NCT02855333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

July 13, 2016

Last Update Submit

August 3, 2016

Conditions

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

Keywords

Merendino procedureFeasibility, Safety and QoL of the Merendino procedure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Intraoperative complications

    up to 1 day after surgery

  • Postoperative complications

    up to 100 days after surgery

Study Arms (2)

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

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

Interventions

EORTC and QLQ-C30 / QLQ-OES24 questionnaireOTHER

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

Control Group (CON)Merendino Group (MER)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Baselland, Liestal

Liestal, Basel-Landschaft, 4410, Switzerland

Location

Related Publications (5)

  • Zapletal C, Lorenz D. Quality of life after surgical treatment of early Barrett's cancer: a prospective comparison of the Ivor-Lewis resection versus the modified Merendino resection. A statistical hint: reply. World J Surg. 2014 Nov;38(11):3034. doi: 10.1007/s00268-014-2723-8. No abstract available.

    PMID: 25189438BACKGROUND

  • Gotzky K, Jahne J. [Quality of life after operation for early Barrett's cancer: a prospective comparison of Ivor Lewis resection versus modified Merendino resection]. Chirurg. 2014 Sep;85(9):822. doi: 10.1007/s00104-014-2856-1. No abstract available. German.

    PMID: 25123190BACKGROUND

  • Mangano A, Lianos GD, Rausei S, Boni L, Dionigi G. Quality of life after surgical treatment of early Barrett's cancer: a prospective comparison of the Ivor-Lewis resection versus the modified Merendino resection. A statistical hint. World J Surg. 2014 Nov;38(11):3033. doi: 10.1007/s00268-014-2624-x. No abstract available.

    PMID: 24791672BACKGROUND

  • Zapletal Ch, Heesen Ch, Origer J, Pauthner M, Pech O, Ell Ch, Lorenz D. Quality of life after surgical treatment of early Barrett's cancer: a prospective comparison of the Ivor-Lewis resection versus the modified Merendino resection. World J Surg. 2014 Jun;38(6):1444-52. doi: 10.1007/s00268-013-2410-1.

    PMID: 24378548BACKGROUND

  • Holscher AH, Vallbohmer D, Gutschow C, Bollschweiler E. Reflux esophagitis, high-grade neoplasia, and early Barrett's carcinoma-what is the place of the Merendino procedure? Langenbecks Arch Surg. 2009 May;394(3):417-24. doi: 10.1007/s00423-008-0429-9. Epub 2008 Nov 7.

    PMID: 18989696BACKGROUND

Study Officials

  • Christoph A Maurer, MD, PhD

    Hirslanden

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

August 4, 2016

Study Start

May 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

August 4, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)