Pre-pectoral immediate tissue expander breast reconstruction with complete AlloDerm® coverage to reinforce breast tissues.

Postoperative Pain

Postoperative Nausea and Vomiting

Quality of Life

Breast Cancer

Breast Prosthesis; Pain

All participants in the study will undergo bilateral mastectomy followed by Immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage.

Pre-pectoral Tissue Expander

The Johns Hopkins University

Pre-pectoral AlloDerm® to Reinforce Tissues in Tissue Expander Breast Reconstruction

The Use of Complete AlloDerm® Coverage in Two-stage Tissue Expansion and Implant Placement in the Subcutaneous (Pre-pectoral) Plane: a Prospective Pilot

Postoperative static pain scores with standard deviations from VAS will be measured on post-operative (after mastectomy and tissue expander placement) at Day 1

Postoperative dynamic pain scores with standard deviations from VAS will be measured on post-operative (after mastectomy and tissue expander placement) Day 1, Day 2, Day 3, and Day 7, before the initiation of tissue expander expansion, and in post-operative Day 30, and Day 60 following initiation of tissue expander expansion.

Postoperative static pain scores with standard deviations from VAS will be measured on post-operative (after mastectomy and tissue expander placement at Day 2, Day 3, and Day 7, before the initiation of tissue expander expansion, and in post-operative Day 30, and Day 60 following initiation of tissue expander expansion.

postoperative static pain scores with standard deviations from BPI-SF, will be measured on post-operative (after mastectomy and tissue expander placement) Day 1, Day 2, Day 3, and Day 7 before the initiation of tissue expander expansion, and in post-operative Day 30, and Day 60 following initiation of tissue expander expansion.

Evaluation of level of opioids (type of opioids and dosage) which the patient required to alleviate the pain related to the insertion and expansion of tissue expander. Relevant information will be assessed by the patients' charts (when inpatient) and by patients' reports to study members (as an outpatient) on Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after mastectomy and tissue expander placement.

Evaluation of number of participants who report postoperative vomiting according to the PONV Intensity Scale at Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after mastectomy and tissue expander placement.

Evaluation of number of participants who report postoperative nausea to either according the PONV Intensity Scale at Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after mastectomy and tissue expander placement.

Postoperative short-term changes in Quality of Life scores by using the Breast-Q questionnaire scores, on Day 30 after mastectomy and tissue expander placement.

Preoperative and postoperative (Day 30 after mastectomy and tissue expander placement) Quality of Life scores will be assessed by using the Breast-Q questionnaire scores. Changes in Quality of Life Scores will be assessed by subtracting preoperative score from the one recorded postoperative.

Postoperative short-term changes in Quality of Life scores by using the SF-36 Health Survey, after mastectomy and tissue expander placement on post-operative Day 7, and Day 30.

Preoperative and postoperative (Day 7, 30 after mastectomy and tissue expander placement) Quality of Life scores will be assessed by using the SF-36 Health Survey. Changes in Quality of Life Scores will be assessed by subtracting preoperative score from the ones recorded postoperative.

Postoperative complication rates will be assessed by patients' charts at Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after mastectomy and tissue expander placement. Number and characteristics of complications will be recorded.

Evaluation of level of opioids (type of opioids and dosage) which the patient required to alleviate the pain related to final breast reconstruction with permanent implant. Relevant information will be assessed by the patients' charts (when inpatient) and by patients' reports to study members (as an outpatient) on Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after final reconstruction with permanent implant.

Evaluation of number of participants who report postoperative vomiting according to the PONV Intensity Scale at Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after final breast reconstruction with permanent implant.

Evaluation of number of participants who report postoperative nausea according to the PONV Intensity Scale at Day 1, Day 2, Day 3, Day, 7, Day 30, and Day 60 after final breast reconstruction with permanent implant

Postoperative short-term changes in Quality of Life scores by using the Breast-Q questionnaire scores, on Day 30, and Day 60 after final breast reconstruction with permanent implant.

Preoperative, postoperative after mastectomy and tissue expander placement and postoperative after final breast reconstruction Quality of Life scores will be assessed by using the Breast-Q questionnaire scores. Changes in Quality of Life Scores will be assessed by subtracting the most recent score from the previous one, and the most recent from the very first one.

Postoperative short-term changes in Quality of Life scores by using the SF-36 Health Survey, after final breast reconstruction at post-operative Day 7, Day 30, and Day 60.

Preoperative, postoperative after mastectomy and tissue expander placement and postoperative after final breast reconstruction Quality of Life scores will be assessed by using the SF-36 Health Survey. Changes in Quality of Life Scores will be assessed by subtracting the most recent score from the previous one, and the most recent from the very first one.

Postoperative complication rates will be assessed by patients' charts at Day 1, Day 2, Day 3, Day 7, Day 30, and Day 60 after final breast reconstruction with permanent implant. Number and characteristics of complications will be recorded.

Postoperative rates of breast animation deformity will be assessed at Day 7, Day 30, and Day 60 after final reconstruction with permanent implant, using the Spear 4-point grading system. Participants will then be imaged using VECTRA® XT 3D digital imaging technology ("CANFIELD Scientific, Inc.") on Day 60. Differences in breast volume, surface area, shape, size, contour, and symmetry will be evaluated using the "VECTRA® XT" Analysis Module software

Hospital Length of Stay in days after final reconstruction with permanent implant will be assessed and recorder by reviewing patients' chart

Postoperative static pain scores with standard deviations from VAS will be measured on post-operative at Day 1, Day 2, Day 3, and Day 7, Day 30, and Day 60 following final breast reconstruction.

Postoperative dynamic pain scores with standard deviations from VAS will be measured on post-operative at Day 1, Day 2, Day3, and Day 7, Day 30, and Day 60 following final breast reconstruction.

Postoperative static pain scores from BPI-SF will be measured on post-operative at Day 1, Day 2, Day3, and Day 7, Day 30, and Day 60 following final breast reconstruction.

At the moment, there is no plan to share Individual Participant Data (IPD)

Johns Hopkins University

Critical Illness

Will place device on admission to SICU. Measure bowel sounds and await bowel function

AEGIS (Automated Evaluation of Gastrointestinal Symptoms)

Cedars-Sinai Medical Center

Computer-Aided, Non-Invasive, Acoustic Gastrointestinal Surveillance (AGIS) in ICU Patients

Matthew Bloom

Assistant Professor of Surgery

University of California, Los Angeles

Protein 1.5 gm/kg/day, energy (kcal) 30-40/day, B complex vitamins daily. Pasteurized Bovine colostrum as a freeze dried powder (20 gm thrice a day) for 4 weeks.
+ Antibiotics + Diuretics +Terlipressin for HRS + acid suppression for prophylaxis against gastrointestinal hemorrhage + EVL for variceal bleed +drugs for HE if indicated

Protein 1.5 gm/kg/day, energy (kcal) 30-40/day, B complex vitamins daily. Placebo (Pasteurised Milk Powder) 20 gms thrice a day for 4 weeks
+ Antibiotics + Diuretics + drugs for HE + Terlipressin for HRS + acid suppression for prophylaxis against gastrointestinal hemorrhage + EVL for variceal bleed + if indicated.

Alcoholic Hepatitis

Bovine Colostrum

Placebo

Department of Gastroenterology, D.M.C. and Hospital

Comparison of Bovine Colostrum Versus Placebo in Treatment of Severe Alcoholic Hepatitis: A Randomized Double Blind Controlled Trial

Change in mDF levels will be measured at baseline and after 30 days of treatment

Change in Endotoxin levels will be measured at baseline and after 4 weeks of treatment

Change in Cytokines levels will be measured at baseline and after 30 days of treatment

Number of episodes of sepsis (bacteremia, Pneumonia, SBP, Cellulitis, UTI)

Prof. Sandeep S Sidhu

Prof. Sandeep Singh Sidhu

Dayanand Medical College and Hospital

The study population will consist of patients who come to the emergency room with acute abdominal pain and are found to have acute appendicitis on the basis of clinical evaluation and CT of the abdomen/pelvis.

SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy

SILS Appendectomy

Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix

Conventional Laparoscopic Appendectomy

Total

Sex: Female, Male

Region of Enrollment

Mean pain score during 12 hours post-surgery, assessed by the ward nurse as needed, but at least every 4 hours, and documented in the patient's chart. Patients were asked to rate their pain on a scale of 0 to 10, with 10 being the most severe pain imaginable and 0 being no pain at all.

Pain After Surgery

The amount of time to perform the operation from skin-incision to application of the dressing. This time is routinely charted by the circulating nurse in the operating room.

Operative Time

Patients requiring use of additional incisions and/or trocars, or the need to perform an open procedure.

Procedures Requiring Conversion to Open or Additional Port

Number of participants who required intervention (suture or stapled repair, use of hemostatic agents) for injury to the intestines, colon, omentum, vasculature, or pelvic organs during the dissection.

Visceral or Vascular Injury

Number of calendar days the participant was hospitalized.

Length of Stay

Number of participants who required additional antibiotics, prescribed beyond the perioperative antibiotics given for acute appendicitis, for the purpose or treating a wound cellulitis.

Wound Infection

Number of participants who required reoperation, readmission, or percutaneous drainage of a deep (organ space) infection within 6 months of surgery. All intra-abdominal abscesses were classified as deep space infections.

Deep Space Infection

Number of participants who experienced un-inflamed fluid collection under the skin incision > 1cm in diameter identified within 6 months of surgery.

Wound Seroma

Number of calendar days between participants' discharge from the hospital and the first day back at work.

Time to Return to Work

Number of participants readmitted to the hospital within 30 days of surgery

Readmission Within 30 Days.

After a minimum of 6 months, a Body-Image Questionnaire was sent to participants. The questionnaire has 5 questions, with answers ranging from 1 (Extremely) to 4 (Not at all); lower scores indicate worse satisfaction with and perception of bodily appearance.
Are you less satisfied with our body since the operation? Do you think the operation has damaged your body? Do you feel less attractive as a results of your operation? Do you feel less feminine or masculine as a result of your operation? Is it difficult to look at yourself naked?

Body Image Score at 6 Months

The Cosmetic Appearance Scale assessed the degree of satisfaction with the physical appearance of the abdomen (and its scars) using a visual analogue scale. Numeric scores were obtained by measuring the horizontal distance from the low end of the scale to the marking, and then normalized on a scale of 0-20 points. Higher scores indicate a higher degree of satisfaction.
Since your operation, how would you describe the overall appearance of your abdomen? (Revolting; Beautiful) Since your operation, how would you describe your incisional scars? (Revolting; Beautiful) How satisfied are you with your incisional scars? (Very unsatisfied; Very satisfied) How much discomfort do your incisional scars cause? (Severe, daily pain; No pain at all) Can you score your own incisional scar? (Worst possible scar; Best possible scar)

Satisfaction With Physical Appearance of Abdomen and Scars at 6 Months.

Short-term Follow-up (Post Operative)

Long-term Follow-up (After 6 Months)

Jonathan T. Carter, MD, FACS

Appendicitis

Use of SILSPort to perform laparoscopic appendectomy

SILS appendectomy

conventional laparoscopic removal of the appendix

conventional laparoscopic appendectomy

UCSF Medical Center

University of California, San Francisco

Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis

A Randomized, Controlled Trial of Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis

cellulitis/kräkning

Pre-pectoral AlloDerm® to Reinforce Tissues in Tissue Expander Breast Reconstruction

Computer-Aided, Non-Invasive, Acoustic Gastrointestinal Surveillance (AGIS) in ICU Patients

Comparison of Bovine Colostrum Versus Placebo in Treatment of Severe Alcoholic Hepatitis: A Randomized Double Blind Controlled Trial

Single-incision Laparoscopic (SILS) Versus Conventional Laparoscopic Appendectomy for the Treatment of Acute Appendicitis

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