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

NCT01139229 | Completed

• 1 other identifier: WCH20070901
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Esophageal Neoplasms; Surgical Stomas

Keywords

Esophagogastrostomy; Circular everted anastomosis; Side-side anastomosis; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• the incidence of anastomotic stricture

  the anastomotic stricture is defined as the diameter of the anastomotic orifice \<= 0.8 cm on esophagogram

  three months

Secondary Outcomes (3)

• The grades of dysphagia

  three months

• the grades of acid regurgitation

  three months

• the clinicopathological parameters in relation to postoperative complications

  three months

Study Arms (3)

HE group

OTHER

Other: hybrid everted esophagogastric anastomosis

HS group

OTHER

Other: the conventional hand-sewn anastomosis

SA group

OTHER

Other: a stapled anastomosis

Interventions

hybrid everted esophagogastric anastomosis OTHER

Also known as: no other names

HE group

the conventional hand-sewn anastomosis OTHER

Also known as: no other names

HS group

a stapled anastomosis OTHER

Also known as: no other names

SA group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• pathologically diagnosed esophageal neoplasms
• undergoing the Esophagogastrostomy

You may not qualify if:

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

Sponsors & Collaborators

• Sichuan University: lead

Related Publications (6)

• 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.

  PMID: 9296510 RESULT

• 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.

  PMID: 16269373 RESULT

• 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.

  PMID: 16791967 RESULT

• 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.

  PMID: 18210181 RESULT

• 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.

  PMID: 10595609 RESULT

• 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.

  PMID: 23381675 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Qi L Chen

  the Department of Cardiothoracic Surgery, Huaxi Hospital of Sichuan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 8, 2010
• Study Start: November 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: September 1, 2008
• Last Updated: June 8, 2010

Record last verified: 2010-03