Skip to main content
OpenTrials
Completed

NCT Number: NCT02855333

Feasibility, Safety and QoL After Merendino Procedure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kantonsspital Baselland, Liestal

Liestal, Basel-Landschaft, 4410, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

EORTC and QLQ-C30 / QLQ-OES24 questionnaire

Other

EORTC and QLQ-C30 / QLQ-OES24 questionnaire was sent to patients to asses QoL after MER or CON procedure

Primary outcomes

  1. 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)

Secondary outcomes

  1. Intraoperative complications

    Time frame: up to 1 day after surgery

    Blood loss (ml), requirement for blood transfusion (units), operation time (min)

  2. Postoperative complications

    Time frame: up to 100 days after surgery

    Morbidity (re-intervention rate, re-operation rate), in-hospital mortality

Sponsors and collaborators

Lead sponsor

Kantonsspital Liestal

Other

Registry information

Official study title

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

Acronym: MER

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 4, 2016
Registry last updated
Aug 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.