Hybrid-everted Versus Hand-sewn or Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture

NCT ID: NCT01139229

Last Updated: 2010-06-08

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

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-09-30

Brief Summary

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The investigators improved the hybrid everted esophagogastrostomy and expected to prevent the incidence of anastomotic stricture. The purpose of this study is to determine the clinical value of this kind of operation type, and analyzes the clinicopathological factors causing the postoperative complications.

Detailed Description

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This randomized clinical trial compared a hybrid everted esophagogastric anastomosis with conventional hand-sewn or stapled esophagogastrostomy for prevention of anastomotic stricture. The patients were completely randomized to receive either a hybrid everted esophagogastric anastomosis (HE group), or the conventional hand-sewn (HS group), or a stapled (SA group) anastomosis, after the removal of esophageal tumor. The primary outcome measured the incidence of anastomotic stricture at 3 months after the operation (defined as the diameter of the anastomotic orifice \<= 0.8 cm on esophagogram), analyzed by intention-to-treat.

Conditions

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Esophageal Neoplasms Surgical Stomas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HE group

Group Type OTHER

hybrid everted esophagogastric anastomosis

Intervention Type OTHER

HS group

Group Type OTHER

the conventional hand-sewn anastomosis

Intervention Type OTHER

SA group

Group Type OTHER

a stapled anastomosis

Intervention Type OTHER

Interventions

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hybrid everted esophagogastric anastomosis

Intervention Type OTHER

the conventional hand-sewn anastomosis

Intervention Type OTHER

a stapled anastomosis

Intervention Type OTHER

Other Intervention Names

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no other names no other names no other names

Eligibility Criteria

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Inclusion Criteria

* pathologically diagnosed esophageal neoplasms
* undergoing the Esophagogastrostomy

Exclusion Criteria

* the patients with previous the upper gastrointestinal tract surgery
* the esophageal carcinoma patients with previous neoadjuvant chemotherapy
* the esophageal carcinoma complicated other esophagogastric diseases
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan University

OTHER

Sponsor Role lead

Responsible Party

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Department of Thoracic and Cardiovascular Surgery, West China Hospital of Sichuan University

Principal Investigators

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Qi L Chen

Role: STUDY_CHAIR

the Department of Cardiothoracic Surgery, Huaxi Hospital of Sichuan University

References

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Law S, Fok M, Chu KM, Wong J. Comparison of hand-sewn and stapled esophagogastric anastomosis after esophageal resection for cancer: a prospective randomized controlled trial. Ann Surg. 1997 Aug;226(2):169-73. doi: 10.1097/00000658-199708000-00008.

Reference Type RESULT
PMID: 9296510 (View on PubMed)

Behzadi A, Nichols FC, Cassivi SD, Deschamps C, Allen MS, Pairolero PC. Esophagogastrectomy: the influence of stapled versus hand-sewn anastomosis on outcome. J Gastrointest Surg. 2005 Nov;9(8):1031-40; discussion 1040-2. doi: 10.1016/j.gassur.2005.06.025.

Reference Type RESULT
PMID: 16269373 (View on PubMed)

Moher D, Schulz KF, Altman D; CONSORT Group. The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001. Explore (NY). 2005 Jan;1(1):40-5. doi: 10.1016/j.explore.2004.11.001.

Reference Type RESULT
PMID: 16791967 (View on PubMed)

Zhu ZJ, Zhao YF, Chen LQ, Hu Y, Liu LX, Wang Y, Kou YL. Clinical application of layered anastomosis during esophagogastrostomy. World J Surg. 2008 Apr;32(4):583-8. doi: 10.1007/s00268-007-9396-5.

Reference Type RESULT
PMID: 18210181 (View on PubMed)

Laterza E, de' Manzoni G, Veraldi GF, Guglielmi A, Tedesco P, Cordiano C. Manual compared with mechanical cervical oesophagogastric anastomosis: a randomised trial. Eur J Surg. 1999 Nov;165(11):1051-4. doi: 10.1080/110241599750007883.

Reference Type RESULT
PMID: 10595609 (View on PubMed)

Wang WP, Gao Q, Wang KN, Shi H, Chen LQ. A prospective randomized controlled trial of semi-mechanical versus hand-sewn or circular stapled esophagogastrostomy for prevention of anastomotic stricture. World J Surg. 2013 May;37(5):1043-50. doi: 10.1007/s00268-013-1932-x.

Reference Type DERIVED
PMID: 23381675 (View on PubMed)

Other Identifiers

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WCH20070901

Identifier Type: -

Identifier Source: org_study_id

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