Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Hematinics

All Drugs and Chemicals

Liver Extracts

Methylene Blue

Participants enrolled in this arm have an abdominal drain positioned at the end of the operation (any type, inserted from right flank with the tip close to the esophago-jejunal or Gastro-jejunal anastomosis and the duodenal stump). Drain will stay in place until postoperative day (POD) 4th (drain output and quality will be registered). If normal drain debt and patient have no abdominal complications that need reoperation and/or percutaneous drain placement until POD 4, a methylene-blue test is be performed (200 ml water + 5 ml blue orally, check drain after 60 minutes: negative test if no blu was seen in the drain). If negative-blue test drain can be removed according to centre preference (no strict POD defined); if positive-blue test complication will be treated according to centre preference. Only in this arm drain related complications are registered. Need for reoperation and/or percutaneous drain placement (primary outcome) are registered.

Participants enrolled in this arm do not have any abdominal drain placed at the end of the operation. Postoperative management (e.g. resume of oral intake, anastomosis integrity tests) is left to centre preference. Need for reoperation and/or percutaneous drain placement (primary outcome) are registered.

In No Drain arm (experimental) no abdominal drain is placed at the end of the operation.

Avoid drain placement

In Drain arm (sham comparator) an abdominal drain is inserted in the abdomen from the right flank, passing below the liver (close to the duodenal stump) with the apex behind the esophago-jejunal (in total gastrectomy) or gastro-jejunal (in subtotal gastrectomy) anastomosis.

Drain placement

Giovanni de Manzoni, Prof

Prophylactic use of anastomotic drain in upper gastrointestinal surgery has been questioned in the last 15 years but only small studies have been conducted. In 2015 a Cochrane meta analysis on four Randomized Controlled Trials (RCT) concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless the Authors evidenced the moderate/low methodological quality of the included studies and highlighted how 3 out of four came from Eastern countries. Despite the above mentioned limits, Enhanced Recovery After Surgery (ERAS) society published the guidelines for gastrectomy that strongly recommend, with high evidence level, to avoid routine use of drain in gastric surgery. After 2015 some other retrospective studies have been published, all with inconsistent results. Our objective is to perform a multicentre prospective trial in a large western cohort of patients to establish wether avoid routine use of anastomotic drain does not led to an increasing of postoperative invasive procedure.

The leading surgeon and the patient will be blinded to the arm assigned until the end of the operation. No blinding is provided for the patient, care providers, or coordinating researcher after the operation. After the operation we thought that was unreliable to go ahead with participants blindness considering that one arm has an evident drain and the other arm has no drain. Considering that clinicians will need to check drain quality and remove the tube in treatment group we considered not possible to mask the care providers or investigators on this practice.

Gastrectomy With or Without Drainage (ADiGe)?

A Randomised Multicentre Controlled Trial of Gastrectomy With or Without Prophylactic Abdominal Drainage. The Abdominal Drain in Gastrectomy Trial (ADiGe Trial)

Data obtained through this study may be provided to qualified researchers with academic interest in abdominal surgery. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.

Incidence of reoperation AND/OR percutaneous placement of an additional drain within postoperative day 30 (composite outcome)

Complications are classified according to International consensus on a complications list after gastrectomy for cancer - Baiocchi et Al, Gastric Cancer, 2019 and stratified according to Clavien-Dindo classification.

Only in Drain Group complications related to drain placement (e.g. bleeding from drain site) will be recorded

Azienda Ospedaliera Universitaria Integrata Verona

Skin and Connective Tissue Diseases

Breast Neoplasms

Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain

Drain

Seroma is a common complication following modified radical mastectomy(MRM). Closed drainage is used routinely to reduce incidence of seroma. Usually two drains are used in patients who underwent MRM to reduce post operative seroma. It is often associated with significant patient discomfort and prolonged fluid drainage.

The aim of this study is to evaluate effect of number of drains on seroma formation rate, postoperative pain and hospital stay during the immediate postoperative period after mastectomy for breast cancer.

Modified Radical mastectomy is commonly performed procedure for carcinoma breast. After surgery two drains are placed, one in axilla and one beneath the flap. The use of two drains is associated with significant post operative discomfort and pain. On the other hand two drains have not been proven to decrease post operative seroma formation.

Single vs. Double Drain in Modified Radical Mastectomy

Single vs. Double Drain in Modified Radical Mastectomy: A Randomized Control Trial

fluid collection beneath the flap sufficient to cause patient discomfort and pain

as described by center of disease control (CDC) criteria

measured on visual analogue scale (1 to 10) in first 24 hours after surgery.

flap discoloration due to compromised blood supply of flap

Memon Medical Institute

Consultant General Surgeon

Symptoms and General Pathology

Seroma

Coagulants

Antineoplastic Agents

Central Nervous System Depressants

Amino Acids

Hemostatics

Urethane

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Lysine

This is standard of care to use Tissue Glu in addition to a drain. Pre-operatively, as well as on post-operative patients will be asked to complete a questionnaire that addresses their pain, impact of drains on activities of daily living, social and physical activities. Patients will also be asked to provide information regarding who is caring for the drains, the impact of drains on the caregiver, the amount of anxiety the patient has related to drain removal and the amount of pain associated with drain removal

This group utilizes Tissue Glu without the presence of a drain. Pre-operatively, as well as on post-operative patients will be asked to complete a questionnaire that addresses their pain, impact of drains on activities of daily living, social and physical activities. Patients will also be asked to provide information regarding who is caring for the drains, the impact of drains on the caregiver, the amount of anxiety the patient has related to drain removal and the amount of pain associated with drain removal

This is standard of care to use traditional closed-suction drains. Pre-operatively, as well as on post-operative patients will be asked to complete a questionnaire that addresses their pain, impact of drains on activities of daily living, social and physical activities. Patients will also be asked to provide information regarding who is caring for the drains, the impact of drains on the caregiver, the amount of anxiety the patient has related to drain removal and the amount of pain associated with drain removal

Once adequate hemostasis has been achieved during surgery and the abdominal fascia and flaps have been irrigated, Tissue Glu will be applied. Tissue Glu is applied at approximately one centimeter intervals while remaining one centimeter away from the umbilicus and inferior incisions.

Tissue Glu

Drains will be placed during surgery to allow for the drainage of seroma which may develop after surgery

Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers

Questionnaires

Andrea Moreira, MD

Drains are routinely utilized in breast reconstruction when using abdominal tissue of the patient to remove fluid buildup while the body heals after surgery. However, drains are associated with patient discomfort, anxiety, decreased mobility, increased hospital stays and outpatient visits. Drains can also serve as a site of origin for infection as the system is not completely closed, and infectious organisms could theoretically use the drain as point of entry.

This proposed study investigates a potential novel mechanism to prevent the development of seromas (pockets of clear fluid which can develop after surgery) in patients who undergo breast reconstruction with their own abdominal tissue. By eliminating the required use of a drain, the study team expects patients to have less pain and use less pain medication, as well as more satisfaction with their overall surgical experience.

Objectives:

1. Establish the safety of a lysine-derived urethane adhesive (TissuGlu, Cohera Medical) in patients undergoing autologous abdominal-based breast reconstruction. This will be assessed via analyzing complication profiles of patients post-operatively. The primary endpoints are rate of seroma development, need for seroma drainage and time to drain removal (if in drain group).
2. Determine if there is a difference in pain and other quality of life measures when comparing patients who do and do not have abdominal drains. This will be assessed via pain medicine utilization and by delivering a targeted survey pre-operatively, as well as at post-operative day three and four weeks.

Study Design:

Patients will be randomized to one of three arms: 1) Traditional closed-suction drains, 2) TissuGlu with closed-suction drains and 3) TissuGlu without closed-suction drains.

This study has three parallel groups. One experimental and two control groups

The study is "semi-blind" in that patients will not be told which treatment they are receiving. If the patient is assigned to one of the drains groups, she will know post-operatively that she has drains, but she will not know if TissueGlu was utilized. The doctor will be aware of what treatment the patient is receiving, as he or she will administer the drug

Drain-Less Abdominally Based Breast Reconstruction Using Lysine-Derived Urethane Adhesive

Drain-Less Abdominally Based Breast Reconstruction Using a Novel Lysine-Derived Urethane Adhesive (TissueGlu, Cohera Medical)

Number of seromas which develop during the first 30 days after surgery.

Patients will be given a questionnaire pre-operatively and the same questionnaire post-operatively. The change in these questionnaires will be compared between groups

Use of pain medicine after surgery between groups, as indicated by chart review

Time from surgery to the removal of the drain for any reason, in patients who were given a drain

Case Comprehensive Cancer Center

Nervous System Diseases

Pain, Postoperative

Pain

Postoperative Complications

Neurologic Manifestations

Patients in experimental arm will receive surgery (either laparoscopic or robotised laparoscopic surgery). The exsufflation will be carrying out by a drain.

Then, patients will be followed-up during 7 days after surgery.

Laparoscopic or robotised laparoscopic surgery + Trocar

Patient in this experimental arm will receive surgery (either laparoscopic or robotised laparoscopic surgery). The exsufflation will be carrying out carried out manually using the trocar (standard of care).Then, patient will be followed-up during 7 days after surgery.

A 10 mm suction drain is placed through a trocar in the right hypochondrium (liver).

Manual exsufflation

Fabrice NARDUCCI, PhD

This is a phase III, monocenter and randomized study, which evaluates the effectiveness of peritoneal gas drainage on postoperative pain in laparoscopic or robotic laparoscopic gynaecological surgery. This study aim is to assess the efficacy of active gas extraction with a drain (arm A) in comparison to manual evacuation (arm B,) in terms of pain incidence reduction linked to laparoscopic or robotic laparoscopic surgery.

The primary objective is to assess the efficacy of active gas aspiration compared to simple manual gas evacuation to reduce the incidence of specific laparoscopic surgery pain.

Secondary objectives of this study include :

* Comparing the evolution of specific pains after laparoscopic surgery, between study groups
* Description of postoperative antalgics consumption in each group
* Evaluating the safety of the evaluated procedure
* Evaluating the impact of the evaluated procedure on hospitalisation duration ( for patients with ambulatory surgery initially planned)

Patient will be pre-selected before medical operation. During the surgery, if the surgeon performs only the laparoscopy, the patient will be randomized. Then, the allocated procedure (with or without drain) will be carried out.

Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery

Drain-Exsu: Phase III Trial Assessing the Effect of Peritoneal Gas Drain on Postoperative Pain in Gynecologic Minimally Invasive Surgery

Comparison on portion of patients with significative early pain linked to the laparoscopic surgery, between the two groups (Chi-2 tests).

The maximum score pain will be evaluated by the mean difference between each group (Student or Mann-Whitney tests).

The site of pain will be reported to describe pain overall, but also specifically in the shoulders and/or subcostal areas and pain at trocar holes.

Pain will be measured with the numerical pain assessment scale (score from 0 to 10).

A notebook filled in by the patient at home with a daily assessment of pain according to the numerical pain assessment scale, with a phone call from the nurse on day 7 (considering that the day of the surgery is day 0).

Qualitative description through patient notebook.

Quantitative description through patient notebook.

Safety procedure will be describe through adverse events notification potentially related to the procedure and their grade (total amount of AE, maximal grade of AE per patient).

Impact of the peritoneal gas aspiration technique on the hospitalisation duration for patient with ambulatory surgery.

Centre Oscar Lambret

Wounds and Injuries

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Wound drain is kept until until a scheduled visit three weeks after the surgery unless the drain produced less than 30 ml/day for two consecutive days, in which case it could be removed earlier.

When the drain produces less than 100 mL over 24 hours, the self-suction bulb is removed and the drain is shortened and drained into a colostomy bag placed around the site of drain insertion. A request is filed with the community nursing system to have a visiting nurse to pull out the drain 1-2 cm per day.

Suction drain either kept for three weeks or gradually pulled out.

Suction drain

This prospective randomized non-inferiority study is designed to compare the rate and severity of complications after axillary and inguinal lymph node dissection in stage III melanoma patients in a study group where the drain is left in place for three weeks and a control group consisting of patients managed according to the standard institutional protocol. Furthermore, variables associated with complications will be examined.

Consecutive stage III melanoma patients 18 years or older referred to our institution for axillary or inguinal lymph node dissection is eligible for inclusion of the study. A bipolar vessel sealing device (LigaSure, Covidien) will be used for dissection in all procedures. All patients will be scheduled for an outpatient visit with an experienced nurse three weeks after the surgery. Any deviation from the normal postoperative course will be recorded in the electronic patient journal. Complications are graded according to the Clavien-Dindo classification. Patients with complications or with suspected complications at the three-week follow up will be scheduled for new an outpatient visit. Patient demographics, clinicopathological characteristics of the primary melanoma, indication for the procedure, length of postoperative stay and early complications and treatment for complications will be collected for analysis

Early Complications After Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients

Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients: A Prospective Randomized Trial of Two Approaches to Wound Drainage

To determine if the study group was non-inferior to the control group

Frequency of each complication and an analysis of possible risk factors.

Oslo University Hospital

Consultant in general and plastic surgery

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Fistula

Pancreatic Fistula

Pancreatic Cancer

Surgical drains are placed as a standard of care (control arm) or not (experimental arm)

No drain

Bergthor Björnsson

Bobby Tingstedt

The study compares regular use of surgical drains and no use of surgical drains in patients subjected to pancreaticoduodenectomy with expected low to intermediate risk for post operative pancreatic fistula.

Post-operative Drainage After Pancreaticoduodenectomy

Post-operative Drainage After Pancreaticoduodenectomy: A Randomized Controlled Trial of Patients With Intermediate and Low Risk for Pancreatic Fistula

Lund University

Linkoeping University

Associate Professor

Behaviors and Mental Disorders

Hyperthermia

Fever

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

DIEP/ MS-TRAM breast reconstruction free flap raise performed with conventional diathermy

DIEP/ MS-TRAM breast reconstruction free flap raise performed with PEAK PlasmaBlade™

Abdominal free flap raise performed with conventional diathermy. Settings: cutting 40 Watt, coagulation 40 Watt.

Conventional diathermy

Abdominal free flap raise performed with PEAK PlasmaBlade™ Settings: cutting 7 (35 Watt), coagulation 7 (35 Watt)

PEAK PlasmaBlade™

Thessa R Friebel, MSc

Matthew Griffiths, MBBS, MD

Selim Cellek, MD, PhD

Electrosurgery allows for dissection with simultaneous haemostasis. One of its disadvantages is that the heat production can cause injury to the surrounding tissue which may result in wound healing problems and an increased rate of seromas.

The PEAK PlasmaBlade™ (PPB) is a new electrosurgery device which may overcome this by having the ability to operate on a lower temperature, therefore reducing collateral thermal damage.

Different experimental studies in both animal and human models comparing the PEAK PlasmaBlade™ and other surgical dissection devices for incisions have shown a reduction in width of zone of thermal injury, reduction in wound inflammation, increased wound strength and reduced scaring in favour of the PEAK PlasmaBlade™ and comparable to scalpel incisions. A prospective clinical study published by Dogan et al. in 2013, including 46 consecutive breast cancer patients receiving a modified radical mastectomy either with the conventional diathermy (n=22) or the PEAK PlasmaBlade™ (n=24), showed a statistically significant reduction in wound fluid production (p=0.025), leading to earlier drain removal (p=0.020) in the PEAK PlasmaBlade™ group.

Comparable to oncological breast surgery, prolonged drain requirements for high wound fluid production and seromas are often experienced in the abdominal donor side after deep inferior epigastric perforator/ muscle sparing transverse rectus abdominis muscle flap (DIEP/MS-TRAM) breast reconstruction. To evaluate the effects of the PEAK PlasmaBlade™ for abdominal dissection in autologous breast reconstruction on wound fluid production and complications such a seroma, this double blinded randomised controlled clinical trial was conducted.

It was hypothesised the use of the PEAK PlasmaBlade™ for the harvest of the DIEP/ MS-TRAM flap would result in 1) a shorter abdominal drains requirement (days); 2) a lower total drainage volume (mL) from the abdominal drains; 3) lower levels of inflammatory cytokines in the drain fluid and 4) less and smaller seromas would be identified using ultrasound in the follow-up period.

The study was conducted between November 2016 and May 2018 in a single centre, St. Andrew's Centre for Plastic Surgery and Burns in Broomfield Hospital, in Chelmsford United Kingdom, including all immediate and delayed DIEP/MS-TRAM patients of two senior plastic surgeons, who agreed to participate and met the in-/exclusion criteria. All participants signed an informed consent. Randomisation was performed using the Trans European Network for Clinical Trials Service (TENALEA), which is an internet-based randomisation system. Patients were either allocated to the 'Group A - diathermy' or 'Group B - PEAK PlasmaBlade™. Blinding was broken after the last patient had completed the 6-week follow-up period.

All patients underwent a standardised DIEP or MS-TRAM breast reconstruction procedure. A scalpel was used to make the skin incision to the depth of the dermis. The raising of the flap was subsequently done either using the PEAK Plasma Blade™ or conventional diathermy. Before the abdominal closure two 15 French Blake drains were inserted and secured to the skin with a 2.0 Silk suture and connected to a low vacuum wound drainage system (85 kPa/neg 100mmHg). Every patient would wear an abdominal binder (9-inch, Marena) for 6 weeks post-operatively. Data on drain requirement, total daily abdominal drainage, pain, mobility and complications were collected during the inpatient stay. On day 0,1 and 2 also abdominal drain fluid was obtained. This was stored in labelled 1.5mL Eppendorf tubes in a -80°C freezer. The samples were sent to Myriad RBM, Inc. a clinical laboratory improvement amendments (CLIA) certified biomarker testing laboratory located in Austin, Texas (United States) for inflammatory cytokine analysis. Abdominal drains were removed when draining 30mL or less in 24 hours. Following discharge, patients were seen in the outpatient department after two and six weeks. At both follow-up appointments, data on complications were recorded. Also an abdominal ultrasound was performed using the V-Universal™ Stand portable ultrasound machine (SonoSite, Inc) to identify and measure abdominal seroma collections. Seromas were only aspirated if they were causing discomfort to the patient. After completion of the 6-week follow-up period patients were discharged from the study. All data were collected by the blinded principle study investigator and logged onto an electronic database.

Data from an in the investigator's unit conducted pilot study on drain requirement was used to perform a power calculation.This results in a minimal sample size of 53 patients for each group (106 overall).

Normal distribution was evaluated using the Shapiro-Wilk test, following this continuous data was analysed using the independent sample t-test or Mann-Whitney U Test to identify a statistically significant difference between the two groups. All right skewed was log transformed, if this resulted in a normal distribution the independent samples t-test was used to determine statistical significance. For categorical data the Pearson Chi-Square Test for numbers over 5 was used. If the count was equal to or less than 5 the Fisher's Exact Test was used to determine statistical significance. A value below or equal to 0.05 (2-tailed) was considered to be statistically significant. Linear regression (Cox proportional hazard model) was used to identify significant determinants for the time to drain removal. Variables that had a significant p-value in the univariate analysis were included in a multivariable analysis. Significant determinants could indicate confounding factors for which would be corrected. Logistic regression was used to identify determinants for complications and the presence of seroma at the 2- and 6-week abdominal ultrasound scan. Variables that had a significant p-value in the univariate analysis were included in multivariable analysis, if none of the determinates were significant p values \<0.10 were included in the multivariable analysis. Significant determinants could indicate confounding factors for which would be corrected.

Patients randomised between having their procedure performed with one of two different electrosurgery devices

Patients and investigator collecting data were both blinded for which machine was used

Females undergoing immediate or delayed abdominal based free flap breast reconstruction

Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction

Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction - a Single Centre, Double Blinded Randomised Controlled Trial

Time required to raise abdominal flap (minutes)

Inflammatory markers in abdominal drain fluid: TNF-alpha, IL-4, IL-6,IL-8, IL-10, IL-18, MIP-1 alpha, MIP-1 beta, MCP-1

Numerical rating scale (NRS) 0 to 10 (with 0 being no pain and 10 the worse pain imaginable)

Total amount of fluid drained from abdominal wound (millilitres) during admission

Number of complications during the study experienced by each patient (for example: Flap problems, haematoma, delayed abdominal wound healing, seroma)

Number of interventions required to deal with complication for each patient (for example needle aspiration, surgery, iv antibiotics)

Size (length, width and depth was measured and used to estimate the size using the formula of half an ellipse)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gastrectomy With or Without Drainage (ADiGe)?	NCT04227951	Gastric Cancer	Avoid drain pla... Drain placement	18 Years -	Azienda Ospedaliera Universitaria Integrata Verona
Single vs. Double Drain in Modified Radical Mastectomy	NCT02411617	Breast Cancer	Drain	-	Memon Medical Institute
Drain-Less Abdominally Based Breast Reconstruction Using Lysine-Derived Urethane Adhesive	NCT03159598	Breast Cancer	Tissue Glu Drain Questionnaires	22 Years - 65 Years	Case Comprehensive Cancer Center
Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery	NCT04974125	Gynaecologic Ca...	Drain Manual exsuffla...	18 Years -	Centre Oscar Lambret
Early Complications After Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients	NCT04680182	Melanoma Complication	Suction drain	18 Years -	Oslo University Hospital
Post-operative Drainage After Pancreaticoduodenectomy	NCT05270564	Pancreatic Canc...	Drain No drain	18 Years -	Linkoeping University
Impact of Peritoneal Gas Drain on Postoperative Pain for Gynaecological Cancer Patients With Minimally Invasive Surgery	NCT04974125	Gynaecologic Ca...	Drain Manual exsuffla...	18 Years -	Centre Oscar Lambret
Comparison of PEAK PlasmaBlade™ to Conventional Diathermy in Abdominal Based Free Flap Breast Reconstruction	NCT04350411	Breast Reconstr... Breast Cancer	Conventional di... PEAK PlasmaBlad...	18 Years - 80 Years	Anglia Ruskin University

Spots Global Cancer Trial Database for drain

Every month we try and update this database with for drain 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 drain

Every month we try and update this database with for drain 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 drain 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.