recurring.
Detailed Description

Paraesophageal hernias are hernias in which the stomach and/or other abdominal organs herniate through the diaphragm into the chest. This abnormal anatomy can lead to acid reflux, trouble swallowing, and shortness of breath, and can also be a risk factor for surgical emergencies involving the stomach. For these reasons, the Society of American Gastrointestinal and Endoscopic Surgeons has strongly recommended that all symptomatic paraesophageal hernias be repaired.

These repairs are technically challenging, and the best available evidence suggests that more than half of patients undergoing repair will have radiographic hernia recurrence at 5 years after surgery. There has been suggestion that use of anterior gastropexy - in which suture is used to affix the stomach to the anterior abdomen - may reduce recurrence rates. However, it is uncertain whether this data is reliable. While some surgeons use anterior gastropexy routinely because they believe it reduces recurrence, other surgeons do not use anterior gastropexy due to the concern that patients will have short-term pain at the suture site. This study aims to evaluate the effect of using anterior gastropexy on recurrence rates after paraesophageal hernia repair, compared to not using anterior gastropexy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This will be a double-blinded, registry-based, randomized control trial comparing anterior gastropexy to no anterior gastropexy in paraesophageal hernia repair. This will be a two-arm trial with intervention 1: intervention 2 and control allocation ratio of 1:1.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Participants will not be informed regarding the treatment that they received until they complete 1-year follow-up. Imaging will be reviewed at the end of the study period by surgeons who are blinded to treatment group.
Primary Purpose: Treatment
Condition  ICMJE
  • Paraesophageal Hernia
  • Hiatal Hernia Large
Intervention  ICMJE Procedure: Anterior Gastropexy
Two permanent sutures will be introduced into the abdomen and placed along the lesser curvature of the stomach. A suture passer will be used to grasp the ends of the sutures to externalize them at separate fascial punctures. At time of abdominal desufflation, the sutures will be tied and the incision closed per individual surgeon practice.
Study Arms  ICMJE
  • No Intervention: Intervention 1 (Control)
    No anterior gastropexy will be performed.
  • Experimental: Intervention 2 (Treatment)
    Anterior gastropexy will be performed.
    Intervention: Procedure: Anterior Gastropexy
Publications *
  • Ponsky J, Rosen M, Fanning A, Malm J. Anterior gastropexy may reduce the recurrence rate after laparoscopic paraesophageal hernia repair. Surg Endosc. 2003 Jul;17(7):1036-41. Epub 2003 Mar 28.
  • Oelschlager BK, Pellegrini CA, Hunter JG, Brunt ML, Soper NJ, Sheppard BC, Polissar NL, Neradilek MB, Mitsumori LM, Rohrmann CA, Swanstrom LL. Biologic prosthesis to prevent recurrence after laparoscopic paraesophageal hernia repair: long-term follow-up from a multicenter, prospective, randomized trial. J Am Coll Surg. 2011 Oct;213(4):461-8. doi: 10.1016/j.jamcollsurg.2011.05.017. Epub 2011 Jun 29. Erratum in: J Am Coll Surg. 2011 Dec;213(6):815.
  • Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20(2):130-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2019) 		240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2024
Estimated Primary Completion Date July 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18+
  • Able to participate in follow-up
  • Symptomatic paraesophageal hernia
  • Paraesophageal hernia is at least 5 centimeters in height on upper GI study or endoscopy
  • Elective laparoscopic paraesophageal hernia repair (must begin laparoscopic, but may convert to open surgery if needed)
  • Crura must be reapproximated at time of surgery

Exclusion Criteria:

  • Previous operations of the esophagus or stomach
  • Emergent operation for acute gastric volvulus
  • Paraesophageal hernia repair with concurrent bariatric procedure or procedure to reduce stomach volume
  • Placement of gastrostomy tube
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clayton C Petro, MD 216-444-3501 PETROC@ccf.org
Contact: Samuel J Zolin, MD 216-308-2412 zolins@ccf.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04007952
Other Study ID Numbers  ICMJE 19-616
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Clayton Petro, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Cleveland Clinic
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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