Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Seroma

Breast Diseases

Skin Diseases

Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.

Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.

Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

A negative pressure drain will be inserted below the lower flap directing to the axilla.

Insertion of a single drain

Two drains will be inserted into the axilla and below the lower flap in the double drains group.

Insertion of double drains

One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

Ultrasonography after removal of the drains

It is not known whether decreasing the number of drains used decreases patients' discomfort and duration of hospital stay without increasing seroma formation after mastectomies.

Hypothesis. Use of one drain increases patient comfort without increasing seroma formation after modified radical mastectomy (MRM) as compared to double drains.

Material and Method: Sixty patients undergoing MRM at Diskapi Yildirim Beyazit Training and Research Hospital will be randomised into single versus double drains groups. A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group or two similar drains will be inserted into the axilla and below the lower flap in the double drains group. Drains will be removed if the output is less than 30 ml. Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Age, body mass index smoking history, coexisting diseases of the patients duration of the hospital stay, duration of the drains in place, total drain output in the first three days after the operation and the need and frequency of aspirations due to seroma formation will be recorded. Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains, The duration of the longer staying drain in the double drain group will be recorded for the duration of the drain in place parameter.

Background: Seroma is one of the most common complications after mastectomies. Seroma formation results in delays in wound healing, incisional dehiscence, infections and long hospital stay. Although there are studies proving that drains do not prevent seroma formation, the use of drains for that purpose is still very common. Decreasing the number of drains used after mastectomies has been shown to decrease patients' discomfort and duration of hospital stay without increasing seroma formation.

Objective: To investigate the effects of single versus double drains on patient comfort and seroma formation after modified radical mastectomy (MRM) Material and Method: Sixty patients undergoing MRM at Diskapi Yildirim Beyazit Training and Research Hospital will be randomised into single versus double drains groups. A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group or two similar drains will be inserted into the axilla and below the lower flap in the double drains group. Drains will be removed if the output is less than 30 ml. Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography. Age, body mass index smoking history, coexisting diseases of the patients duration of the hospital stay, duration of the drains in place, total drain output in the first three days after the operation and the need and frequency of aspirations due to seroma formation will be recorded. Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains, The duration of the longer staying drain in the double drain group will be recorded for the duration of the drain in place parameter. Two groups will be compared with chi-square, student's t-test or Mann-Whitney U test. P\<0.005 will be considered as significant.

Single Versus Double Drains After Mastectomy

Comparison of Single Versus Double Drains After Modified Radical Mastectomy

Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).

Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography..

Ankara Diskapi Training and Research Hospital

Melih Akinci

Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.

Single Drain

Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.

Double Drain

Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.

Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.

Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.

Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.

Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.

Total

Age, Continuous

Sex: Female, Male

Melih Akinci, MD, Associate Prof

Patient Comfort Scale

Seroma Formation

Length of Hospital Stay

Overall Study

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatitis

Pancreatic Neoplasms

Pancreatic Diseases

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Patients who will not receive intraperitoneal drainage following pancreas resection.

Patients who will receive drains, the standard of care treatment, following pancreas resection.

A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.

No Drains

A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).

Drains

William E Fisher, MD

This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery.

The rate of pancreatic fistula after pancreas resection is about 10% and surgeons have traditionally placed drains near the pancreatic anastomosis to control this potentially very serious complication. In recent years, advances in interventional radiology have allowed safe percutaneous drainage of intra-abdominal fluid collections. Some surgeons have abandoned the routine use of prophylactic drains placed at the time of pancreas resection and rely on percutaneous drainage for the minority of patients who develop a pancreatic fistula.

Hypothesis:

This randomized prospective trial is designed to test the hypothesis that pancreatectomy without routine intraperitoneal drainage does not increase the severity or frequency of complications within 60 days of surgery. The primary endpoint to assess the severity of complications will be the number of patients with any ≥ Grade II complication. Severity of complications experienced will also be assessed by comparing the number of patients with, any ≥ Grade III complication, any serious adverse event (SAE), and the median complication severity grade of all complications. The frequency of complications will be assessed by comparing the number of patients with 1, 2, 3, 4, 5, or more than 5 complications of any severity grade.

Objectives:

Primary: Difference in 60-day ≥ Grade II complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

Secondary:

A. 60-day ≥ Grade III complication rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

B. Serious adverse event (SAE) rate comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

C. Median complication severity grade comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

D. 60-day frequency of complications (any Grade) between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

E. 60-day, and 90-day mortality rate comparison between patients who receive a pancreatetomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

F. Rate of specific complications compared between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

G. Length of stay (index admission and total within 60 days) comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

H. Crude cost comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

I. Quality of life comparison between patients who receive a pancreatectomy without routine intraperitoneal drainage and those who do receive routine intraperitoneal drainage.

Pancreas Resection With and Without Drains

A Randomized Prospective Multicenter Trial of Pancreas Resection With and Without Routine Intraperitoneal Drainage

The primary outcome measure was defined as the number of patients with grade 2 or higher grade complications within 60 days of the date of surgery will be meticulously recorded using specific and standardized definitions. Complications will be graded in severity using the Common Terminology Criteria for Adverse Events CTCAE (v4.0) (Grade 1-5) unless otherwise stated below. For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.

This secondary outcome measure was defined as the number of patients with one or more complications with grade 3 or higher grade within 60 days of the date of surgery. Complications will be graded in severity suing the Common Terminology Criteria for Adverse Events, CTCAE(v4.0) (Grade 1-5). For grading schemes with A, B, C rather than 1-5, severity scores will be converted to 1-3.

This secondary outcome measure is the number of patients with one or more SAE within 60 days of the date of surgery. This outcome will be presented in the Adverse Event Module. The total number of patients affected were 344 (# of no drain=170 vs # of drain=174) and two patients were experienced the serious adverse event (SAE) defined by the protocol. Refer to the Adverse events tables for specifics.

This will be calculated for all patients and among just the patients who experienced complications. The complication will be graded in severity using the Common Terminology Criteria for Adverse Events, CTCAE (v4.0) and the severity grade is from 1 to 5. The outcome measure is the median of the Sum of the complication grades of each complication experienced by the patient/# of complications experienced

This is the median number of complications per patients.

The outcome measure is the number of patients with each particular complication but not including serious adverse events. The complication is using using the Common Terminology Criteria for Adverse Events CTCAE (v4.0).

This is the median of length of stay for the index admission. An index admission is an admission in a hospital with a principal diagnosis of a specified condition that meets the inclusion and exclusion criteria for that measure. Total days in the hospital within 60 days of surgery was not collected for analysis. Only length of stay for the index admission was reported.

This is the crude cost of subsequent procedures (CT scan, paracentesis, percutaneous drainage, reoperation) and the length of the index admission and any subsequent readmission. Data were not collected for analysis.

Subjects will complete the FACT-PA quality of life instrument and the results will be recorded. The quality of life scores at 30 days was collected for analysis.

The Functional Assessment of Cancer Therapy-Pancreatic Cancer (FACT-PA), is a self-administered pancreas-specific health status survey. The instrument is scored on a scale of 0-28 for Physical well-being subscale(PWB), Social/Family well-being subscale(SWB), Functional well-being subscale(FWB), and on a scale of 0-24 for Emotional well-being subscale(EWB), and on a scale of 0-36 for additional condition of FACT-PA (FACT-PA subscale). The total FACT-G score is the sum of PWB, SWB, FWB, and EWB and the range of 0\~108. The total FACT-PA score is the sum of the total FACT-G score and FACT-Pa subscale and the range of 0\~144. A lower score represents the worst quality of life.

Baylor College of Medicine

Director, Elkins Pancreas Center, Professor, Michael E. DeBakey Department of Surgery

Patients did not receive intraperitoneal drainage following pancreas resection.

No Drains: A closed-suction drain was not be placed near the transection margin at the time of surgery in the experimental group.

Patients did receive drain(s), the standard of care treatment, following pancreas resection.

Drains: A drain was placed near the pancreatic transection margin at the time of surgery (standard of care).

Race (NIH/OMB)

A potential weakness of the current study is that it took 5 years to reach targeted accrual.

Amy McElhany, Clinical Research Manager

the study is powered to be able to detect a 15% difference in the ≥ Grade II complication rate between the drain and no drain groups. A total of 342 evaluable patients will be needed for the two study groups (n=171 per group) in order to achieve 80% power to detect a 15% increase or decrease in the complication rate with a significance level of 0.05.

60-day ≥ Grade II Complication Rate

60-day ≥ Grade III Complication Rate

Serious Adverse Event (SAE) Rate

All patients

For just the patients with complications

Median Complication Severity Grade

60-day Frequency of Complications

90-day Mortality Rate

Pancreatic_leak_fistula

Postoperative_Abdominal_FluidCollection

Biliary_leak

Enteric_leak

Lymph_Leak

Diarrhea

Gastroparesis_DelayedGastricEmptying

SmallBowelObstruction

Intra_abd_abscess

Wound_Dehiscence

Wound_Infection

Fever

Patients who will not receive intraperitoneal drainage following pancreas resection.

No Drains: A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.

Patients who will receive drains, the standard of care treatment, following pancreas resection.

Drains: A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Single Versus Double Drains After Mastectomy	NCT02202252	Breast Cancer Mastectomy	Insertion of a ... Insertion of do... Ultrasonography...	18 Years - 80 Years	Ankara Diskapi Training and Research Hospital
Pancreas Resection With and Without Drains	NCT01441492	Pancreas Tumor Pancreatitis	No Drains Drains	18 Years -	Baylor College of Medicine
Pancreas Resection With and Without Drains	NCT01441492	Pancreas Tumor Pancreatitis	No Drains Drains	18 Years -	Baylor College of Medicine

Spots Global Cancer Trial Database for drains

Every month we try and update this database with for drains cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for drains

Every month we try and update this database with for drains cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for drains cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.