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Quality of Life Results After Laparoscopic Fundoplication.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04237038
Recruitment Status : Completed
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social

Brief Summary:
The present study focuses on determining aspects of satisfaction and quality of life of patients that underwent laparoscopic Nissen fundoplication with or without short gastric vessel division (SGVD) and long-term differences.

Condition or disease Intervention/treatment Phase
Quality of Life Procedure: laparoscopic Nissen fundoplication short gastric vessel division Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Intervention Model: Sequential Assignment
Intervention Model Description: A randomized clinical trial was conducted with patients submitted to laparoscopic Nissen fundoplication between February 2013 to december 2014 according to the guidelines established by the Mexican Consensus for the study of GERD.
Masking: None (Open Label)
Masking Description: Assignment to the treatment or control group was provided with random numbers in sealed envelopes conducted by a physician of the outpatient clinic.
Primary Purpose: Treatment
Official Title: Long-term Quality of Life Results After Laparoscopic Fundoplication With and Without Short Gastric Vessel Division in Gastroesophageal Reflux Management
Actual Study Start Date : February 1, 2013
Actual Primary Completion Date : November 1, 2014
Actual Study Completion Date : December 1, 2014

Arm Intervention/treatment
Experimental: laparoscopic Nissen fundoplication short gastric vessel divi
Randomized clinical trial conducted in forty patients submitted to short gastric vessel division (SGVD) forty patients without SGVD. Patients were evaluated with standarized questionnaires to measure the degree of satisfaction in relation to surgical procedure and to the quality of life.
Procedure: laparoscopic Nissen fundoplication short gastric vessel division
Randomized clinical trial conducted in forty patients submitted to SGVD and forty patients without SGVD. Patients were evaluated with standarized questionnaires to measure the degree of satisfaction in relation to surgical procedure and to the quality of life. A randomized clinical trial was conducted with 87 patients submitted to laparoscopic Nissen fundoplication between February 2013 to december 2014 according to the guidelines established by the Mexican Consensus for the study of Gastroesophageal reflux disease (GERD




Primary Outcome Measures :
  1. Carlsson questionnaire [ Time Frame: five years ]
    Carlsson questionnaire was applied to all the patients in order to measure reflux intensity. A total score between -7 and +18 points is obtained. Consider a score greater than or equal to 4 as positive for GERD.

  2. Gastrointestinal Quality of Life Index (GIQLI) Gastrointestinal Quality of Life Index: GIQLI Gastrointestinal Quality of Life Index: GIQLI [ Time Frame: five years ]
    evaluating quality of life in patients presenting with reflux disease.The maximum GIQLI in the international score is 144 and its worst value is 0

  3. Visick grading system [ Time Frame: five years ]
    Scale used to assess the assessment of patients regarding antireflux surgery, both openly and laparoscopically. The patient globally assesses the subjective outcome of the surgery: 1 = cured / asymptomatic, 2 = improved / scarce symptoms without the need for medical treatment, 3 = no significant changes / symptoms that require medical treatment, and 4 = worsened / great symptomatology.



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Ages Eligible for Study:   22 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) Patients who underwent surgery against Gastroesophageal Reflux with Nissen Fundoplication by Laparoscopic Pathway who were not divided into short gastric vessels during the procedure.
  • 2) Patients who underwent surgery against Gastroesophageal Reflux with Nissen Fundoplication by Laparoscopic Route who underwent a division of short gastric vessels during the procedure.
  • 3) Operated between October 2003 and November 2011 at the General Hospital of Zone # 1 "Dr. Leonel Ramírez García "of the IMSS Colima delegation.

Exclusion Criteria:

  • 1) Patients who underwent surgery against Gastroesophageal Reflux with Nissen Fundoplication by Laparoscopic Pathway who were not divided into short gastric vessels during the procedure.
  • 2) Patients who underwent surgery against Gastroesophageal Reflux with Nissen Fundoplication by Laparoscopic Route who underwent a division of short gastric vessels during the procedure.
  • 3) Operated between October 2003 and November 2011 at the General Hospital of Zone # 1 "Dr. Leonel Ramírez García "of the IMSS Colima delegation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237038


Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
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Study Director: EMILIO PRIETO DIAZ-CHAVEZ, PhD Universidad de Colima

Additional Information:
Publications of Results:
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Responsible Party: GONZALEZ-OJEDA ALEJANDRO, Clinical Professor, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT04237038    
Other Study ID Numbers: R-2013-601-8
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social:
Laparoscopic fundoplication
Short gastric vessel