Feasibility, Safety and QoL After Merendino Procedure

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Benign or Early Malignant Lesion of the Distal Esophagus or Gastro-esophageal Junction Requiring Surgical Resection

Intervention / Treatment
-----------------
* Other: EORTC and QLQ-C30 / QLQ-OES24 questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Merendino Group (MER)<br>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<br>* EORTC and QLQ-C30 / QLQ-OES24 questionnaire was sent to patients to asses QoL after MER or CON procedure<br>|
| Control Group (CON)<br>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<br>* EORTC and QLQ-C30 / QLQ-OES24 questionnaire was sent to patients to asses QoL after MER or CON procedure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Merendino procedure, Feasibility, Safety and QoL of the Merendino procedure