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This study is being conducted to compare surgical and patient outcomes across stapled (Group II) versus hand-sutured (Group I) groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stapling | Experimental |
| |
| Suturing | Active Comparator | 4 layered hand-sutured anastomosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advant 55 Linear Cutter/Stapler | Procedure | Advant 55 Linear Cutter/Stapler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Surgery (Skin Open to Skin Close) | Day 1 | |
| Time of Anastomosis | Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I) | |
| Return to Bowel Activity | Number of days post-surgery to appearance of peristaltic movement |
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Inclusion Criteria:a.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Govt General Hospital and Madras Medical College | Chennai | 600003 | India | |||
| Indira Gandhi Government Medical College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17636751 | Background | Choy PY, Bissett IP, Docherty JG, Parry BR, Merrie AE. Stapled versus handsewn methods for ileocolic anastomoses. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004320. doi: 10.1002/14651858.CD004320.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stapling | |
| FG001 | Suturing | 4 layered hand-sutured anastomosis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Suturing |
| Procedure |
Suturing |
|
| Nagpur |
| 440018 |
| India |
| GB Pant Hospital | New Delhi | 110002 | India |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stapling | |
| BG001 | Suturing | 4 layered hand-sutured anastomosis |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time of Surgery (Skin Open to Skin Close) | Intent-to-Treat | Posted | Mean | Standard Error | minutes | Day 1 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Time of Anastomosis | Posted | Mean | Standard Error | minutes | Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I) |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Return to Bowel Activity | Posted | Mean | Standard Error | days | Number of days post-surgery to appearance of peristaltic movement |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stapling | 9 | 142 | 26 | 142 | |||
| EG001 | Suturing | 4 layered hand-sutured anastomosis | 8 | 138 | 21 | 138 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Intestinal obstruction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Wound sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Anastomotic fistula | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Anastomotic leak | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Failure to anastomose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Post procedural hemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hemiplegia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Postictal paralysis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheryl Helsinger/Clinical Affairs Director | Ethicon Endo Surgery, Inc | 513-337-3079 | shelsing@its.jnj.com |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| >=65 years |
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| Male |
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