Clinical trials: Midline Laparotomy
Esophageal Neoplasms
Esophagectomy: Sweet Versus Ivor-Lewis (ESVIL) (ECTOP-2001)
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-2001. Esophageal carcinoma is an aggressive disease with a poor prognosis.
- Trial name
- NCT01047111
- Testing
- Esophagectomy
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Fudan University
Incisional Hernia, Incisional Hernia of Midline of Abdomen
Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence
The purpose of this prospective, pivotal, multi-center, single-arm, pre-market, investigational clinical study is to assess the safety and performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line…
- Conditions
- Incisional Hernia, Incisional Hernia of Midline of Abdomen, Midline Laparotomy
- Trial name
- MARS (NCT05424484)
- Testing
- Self-Gripping Resorbable Mesh
- Where
- 13 sites in Croatia, Germany and 3 more
- Volunteers
- 123 people
- Sponsor
- Medtronic - MITG
Infection, Pneumonia
Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery
PENGUIN is a pragmatic multi-center trial investigating the effects of pre-operative mouthwash and perioperative oxygen on the incidences of pneumonia and surgical site infection (SSI) following major abdominal surgery.
- Conditions
- Infection, Pneumonia, Surgical Site Infection, Wound Infection
- Trial name
- PENGUIN (NCT04256798)
- Testing
- Chlorhexidine mouthwash, Oxygen
- Where
- 37 sites in Brazil, India and 3 more
- Volunteers
- 12,942 people
- Sponsor
- University of Birmingham
Incisional Hernia, Wound Infection
Prophylactic Sub-lay Non-absorbable Mesh Following Midline Laparotomy: PROMETHEUS (PROphylactic Mesh Trial Evaluation UltraSound)
The aim of the present study is to analyse feasibility, safety and Incisional Hernia rate using a prophylactic sub lay non-absorbable mesh [Parietex Progrip (Medtronic) ] in order to prevent Incisional Hernia following midline…
- Trial name
- PROMETHEUS (NCT04436887)
- Testing
- positioning of polypropylene strips for prophylactic purposes in closing the middle laparotomies to prevent the incisional hernia
- Volunteers
- 200 people
- Sponsor
- Francesco Pizza
Postoperative Wound Healing
Role of Subcutaneous Negative Pressure Suction Drain Placed for Ten Days on Wound Healing in Obese Patients Undergoing Midline Laparotomies
The aim of the study is to evaluate the role of subcutaneous negative pressure drain placed for 10 days on wound healing in female obese patients undergoing midline exploratory laparotomies for ovarian cancer.
- Trial name
- NCT02832076
- Testing
- Subcutaneous negative suction drain for 10 days, No subcutaneous drain
- Where
- Egypt
- Volunteers
- 90 people
- Sponsor
- Ain Shams Maternity Hospital
Incisional Hernia
Does the Use of Prophylactic Mesh Reduce Incisional Hernia?
Incisional hernia is a common condition after abdominal surgery. Because linea alba has less vascularity, incisional hernia more common in midline incisions. It is seen in the general population between 11-20%.
- Trial name
- NCT04700956
- Testing
- primary abdominal closure, abdominal closure with prophylactic mesh
- Where
- Turkey (Türkiye)
- Volunteers
- 104 people
- Sponsor
- Konya City Hospital
Incisional Hernia After Midline Laparotomy
Clinical Trial on the Use of Stratafix Symmetric vs. Resorbable Monofilament for Closure of Large Median Laparotomy in Oncological Patients
The aim of this study is to evaluate the safety and efficacy of using Stratafix (a type of symmetric, barbed, and coated suture) for abdominal wall closure in oncologic patients undergoing elective midline laparotomy, compared to…
- Trial name
- ONCOSTRAT (NCT07218679)
- Testing
- Stratafix Suture, PDS plus suture
- Where
- Spain
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Wound Complication
Comparing Wound Complications After Elective Abdominal Surgery Using Two Closure Techniques
Wound complications, increased hospital stays and post-operative morbidity are all common following abdominal surgery. Abdominal closure complications are strongly associated with the closure technique and material used.
- Trial name
- COFACTOR (NCT03527433)
- Testing
- New closure technique
- Where
- Lebanon
- Volunteers
- 274 people
- Sponsor
- American University of Beirut Medical Center
Laparotomy
Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy
Randomized controlled trial (1:1) in two parallel groups, multicentric, open-label, comparing two locoregional anesthesia (LRA) techniques as integral parts of multimodal analgesia: the control group will benefit from epidural…
- Trial name
- QORRECTCATH (NCT04985695)
- Testing
- Epidural analgesia, Bilateral rectus sheath block, Laparotomy
- Where
- 2 sites in France
- Volunteers
- 110 people
- Sponsor
- Centre Hospitalier Régional Metz-Thionville
Chronic Pain, Wound Dehiscence
Comparing Polyglactin vs Polypropylene Sutures for Rectus Sheath Closure
This randomized controlled trial aims to compare the outcomes of Polyglactin (Vicryl) versus Polypropylene (Prolene) sutures for rectus sheath closure in patients undergoing midline laparotomy.
- Conditions
- Chronic Pain, Wound Dehiscence, Surgical Site Infection (SSI), Incisional Hernia
- Trial name
- PolySuture (NCT07280975)
- Testing
- Polyglactin 910 (Vicryl) Suture, Polypropylene (Prolene) Suture
- Where
- Pakistan
- Volunteers
- 156 people
- Sponsor
- Lady Reading Hospital, Pakistan
Genital Neoplasm Malignant Female, Surgical Procedure, Unspecified
A Trial Comparing Surgeon-administered TAP Block With Placebo After Midline Laparotomy in Gynecologic Oncology
Multimodal opioid-sparing analgesia is recommended in order to prevent post-operative complications and shorten length of stay. Administration by the surgeon of local anesthetics in the abdominal wall after surgery for a…
- Trial name
- NCT04202874
- Testing
- Surgeon-administered transversus abdominis plane (TAP)
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- McMaster University
Incisional Hernia, Obesity
Randomized Controlled Prospective Multicenter Study Primary Onlay- Mesh After Elective Median Laparotomy in Patients With BMI ≥ 27
Incisional hernia is one ot the most frequently seen long term complications in abdominal surgery. Despite studies on the optimal suturing technique for laparotomies, the risk for incisional hernia after midline incision remains…
- Trial name
- NCT01507870
- Testing
- onlay mesh placement
- Where
- Austria
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Austrian Hernia Study Group
Hernia, Ventral
Small Versus Large Bite Closure of Emergency Midline Laparotomy
In daily practice, midline laparotomy is an incision frequently performed by surgeons to achieve a rapid and wide access to the abdomen.
- Trial name
- E-STITCH (NCT04098380)
- Testing
- Small Bite, Larger bite
- Where
- Egypt
- Volunteers
- 160 people
- Sponsor
- Mansoura University
Laparotomy, Hernia
Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy
Patients undergoing primary midline laparotomy for an emergency surgical intervention with a suspected septic focus in the abdominal cavity.
- Trial name
- CONTINT (NCT00544583)
- Testing
- Interrupted sutures, Continuous sutures
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Heidelberg University
Incisional Hernia, Emergency Laparotomy
Preemer Trial - Prophylactic Mesh Versus no Mesh in the Midline Emergency Laparotomy Closure for Prevention of Incisional Hernia: a Multi Center, Double-blind, Randomized Controlled Trial
244 patients, who have an emergency midline laparotomy for any gastrointestinal reason, will be randomized in a 1:1 ratio either to mesh group with a retrorectus prophylactic self-gripping mesh or to control group with 4:1 small…
- Conditions
- Incisional Hernia, Emergency Laparotomy, Midline Laparotomy, Hernia Prevention
- Trial name
- NCT04311788
- Testing
- Prophylactic self gripping mesh, Slowly absorbable continuous monofilament suture
- Where
- 7 sites in Finland
- Volunteers
- 109 people
- Sponsor
- University of Oulu
Incisional Hernia After Midline Laparotomy, Emergency Abdominal Surgery
Prophylactic Mesh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT)
The PREEMPT trial is a multicenter randomized controlled trial comparing prophylactic onlay biosynthetic mesh reinforcement with primary suture closure in adult patients undergoing emergency midline laparotomy.
- Trial name
- PREEMPT (NCT07753551)
- Testing
- Prophylactic Biosynthetic Mesh Placement, Direct suture
- Where
- Italy
- Volunteers
- 189 people
- Sponsor
- University of Rome Tor Vergata
Postoperative Pain, Postoperative Nausea and Vomiting
Surgical Site Infiltration of Exparel vs TAP Block With Exparel in Patients Undergoing Laparotomy Via Midline Incision
This is a randomized-controlled prospective study to be conducted at Danbury Hospital and Norwalk Hospital to compare postoperative opioid consumption and pain scores of patients with suspected or known gynecologic malignancies…
- Conditions
- Postoperative Pain, Postoperative Nausea and Vomiting, Opioid Use
- Trial name
- NCT03870685
- Testing
- TAP Block, Surgical Site Infiltration, Exparel
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Danbury Hospital
Wound Dehiscence
Burst Abdomen in Emergency Midline Laparotomy: Incidence and Risk
The study was conducted in 250 patients who underwent midline Laparotomy at Kasr Al-Ainy emergency department, Cairo University from August 2017 until March 2018.
- Trial name
- NCT03684902
- Testing
- emergency midline exploratory laparotomy
- Where
- Egypt
- Volunteers
- 250 people
- Sponsor
- Cairo University
Incisional Hernia
Usefulness of a Prothetic Absorbable Mesh in Incisional Hernia Prevention After Midline Laparotomy
Background: Development of an incisional hernia is one of the most frequent complications of midline laparotomies requiring reoperation.
- Trial name
- PREBIOUS (NCT02208557)
- Testing
- Reinforcement with Absorbable Mesh, Control CT, Clinical Follow Up
- Where
- 6 sites in Spain
- Volunteers
- 488 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Abdominal Aortic Aneurysm, Morbid Obesity
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
The aim of the study is to describe the effectiveness of Optilene® Silver Mesh Elastic on prevention of surgical site infection (SSI) at 6 months follow-up in patients undergoing urgent laparotomy by collecting clinical data on…
- Trial name
- SSIHLVER (NCT06547138)
- Testing
- Prophylactic mesh
- Where
- 5 sites in Spain
- Volunteers
- 110 people
- Sponsor
- Aesculap AG