Feasibility, Safety and QoL After Merendino Procedure (MER)

August 3, 2016 updated by: Kantonsspital Liestal

The Merendino Procedure for Benign or Early Malignant Lesions of the Distal Esophagus/Gastroesophageal Junction is Feasible, Safe and Provides Good QoL

The purpose of this study is to analyse retrospectively the early postoperative and functional outcome of patients (pts) after Merendino procedure for benign or early malignant lesions of the distal part of the esophagus or the gastroesophageal junction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Between 2004 and 2013, 14 pts had transhiatal resection of median 8 (6-10) cm of distal esophagus including the gastroesophageal junction. Locoregional lymphadenectomy was performed in all patients with (suspected) early adenocarcinoma. In case of vagus nerve resection, pyloromyectomy and cholecystectomy were done. A pediculated isoperistaltic jejunal segment of 15-18 cm length was interponed between esophageal stump and remaining stomach by end-to-side anastomoses. At least one postoperative contrast examination of the anastomoses was done in all pts. Quality of life was assessed by using the EORTC QLQ-OES18 survey, recording patients' general activity and condition and specific gastrointestinal symptoms.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Basel-Land
      • Liestal, Basel-Land, Switzerland, 4410
        • Kantonsspital Baselland, Liestal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients who underwent Merendino procedure between 08/2004 and 02/2013 at the Kantonal Hospital of Baselland, Liestal (Switzerland) were included into the Merendino (MER) group. Considering indication for surgery, age, ASA score, and co-morbidities, patients who underwent gastrectomy during the same period were matched for control (CON) group.

Description

Inclusion Criteria:

  • alive
  • MER or CON procedure
  • informed consent
  • CON patients were matched according to diagnosis, Age and ASA score

Exclusion Criteria:

  • withdrawal of informed consent
  • legal incapacity
  • limitations in mental state or medical condition precluding questioning (only QoL data)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Merendino Group (MER)
Patients who underwent merendino procedure for benign or early malignant lesions of the distal esophagus/gastroesophageal junction Perioperative data and EORTC and QLQ-C30 / QLQ-OES24 questionnaire
Other: EORTC and QLQ-C30 / QLQ-OES24 questionnaire
EORTC and QLQ-C30 / QLQ-OES24 questionnaire was sent to patients to asses QoL after MER or CON procedure
Control Group (CON)
Patients who underwent alternative surgery for benign or early malignant lesions of the distal esophagus/gastroesophageal junction Perioperative data and EORTC and QLQ-C30 / QLQ-OES24 questionnaire
Other: EORTC and QLQ-C30 / QLQ-OES24 questionnaire
EORTC and QLQ-C30 / QLQ-OES24 questionnaire was sent to patients to asses QoL after MER or CON procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (QoL)
Time Frame: up to 10 years after surgery
EORTC QLQ-C30 and QLQ-OES24 questionnaire (global health status item, functional and symptom scale items)
up to 10 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative complications
Time Frame: up to 1 day after surgery
Blood loss (ml), requirement for blood transfusion (units), operation time (min)
up to 1 day after surgery
Postoperative complications
Time Frame: up to 100 days after surgery
Morbidity (re-intervention rate, re-operation rate), in-hospital mortality
up to 100 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Liestal

Investigators

  • Study Director: Christoph A Maurer, MD, PhD, Hirslanden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 4, 2016

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KLiestal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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