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Postoperative Ileus clinical trials

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NCT ID: NCT02056405 Recruiting - Postoperative Ileus Clinical Trials

Effect of Mosapride on Postoperative Ileus in Patients Undergoing Colorectal Surgery

ILEUS
Start date: December 2015
Phase: Phase 4
Study type: Interventional

Postoperative Ileus is defined as the transient postoperative functional inhibition of propulsive bowel activity. The ethiology of this process can best be described as multifactorial. In its pathogenesis different mechanisms are involved such as hormones and neuropeptides, inflammation, narcotics and the Autonomic nervous system. Is one of the most common causes of prolonged hospital stays after abdominal surgery, thereby increasing health-care resource utilization. More importantly, it causes patient discomfort in the form of nausea, vomiting, and stomach cramps. It has a variable duration but is usually solved in 3 to 4 days. Prolonged Ileus is associated with postoperative complications like an increase on urinary and pulmonary infections, profound venous thrombosis and wound-site complications. Mosapride is a prokinetic agent that acts as a selective serotonin agonist (5- HT4) that facilitates acetylcholine release from the intrinsic plexus. This accelerates gastric emptying and propulsive peristaltic movements on the lower intestines. Mosapride has no action over the central nervous system therefore the lesser side effects like cardiac arrhythmias and extrapyramidal symptoms. For being a safer drug we chose it to be the center of our research. Two randomized controlled trials studied Mosapride concluding it shortens PI after colorectal surgery. However these trials took place on specific populations (Orientals) with less than 50 patients and only one of them included laparoscopic treatment specifically. Also the end point of these studies didn't consider the impact of PI over hospital stay or costs to the health system. We therefore decided to conduct a prospective randomized study in patients undergoing laparoscopic colorectal surgery for colon cancer. The patients will be randomized to receive treatment or placebo after surgery. With this study we intend to prove that patients treated with mosapride immediately after surgery suffer from shorter postoperative ileus with earlier oral intake and shorter hospital stay. The primary aim of the trial is to assess the effectiveness of the use of Mosapride in shortening the duration of the Postoperative ileus in patients undergoing colorectal laparoscopic surgery. The trial hypothesis is that the standardized use of Mosapride immediately after colorectal laparoscopic surgery is safe and accelerates the recovery of propulsive bowel activity, thereby shortening postoperative ileus and hospital stay.

NCT ID: NCT02004652 Completed - Postoperative Ileus Clinical Trials

Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery

Start date: November 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect and safety of prucalopride on recovery of gastrointestinal function in patient undergoing major gastrointestinal surgery. The investigators hypothesize that patients who take prucalopride after major gastrointestinal surgery will have shorter duration of postoperative ileus.

NCT ID: NCT01956643 Completed - Postoperative Ileus Clinical Trials

Effect of Sham Feeding on Postoperative Ileus After Elective Liver Transplantation

Start date: October 2013
Phase: N/A
Study type: Interventional

Postoperative ileus is a common after abdominal surgery. Multifactorial etiology such as surgical trauma, bowel manipulation and perioperative opioids contributes to delayed return of normal gut function Chewing gum has recently been used as a form of sham feeding to stimulate acceleration of gut function after abdominal surgery. The investigators hypothesize that sham feeding with chewing gum will accelerate return of gut function after liver transplantation.

NCT ID: NCT01863407 Recruiting - Postoperative Ileus Clinical Trials

Study of Dexamethasone-Allantoin-Metronidazole (DAM) Solution in the Treatment of Post-Operative Ileus (POI)

Start date: April 2013
Phase: Phase 3
Study type: Interventional

This study is being conducted to determine whether Dexamethasone-Allantoin-Metronidazole (DAM) Solution can accelerate recovery of gastrointestinal function following abdominal operation when compared with a placebo.

NCT ID: NCT01844908 Recruiting - Postoperative Ileus Clinical Trials

Electroacupuncture for Postoperative Ileus After Laparoscopic Rectal Cancer Surgery

Start date: May 2013
Phase: N/A
Study type: Interventional

Postoperative ileus remains a significant medical problem after colorectal surgery that adversely influences patients' recovery. The investigators previous study demonstrated that electroacupuncture (EA) at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of postoperative ileus and hospital stay after laparoscopic resection of colonic and upper rectal cancer. Patients with mid/low rectal cancer undergoing laparoscopic total mesorectal excision (TME) or abdominoperineal resection (APR) were excluded. However, these complex cases are more likely to develop prolonged ileus and morbidity after surgery, and it is uncertain whether EA will be beneficial to them. The investigators therefore propose to conduct a prospective cohort study to evaluate the efficacy of EA in preventing prolonged ileus after laparoscopic surgery for mid/low rectal cancer. Fifty consecutive patients with mid/low rectal cancer undergoing laparoscopic TME or APR without the need of conversion will be recruited. All patients will undergo 1 session (20 minutes) of EA daily from postoperative day 1 till day 4. These patients will be compared with a matched historical control group (1:2) who underwent laparoscopic TME or APR without EA. The primary outcome is the incidence of prolonged ileus, which is defined as the inability to tolerate fluid diet by 4 days after surgery, associated with the need for nasogastric decompression and/or parenteral nutrition support. Secondary outcomes include time to defecation and duration of hospital stay. Results of this study will help clarify the efficacy of EA in preventing prolonged ileus after laparoscopic rectal surgery, and may provide the basis for planning a larger randomized controlled trial.

NCT ID: NCT01835119 Recruiting - Postoperative Ileus Clinical Trials

Influence of Gum Chewing on Postoperative Bowel Activity After Complete Staging Surgery for Gynecological Malignancies

Start date: January 2012
Phase: Phase 4
Study type: Interventional

Postoperative ileus can cause the accumulation of secretions and gas, resulting in nausea, vomiting and abdominal distension and pain. Prolonged paralytic ileus is one of the commonest reasons for delayed recovery and discharge from hospital following abdominal surgery. Advances in surgical techniques and peri-operative management such as the use of laparoscopic surgery, thoracic epidural analgesia, early postoperative feeding and mobilization, amongst others, have been shown to help in the resolution of postoperative ileus. Chewing gum, as a proxy for sham feeding, may accelerate the motility of the GI tract by stimulating the cephalic phase of digestion and eliciting the release of multiple promotility GI hormones. A number of small controlled studies evaluating the effect of chewing gum on postoperative intestinal recovery in patients undergoing colorectal surgery have been conducted. Decreased time for bowel function recovery and decreased hospital length of stay have not been consistently documented, possibly owing to the insufficient power of existing studies and study design issues. In addition, all previous studies have been limited by their use of sugarfree gum, containing known motility agents (eg, sorbitol). In this study, gum chewing was studied for its effect on women with surgical staging for malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancer.

NCT ID: NCT01818375 Completed - Postoperative Ileus Clinical Trials

Goal Directed Fluid Therapy and Postoperative Ileus

Start date: February 2013
Phase: N/A
Study type: Interventional

Despite Goal Directed Fluid Therapy (GDFT) has shown a reduction of hospitalization and overall complications in patients undergoing abdominal surgery, there is a need to address the effect of implementing GDFT on the incidence of specific surgical complications and in a context of en enhanced recovery program (ERP). Specifically, studies investigating the impact of GDFT on primary postoperative ileus (POI) in patients undergoing laparoscopic colorectal surgery and using an ERP are missing. It is hypothesized that the incidence of primary POI will be reduced in patients receiving intraoperative GDFT compared to patients receiving Standard Fluid Therapy (SFT) after elective laparoscopic colorectal surgeries with an ERP program.

NCT ID: NCT01710982 Completed - Postoperative Ileus Clinical Trials

A Study to Evaluate the Safety of TZP-101 (IV Ulimorelin) Administered Post-Operatively in Patients Who Have Undergone Partial Bowel Resection

Start date: February 2012
Phase: Phase 3
Study type: Interventional

A study to evaluate the safety of TZP-101 in comparison with placebo when administered post-operatively in patients who have undergone partial bowel resection.

NCT ID: NCT01699919 Completed - Postoperative Pain Clinical Trials

A Study to Assess Analgesic Efficacy of Intravenous Lignocaine

Start date: April 2011
Phase: Phase 4
Study type: Interventional

The primary objectives of this study are to analyse the effect of perioperative systemic infusion of lignocaine on postoperative pain, postoperative nausea and vomiting and perioperative levels of inflammatory mediators in patients undergoing elective open abdominal surgeries. The secondary parameters which will be observed during the study are the time to passage of flatus and stools postoperatively.

NCT ID: NCT01668199 Completed - Postoperative Ileus Clinical Trials

A Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery and Pharmacokinetics of 14C TZP-101

Start date: February 2012
Phase: Phase 1
Study type: Interventional

A study to investigate the mass balance recovery and pharmacokinetics of 14C TZP-101.