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NCT Number: NCT02372747

Comparison of Delta-Shaped and Billroth II After TLDG

To compare the safety and feasibility of Delta-shaped anastomosis and Billroth II anastomosis after totally laparoscopic distal gastrectomy for gastric cancer(TLDG).

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Methods: 78 consecutive patients who underwent TLDG in First Hospital of Jilin University between October 2012 and December 2014 were enrolled in this study . All patients were divided randomly into two groups:Delta-shaped anastomosis group (DS group) and Billroth II anastomosis group (B-II group), and the patients in DS group underwent Delta-shaped anastomosis after TLDG, and the patients in B-II group underwent Billroth-II anastomosis after TLDG.Outcome measures,resected margin,operative time,anastomosis time,number of stapler cartridges used,length of the incision,the time of first flatus and liquid diet,hospital stay and postoperative morbidity are compared between the two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • carcinoma located in the lower 1/3 of gastric body or antrum of stomach
  • diagnosed by endoscopy ,endoscopic ultrasonography and abdominal CT scan
  • diameter of the tumor <3cm
  • no pyloric obstruction

Exclusion criteria

  • diameter of the tumor ≥3cm
  • associated with obstruction, bleeding, emergency surgery or surgical intervention
  • tumor with extensive metastasis
  • patient had previously undergone gastrostomy

Treatment and study plan

Delta-shaped anastomosis

Procedure

The patients in DS group underwent Delta-shaped anastomosis after TLDG.

Billroth II anastomosis

Procedure

The patients in B-II group underwent Billroth-II anastomosis after TLDG.

Primary outcomes

  1. Stage distribution

    Time frame: up to 7 days after the operation

  2. Resected margin

    Time frame: up to 7 days after the operation

  3. Operative time

    Time frame: up to 7 days after the operation

  4. Anastomosis time

    Time frame: up to 7 days after the operation

  5. The number of stapler cartridges used

    Time frame: up to 7 days after the operation

  6. Median estimated blood loss

    Time frame: up to 7 days after the operation

  7. Red blood cell transfusion

    Time frame: up to 7 days after the operation

  8. Length of the incision

    Time frame: up to 7 days after the operation

Secondary outcomes

  1. Postoperative complication

    Time frame: up to 30 days after the operation

    Major complications includes anastomosis leakage and intrabdominal bleeding . Minor complications includes bile regurgitation,anastomotic stenosis and delayed gastric emptying.

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

Comparison of Delta-Shaped and Billroth II for Intracorporeal Anastomosis After Totally Laparoscopic Distal Gastrectomy for Gastric Cancer

Acronym: TLDG

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Feb 26, 2015
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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