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Colorectal Surgery clinical trials

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NCT ID: NCT01196494 Terminated - Colorectal Surgery Clinical Trials

Study of Intraoperative Colonic Irrigation Versus Stent Placement in Obstructive Left-Sided Colonic Cancer

Start date: n/a
Phase: N/A
Study type: Interventional

INTRODUCTION: There are several alternatives for one-stage emergency treatment of obstructive left-sided colonic cancer (OLCC): subtotal colectomy, intraoperative colon lavage (IOCL) with primary anastomosis, and the placement of a stent as a temporary measure prior to scheduled surgery. At present, it is not clear whether emergency perioperative lavage or the placement of a stent is the better technique. The hypothesis is that IOCL and primary anastomosis is equal safe or even safer than placement of a stent as a temporary measure prior to scheduled surgery, less length of stay and less cost. OBJECTIVE: To establish which of these two techniques is more efficient in OLCC from the point of view of morbimortality, economic cost, and long-term survival. MATERIAL AND METHODS: Prospective, controlled, randomized study of patients diagnosed with OLCC. Patients were divided into two groups: group 1: stent and deferred surgery; group 2: emergency IOCL. A simple randomization system was used. The estimated sample size required per group was 21 patients. Demographic variables, risk prediction models, postoperative morbimortality, staging, complications due to the placement of stent, surgical time, clinical follow-up, health costs and follow-up of survival were recorded.

NCT ID: NCT01091155 Completed - Colorectal Surgery Clinical Trials

COMPRES - COMpression Anastomosis Ring (CAR™ 27/ColonRing™) Post maRketing Evaluation Study

COMPRES
Start date: March 2010
Phase: Phase 4
Study type: Interventional

The performance of the ColonRing™ will be comparable to or better than the reported performance of staplers.

NCT ID: NCT01049971 Completed - Colorectal Surgery Clinical Trials

REDWIL: Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors

REDWIL
Start date: December 2007
Phase: N/A
Study type: Interventional

Surgical site infection is common in colorectal surgery leading to increased postoperative pain, longer hospital stay, delayed wound healing and increased re-operation rates. Hence, reducing the wound infection rate is a major aim in abdominal surgery. Wound protectors were invented for retracting the abdominal wall and keeping the abdominal wall sterile in order to reduce bacterial colonialization of the wound and wound infections. This is a prospective-randomized trial comparing use of wound protectors versus woven drapes in laparoscopic colon resections with minilaparotomy.

NCT ID: NCT00953784 Completed - Colorectal Surgery Clinical Trials

Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery

Start date: April 2007
Phase: N/A
Study type: Interventional

This is a comparison, at this VA Hospital, of standard operating room management in colorectal surgery to a more rigid management using an additional five previously tested treatments to determine if this changes the rate of post operative wound infections.

NCT ID: NCT00884130 Completed - Colorectal Surgery Clinical Trials

Cost Effectiveness of Laparoscopic Colorectal Surgery

Start date: January 2006
Phase: N/A
Study type: Observational

Hypothesis: The total costs of laparoscopic colorectal surgery are less than those of open surgery. Secondary hypothesis: Patients quality of life is higher following laparoscopic surgery, as compared to open colorectal surgery. Research objectives: 1. To estimate the cost implications and clinical benefits of incorporating laparoscopic colorectal surgery into routine clinical practice. 2. To examine whether the increased operative costs of laparoscopic surgery are compensated for by a faster recovery, shorter duration of hospital stay, and a reduction in late complications, as compared to open surgery. 3. To investigate whether there are differences in quality of life following laparoscopic colorectal surgery as compared to open surgery. Lay summary: Patients needing an operation for a bowel problem have traditionally had an open operation with an incision on the abdomen, and this is the type of operation that is currently performed in the majority of cases in the United Kingdom today (over 90%). Laparoscopic (or keyhole) surgery has been introduced into bowel surgery, but is currently not widely performed. This is because thus far there have been no clear-cut benefits demonstrated with this technique and the perceived costs are higher than an open operation. The investigators aim to evaluate both of these issues.

NCT ID: NCT00880984 Completed - Colorectal Surgery Clinical Trials

Compression Anastomosis Using the Compression Anastomosis Ring (CAR™ 27)

Start date: June 2008
Phase: N/A
Study type: Interventional

Purpose: Evaluation of the CAR™ 27 for the creation of compression anastomoses. Indication: Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection. Study Design: Prospective, open labeled study. Patient Population: Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon. No. of Subjects: 15 patients estimated up to three months to enroll. Duration of Treatment: During the operation - creation of the anastomosis. Duration of Follow-up: Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months. Endpoints: To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CAR™ 27 device.

NCT ID: NCT00878241 Completed - Colorectal Surgery Clinical Trials

Compression Anastomosis Using the CAR™ 27

Start date: June 2008
Phase: N/A
Study type: Interventional

Purpose: Evaluation of the CAR™ 27 for the creation of compression anastomoses. Indication: Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection. Study Design: Prospective, open labeled study. Patient Population: Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon. No. of Subjects: 15 patients estimated up to three months to enroll. Duration of Treatment: During the operation - creation of the anastomosis. Duration of Follow-up: Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months. Endpoints: To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CAR™ 27 device.

NCT ID: NCT00868400 Completed - Colorectal Surgery Clinical Trials

Clinical Value of Preoperative Oral Carbohydrate Loading in Colorectal Surgery

Start date: May 2009
Phase: N/A
Study type: Interventional

The aim of this study is to provide conclusive clinical evidence as to whether or not the preoperative administration of oral carbohydrate-rich solutions is effective on the outcomes of patients undergoing colorectal surgery.

NCT ID: NCT00867958 Completed - Colorectal Surgery Clinical Trials

Compression Anastomosis Using the CAR™ 27

Start date: September 2008
Phase: N/A
Study type: Interventional

Purpose: Evaluation of the CAR™ 27 for the creation of compression anastomoses. Indication: Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection. Study Design: Prospective, open labeled study. Patient Population: Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon. No. of Subjects: 15 patients estimated up to three months to enroll. Duration of Treatment: During the operation - creation of the anastomosis. Duration of Follow-up: Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months. Endpoints: To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CAR™ 27 device.

NCT ID: NCT00773981 Recruiting - Colorectal Surgery Clinical Trials

Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection

Start date: October 2008
Phase: Phase 3
Study type: Interventional

Anastomotic leakage is a major and potentially mortal complication with an incidence of 10-13% after resection of the rectum. For patients showing no clinical signs of peritonitis, the traditional method has been a conservative treatment with transrectal rinsing. This treatment is often associated with a very protracted postoperative course with healing times of up to a year or more for the anastomotic leakage. Treatment with vacuum drainage (VD) is a new method primarily developed for wound therapy. The objective of this study is to investigate the effects of transrectal vacuum treatment on the healing of anastomotic leakage after rectum resection in a prospective, randomized, controlled multicentre trial in 60 patients found to develop clinically significant anastomotic leakages after elective rectal resection.