Quality of Life Results After Laparoscopic Fundoplication.
Condition: Quality of Life
Study type: Interventional

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.
    

Detailed description: 
      The aim of our study was to identify the degree of satisfaction and the quality of life of
      patients that underwent laparoscopic Nissen total fundoplication with or without SGVD.

      Materials and methods. 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 GERD.12 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 in whom
      conversion to open surgery was performed. 2) Operated before October 2003 or after November
      2011.3) Patients whose data is not available for their location. Disposal criteria:1)
      Patients not reachable for any reason.2. Patients who do not wish to participate. 3. Patients
      with incomplete medical information for research.

      The patients were assigned into two groups: 43 patients that had SGVD and 44 patients in whom
      the short gastric vessels were left intact. Seven patients were lost during the follow-up,
      leaving 40 patients in the SGVD group and 40 in the group without SGVD. The mean follow-up
      time was 5±0,5 years (4 to 6 years) and the Nissen total fundoplication was the only surgical
      procedure performed by the authors. Complications, hospital stay, and surgical time
      (secondary aims) were identified in a blinded fashion. The time it took to return to daily
      activities, the degree of satisfaction measured, quality of life, and symptom persistence
      (primary aims) were identified through standardized questionnaires that were previously
      validated for that purpose. The level of satisfaction, quality of life of the postopera-tive
      patients, and surgical morbidity were evaluated through standardized and validated
      questionnaires elaborated for that purpose. The Carlsson questionnaire was applied to all the
      patients in order to measure reflux intensity; quality of life was studied postoperatively
      through the GIQLI (an adequate,valid,and useful instrument for evaluating quality of life in
      patients presenting with reflux disease)because it includes specific questions about
      digestive symp-toms and generic questions about physical,emotional,and social capacity.The
      questionnaire contains 36 items with an answer scale from0(the worst result) to 4(the best
      result).Global scores above 86 were regarded as a satisfactory effect, even in the presence
      of residual symptoms.Dysphagia was evaluated with the Dysphagia score,the Analog scale for
      dysphagia,and the Visick grading system.The questionnaire dealing with the level of
      satisfaction and quality of life was applied to each patient that had a minimum5-year
      postoperative period; it was applied verbally and the questions were asked by a researcher
      uninvolved in the surgical management.The level of satisfaction was evaluated nominally with
      the following questions:Would you accept being operated on again? Would you recommend the
      procedure to a friend or familymember? TheGIQLI was chosen because it is a validated
      questionnaire n Spanish.It consists of 36 questions divided in to 5 sections,with a specific
      part for digestive diseases.Scoring and the visual analog for dysphagia were measured through
      validated sco-ring scales,whereas the Visick scale was measured ordinally.

      Statistical analysis. A database was designed (Microsoft Excel) and the statistical analysis
      was done through the IBM SPSS Statistics ver. 21 (©copyright IBM Corporation) program. The
      comparative analysis of the groups was carried out under the principles of
      intention-to-treat. Descriptive statistics were used as mean, standard deviation and
      percentages. The comparison of averages between groups was performed using Student t or
      Mann-Whitney U tests (for equal variances or different respectively). The percentage
      comparison was made with Chi-square or Fisher exact tests. While the pairwise comparison of
      ordinal variables Wilcoxon test was used. In all statistical test, a confidence interval of
      95% was used. Statistical significance was set at a p<0,05.
    

Intervention name(s): laparoscopic Nissen fundoplication short gastric vessel division
Intervention type(s): Procedure
Intervention description(s): 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
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)
Primary purpose: Treatment
Keywords: Laparoscopic fundoplication; Short gastric vessel