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Trial Comparing Side-to-Side Stapled and Hand-sewn Esophagogastric Anastomosis in Neck

This study has been completed.
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00497549
First received: July 5, 2007
Last updated: May 9, 2011
Last verified: April 2011
  Purpose

Carcinoma esophagus is a common cause of dysphagia. Once dysphagia occurs, a majority of the tumours are advanced. Most of them would require some form of treatments for control of dysphagia and to improve the quality of life. Surgery is the only hope for cure. It requires complete removal of the esophagus. After removal of the esophagus, the stomach can be used as a substitute for the esophagus. Anastomosis can be done in the neck either by a hand-sewn or by a stapled anastomosis. The anastomotic leak rates reported in studies comparing hand-sewn with stapled anastomosis are variable. Many non-randomized studies have reported leak rate as low as 5% with stapled technique. However, the stricture rate is higher in the stapled group. There is no randomized study comparing hand-sewn anastomosis with side-to-side stapled anastomosis. Hence, the investigators planned a randomized trial comparing the anastomotic sequelae after hand-sewn anastomosis with stapled anastomosis in the neck.


Condition Intervention
Esophageal Cancer
Procedure: side-to-side stapled
Procedure: hand sewn

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial Comparing Side to Side Stapled and Hand Sewn Esophagogastric Anastomosis in the Neck

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Anastomotic leakage defined as a radiological defect at the anastomotic site or leakage of swallowed fluid out of the drain site or cervical wound. [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
    It was defined as a radiological defect at the anastomotic site or leakage of swallowed fluid out of the drain site or cervical wound


Enrollment: 174
Study Start Date: July 2004
Study Completion Date: December 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
A proper site on the anterior wall of stomach away from the stapled line approximately 2 cm below the highest point of the gastric conduit will be anastamosed to esophagus Posterior interrupted seromuscular sutures will be taken with 3-0 silk. The stomach will then be opened transversely (2.5 to 3 cm long). Interrupted stitches with full thickness of the stomach and esophagus will be placed to achieve mucosa to mucosa approximation. A 16F nasogastric tube will then be placed across the anastomosis into the intrathoracic stomach. The anterior wall of the anastomosis will be completed in a manner similar to posterior wall.
Procedure: hand sewn
A proper site on the anterior wall of stomach away from the stapled line approximately 2 cm below the highest point of the gastric conduit will be anastamosed to esophagus Posterior interrupted seromuscular sutures will be taken with 3-0 silk. The stomach will then be opened transversely (2.5 to 3 cm long). Interrupted stitches with full thickness of the stomach and esophagus will be placed to achieve mucosa to mucosa approximation. A 16F nasogastric tube will then be placed across the anastomosis into the intrathoracic stomach. The anterior wall of the anastomosis will be completed in a manner similar to posterior wall.
Active Comparator: 2
5 cm of the mobilized stomach will be placed in the neck. Three interrupted sutures will be taken between the posterior wall of esophagus and anterior wall of stomach. A 1.5 cm gastrotomy will be made. Two stay sutures will then be taken, one at the anterior corner of esophagus and another between posterior corner of esophagus and the middle of the gastrotomy. The stapler device (Endopath, EZ45) will be introduced.The staple cartridge will then be rotated so that the posterior wall of the esophagus and the anterior wall of the stomach will align in a parallel manner and fire the stapler. A 16F nasogastric tube will be placed across the anastomosis and the anterior edges of the gastrotomy and open esophagus will be approximated with interrupted 3-0 silk.
Procedure: side-to-side stapled
5 cm of the mobilized stomach will be placed in the neck. Three interrupted sutures will be taken between the posterior wall of esophagus and anterior wall of stomach. A 1.5 cm gastrotomy will be made. Two stay sutures will then be taken, one at the anterior corner of esophagus and another between posterior corner of esophagus and the middle of the gastrotomy. The stapler device (Endopath, EZ45) will be introduced.The staple cartridge will then be rotated so that the posterior wall of the esophagus and the anterior wall of the stomach will align in a parallel manner and fire the stapler. A 16F nasogastric tube will be placed across the anastomosis and the anterior edges of the gastrotomy and open esophagus will be approximated with interrupted 3-0 silk.
Other Name: stapled

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Any patient with resectable carcinoma of the mid or lower thoracic esophagus and gastroesophageal junction
  2. Benign esophageal lesion where esophageal resection was beneficial and feasible

Exclusion Criteria:

  1. Patients who had upper thoracic or cervical esophageal carcinoma
  2. Irresectable lesions (T4/M1)
  3. Prior gastric surgery
  4. Poor performance status
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497549

Locations
India
All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Study Director: Tushar K Chattopadhyay, MS Deptt. GI Surgery, All India Institute of Medical sciences, New Delhi, India
Principal Investigator: Sundeep S Saluja, MS, MCh Deptt. GI Surgery, All India Institute of Medical sciences, New Delhi, India
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sundeep Singh Saluja, Department of G I Surgery, AIIMS
ClinicalTrials.gov Identifier: NCT00497549     History of Changes
Other Study ID Numbers: GIS1/2004
Study First Received: July 5, 2007
Last Updated: May 9, 2011
Health Authority: India: Ministry of Health

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Esophagectomy
hand sewn anastomosis
side-to-side stapled

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 25, 2014