In short
There are currently 2 ongoing clinical trials focused on improving outcomes for patients who have undergone laparotomy, a major abdominal surgery. These trials are investigating different approaches to post-surgical care, including nutritional support and prevention of digestive complications.
Clinical trial locations
- Denmark
- Germany
Study on Early vs. Delayed Supplementary Parenteral Nutrition with SmofKabiven for Patients After Major Emergency Abdominal Surgery
This trial is designed for patients who have undergone major emergency abdominal surgery through a midline laparotomy, which is an urgent surgical procedure performed when life-threatening conditions occur in the abdominal area.
Inclusion criteria: The trial accepts patients who are at least 18 years old and have had a primary emergency midline laparotomy. Participants must have a nutritional risk score (NRS-2002) below 7 before surgery, no medical reasons preventing normal eating or tube feeding after surgery, and must be consuming less than 30% of their recommended calories on the second day after surgery.
Exclusion criteria: Patients who have not undergone major emergency abdominal surgery, those outside the specified age range, participants from clinical trial groups not included in this study, and vulnerable populations requiring special protection are not eligible.
Study focus: The trial investigates whether the timing of providing additional nutrition through the veins makes a difference in preventing hospital-acquired infections after surgery. Researchers are comparing two approaches: starting supplementary parenteral nutrition early versus delaying it. The study monitors infection rates, complications, length of hospital stay, and mortality rates at 30, 90, and 180 days after surgery. It also tracks the amount and type of energy and protein patients receive during their hospital stay.
Investigational treatment: The study uses SmofKabiven and SmofKabiven Perifer, which are emulsions delivered through a vein containing a mix of essential nutrients including amino acids, oils, and minerals. This type of nutrition is important for patients who cannot eat or absorb enough nutrients through their digestive system during recovery.
Study on Oral Lidocaine for Reducing Gastrointestinal Issues in Patients After Abdominal Surgery
This trial focuses on female patients who have undergone gynecologic surgery through a longitudinal laparotomy, which is a surgical cut made along the length of the abdomen.
Inclusion criteria: Participants must be female, aged between 18 and 75 years, and have undergone gynecologic surgery entirely through a longitudinal laparotomy. They must have an ECOG Performance status of up to 1, meaning they are either fully active or have some symptoms but can still do light work. Patients must be able to understand and consent to the study, be likely to follow study rules, and agree to have a peridural catheter for pain management.
Exclusion criteria: Male patients are not eligible. Patients outside the specified age range and those belonging to vulnerable populations requiring special protection cannot participate.
Study focus: The trial investigates whether oral lidocaine can prevent gastrointestinal problems that commonly occur after abdominal surgery. These problems include digestive discomfort and postoperative ileus, a condition where the intestines temporarily stop moving properly after surgery, causing bloating, pain, nausea, and delayed bowel function. The study is double-blind, meaning neither participants nor researchers know who receives the actual medication or a placebo. Participants are monitored using the I-FEED score, which measures the severity of gastrointestinal symptoms at various points after surgery.
Investigational treatment: The study tests ORE-001, which is oral lidocaine in film-coated tablet form. Lidocaine is a local anesthetic that works by blocking sodium channels, reducing nerve signal transmission to alleviate pain and discomfort. This phase 2 trial aims to determine if this medication can effectively reduce digestive complications following surgery.
Summary
The two ongoing clinical trials for laparotomy patients are being conducted in Denmark and Germany, each addressing different aspects of post-surgical care. The Danish trial focuses on optimizing nutritional support timing to reduce infection risk after emergency surgery, while the German trial investigates preventing digestive complications in female gynecologic surgery patients. Both studies reflect the medical community's efforts to improve recovery outcomes and reduce common complications following major abdominal surgery. Each trial uses distinct approaches—one through intravenous nutrition and the other through oral medication—demonstrating the variety of strategies being explored to enhance patient care after laparotomy procedures.
