Heart and Blood Diseases

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Neoplasms

Aneurysm

Liver Cirrhosis

Abdominal Neoplasms

Fistula

Intestinal Obstruction

Intestinal Fistula

Vascular Diseases

Pathological Conditions, Anatomical

Intestinal Diseases

Gastrointestinal Diseases

Digestive System Fistula

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Dexmedetomidine

Propofol

Benzocaine

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Tannic Acid

Group 1:when the patient can be roused after major abdominal surgery ，we will inject dexmedetomidine at 1μg/kg in 10 minutes as a loading dose, followed by a continuous infusion at 0.3μg/kg/h for 6 to 24hours.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.

Group 2 :when the patient can be roused after major abdominal surgery ，we will inject propofol at 0.5mg/kg as a loading dose, followed by a continuous infusion at 0.5mg/kg.h for 6 to 24hours.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores

dexmedetomidine: IV (in the vein)at 1μg/kg in 10 minutes as a loading dose, followed by a continuous infusion at 0.3μg/kg/h.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.

dexmedetomidine

propofol: IV (in the vein)at 0.5mg/kg as a loading dose, followed by a continuous infusion at 0.5mg/kg/h.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.

propofol

mingyin chen, MD

minying chen, MD

The alpha2 agonist dexmedetomidine is a new sedative agent combined with the analgesic qualities and lack of respiratory depression. Patients sedated with dexmedetomidine could be easily roused, these advances shows dexmedetomidine may be a effective and safe sedative agent. But some studies showed some adversely effects of dexmedetomidine on haemodynamics (such as bradycardia, hypotension), the investigators want to further research the effects of dexmedetomidine on haemodynamics, such as Cardiac Output (CO), Systemic Venous Resistance Index(SVRI), and so on. Propofol is widely used sedative agent in ICU, it also has adversely effects like bradycardia and hypotension, so the investigators want to compare the effect of dexmedetomidine with propofol on haemodynamics after major abdominal surgery. Expect to further research the mechanism of haemodynamics of dexmedetomidine.

When the patients can be roused, they will first receive analgesia with bolus of fentanyl 0.03mg, followed by a continuous infusion at a ﬁxed dose of 0.3μg/kg/h during study period. Then patients will be randomly divided into two groups (Dexmedetomidine and Propofol). All of them will receive hemodynamic monitoring through "Vigileo"(Edwards Lifesciences) and cardiogram monitor. The study will continue for 6-24 hours.

Comparison the Hemodynamics Effects Between Dexmedetomidine and Propofol in Major Abdominal Surgical Patients

First Affiliated Hospital, Sun Yat-Sen University

Skin and Connective Tissue Diseases

Rare Diseases

Hernia

Hernia, Ventral

Peritoneal Neoplasms

Fibromatosis, Aggressive

Fibromatosis, Abdominal

Fibroma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Hernia, Abdominal

Desmoid Tumor

Abdominal wall reconstruction with Strattice Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively

Abdominal wall reconstruction with XenMatrix Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively

Abdominal wall reconstruction using Strattice

Abdominal wall reconstruction with Strattice

Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)

Assess pain intensity at last office visit preoperatively

Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)

Assess pain interference at last office visit preoperatively

Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)

Assess physical functioning at last office visit preoperatively

Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)

Assess patient quality of life at last office visit preoperatively

Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey

Assess patient pain intensity postoperatively

Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey

Assess pain interference postoperatively

Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey

Assess physical functioning postoperatively

Assess quality of life at 1 year postoperatively using the HerQLes survey

Assess quality of life postoperatively

Assess hernia recurrence at 30 days postoperatively

Assess bulge at 30 days postoperatively

Assess Surgical Site Occurrences at 30 days

Assess Surgical Site Occurrences at 30 days postoperatively

Assess hernia recurrence at 1 year postoperatively

Assess bulge at 1 year postoperatively

Assess Surgical Site Occurrences at 1 year postoperatively

Assess overall complications at 30 days postoperatively

Assess overall complications at 1 year postoperatively

Abdominal wall reconstruction with XenMatrix

Strattice

XenMatrix

Benjamin Sarac, MD

Jeffrey E Janis, MD

Daniel S Eiferman, MD

Vimal Narula, MD

The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two meshes are derived from pig skin from which cells have been removed and which have been sterilized. The two meshes are made by two different companies using different processes.

This is a prospective, randomized-controlled trial comparing two porcine acellular matrices in abdominal wall reconstruction. It is single-blind (patients are blinded to the type of mesh used while surgeons are not).

Our goals in this study are:

1. PRIMARY OUTCOME: To compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days and 1 year postoperatively
2. SECONDARY OUTCOMES

i. To compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days and 1 year postoperatively

1. Infection
2. Seroma
3. Hematoma
4. Wound dehiscence
5. Skin necrosis
6. Formation of enterocutaneous fistula
7. Mesh infection ii. To compare the hernia recurrence rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iii. To compare the bulge rate between XenMatrix and Strattice at 30 days and 1 year postoperatively iv. To compare to changes in patient pain, physical functioning and quality of life after hernia repair between XenMatrix and Strattice, preoperatively, and at 1 year postoperatively A. Pain assessment: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity survey, PROMIS Pain Interference survey B. Physical functioning assessment: PROMIS Physical Function C. Quality of life assessment: Hernia-Related Quality-of-Life (HerQLes) survey

RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction

Prospective Trial Comparing the Performance Profiles of Two Non-Cross-Linked Porcine Dermal Matrices in Abdominal Wall Reconstruction

Compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 1 year postoperatively

Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include:

1. Infection
2. Seroma
3. Hematoma
4. Wound dehiscence
5. Skin necrosis
6. Formation of enterocutaneous fistula
7. Mesh infection

Compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days postoperatively

Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days postoperatively. These include:

1. Infection
2. Seroma
3. Hematoma
4. Wound dehiscence
5. Skin necrosis
6. Formation of enterocutaneous fistula
7. Mesh infection

Measure patient pain intensity of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Pain Intensity survey

Measure patient pain interference of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Pain Interference survey

Measure patient pain intensity of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Pain Intensity survey

Measure patient pain interference of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Pain Interference survey

Measure physical functioning of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Physical Function survey

Measure physical functioning of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Physical Function survey

Measure patient quality of life of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the HerQLes survey (Hernia Related Quality of Life survey)

Measure patient quality of life of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the HerQLes survey (Hernia Related Quality of Life survey)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison the Hemodynamics Effects Between Dexmedetomidine and Propofol in Major Abdominal Surgical Patients	NCT01669044	Abdominal Tumor Intestinal Obst... Cirrhosis Intestinal Fist... Aneurism	dexmedetomidine propofol	18 Years -	First Affiliated Hospital, Sun Yat-Sen University
RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction	NCT02228889	Hernia, Ventral Intestinal Fist... Fibromatosis, A...	Abdominal wall ... Assess pain int... Assess pain int... Assess physical... Assess patient ... Assess patient ... Assess pain int... Assess physical... Assess quality ... Assess hernia r... Assess bulge at... Assess Surgical... Assess hernia r... Assess bulge at... Assess Surgical... Assess overall ... Assess overall ... Abdominal wall ... Strattice XenMatrix	18 Years - 99 Years	Ohio State University
RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction	NCT02228889	Hernia, Ventral Intestinal Fist... Fibromatosis, A...	Abdominal wall ... Assess pain int... Assess pain int... Assess physical... Assess patient ... Assess patient ... Assess pain int... Assess physical... Assess quality ... Assess hernia r... Assess bulge at... Assess Surgical... Assess hernia r... Assess bulge at... Assess Surgical... Assess overall ... Assess overall ... Abdominal wall ... Strattice XenMatrix	18 Years - 99 Years	Ohio State University
Comparison the Hemodynamics Effects Between Dexmedetomidine and Propofol in Major Abdominal Surgical Patients	NCT01669044	Abdominal Tumor Intestinal Obst... Cirrhosis Intestinal Fist... Aneurism	dexmedetomidine propofol	18 Years -	First Affiliated Hospital, Sun Yat-Sen University

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