Quality of Life Results After Laparoscopic Fundoplication.

NCT04237038 | Completed DMC

• 1 other identifier: R-2013-601-8
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Quality of Life

Keywords

Laparoscopic fundoplication; Short gastric vessel

Outcome Measures

Primary Outcomes (3)

• Carlsson questionnaire

  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.

  five years

• Gastrointestinal Quality of Life Index (GIQLI) Gastrointestinal Quality of Life Index: GIQLI Gastrointestinal Quality of Life Index: GIQLI

  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

  five years

• Visick grading system

  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.

  five years

Study Arms (1)

laparoscopic Nissen fundoplication short gastric vessel divi

EXPERIMENTAL

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

Interventions

laparoscopic Nissen fundoplication short gastric vessel division PROCEDURE

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

laparoscopic Nissen fundoplication short gastric vessel divi

Eligibility Criteria

• Age: 22 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Related Publications (1)

• Prieto-Diaz-Chavez E, Medina-Chavez JL, Brizuela-Araujo CA, Gonzalez-Jimenez MA, Mellin-Landa TE, Gomez-Garcia TS, Gutierrez-Zamora J, Trujillo-Hernandez B, Millan-Guerrero R, Vasquez C. Patient satisfaction and quality of life following laparoscopic Nissen fundoplication. Rev Gastroenterol Mex. 2014 Apr-Jun;79(2):73-8. doi: 10.1016/j.rgmx.2013.11.003. Epub 2014 May 27. English, Spanish.

  PMID: 24878219 RESULT

Related Links

• http://dx.doi.org/10.1016/j.rgmx.2013.11.003

Study Officials

• EMILIO PRIETO DIAZ-CHAVEZ, PhD

  Universidad de Colima

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Masking Details: Assignment to the treatment or control group was provided with random numbers in sealed envelopes conducted by a physician of the outpatient clinic.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: January 22, 2020
• Study Start: February 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share