Clinical trial NCT01139229: Hybrid-everted Versus Hand-sewn or Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture
Official title: Phase III Study of Hybrid-everted Versus Hand-sewn of Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Neoplasms
Surgical Stomas
Keywords: Esophagogastrostomy
Circular everted anastomosis
Side-side anastomosis
Randomized clinical trial
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2010-06-08
Enrollment: 144
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: the incidence of anastomotic stricture
timeFrame: three months
Secondary outcomes:
measure: The grades of dysphagia
timeFrame: three months
measure: the grades of acid regurgitation
timeFrame: three months
measure: the clinicopathological parameters in relation to postoperative complications
timeFrame: three months
Other outcomes:
Locations:
Study officials:
affiliation: the Department of Cardiothoracic Surgery, Huaxi Hospital of Sichuan University
name: Qi L Chen
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.