Feasibility, Safety and QoL After Merendino Procedure

Completed

• Conditions: Benign or Early Malignant Lesion of the Distal Esophagus or Gastro-esophageal Junction Requiring Surgical Resection
• Interventions: Other: EORTC and QLQ-C30 / QLQ-OES24 questionnaire

• Registration Number: NCT02855333
• Lead Sponsor: Kantonsspital Liestal

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.

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2016-07-13
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-03
• Last Update Submitted: 2016-08-03
• Study First Posted: 2016-08-04
• Last Update Posted: 2016-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Merendino Group (MER)	EORTC and QLQ-C30 / QLQ-OES24 questionnaire	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
Control Group (CON)	EORTC and QLQ-C30 / QLQ-OES24 questionnaire	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kantonsspital Baselland, Liestal; 🇨🇭 Liestal, Basel-Land, Switzerland