Feasibility, Safety and QoL After Merendino Procedure

NCT ID: NCT02855333

Last Updated: 2016-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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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

EORTC and QLQ-C30 / QLQ-OES24 questionnaire

Intervention Type OTHER

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

EORTC and QLQ-C30 / QLQ-OES24 questionnaire

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Liestal

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph A Maurer, MD, PhD

Role: STUDY_DIRECTOR

Hirslanden

Locations

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Kantonsspital Baselland, Liestal

Liestal, Basel-Landschaft, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 25189438 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25123190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24791672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24378548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18989696 (View on PubMed)

Other Identifiers

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KLiestal

Identifier Type: -

Identifier Source: org_study_id

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