HOME  | CONTACT  | PATIENT LOGIN  | CLINIC LOGIN  | FAQ
  • PATIENTS &
    HEALTHY VOLUNTEERS
  • INVESTIGATORS
  • CROS / SPONSORS
  • CAREERS
  • TRIAL ALERTS

TRIALS SEARCH
      
  • HEALTH NEWS

  • RSS FEEDS

  • ABOUT TRIALS

  • LINK TO US


View Clinical Trial (Medical Research Study)


A Multicenter Prospective Randomized Study Comparing Hand Assisted Versus "Pure" Laparoscopic Assisted Proctectomy for Rectal Cancer

Signup
Browse Studies

City:   New York
State:   New York
Zip Code:   10021
Conditions:   Rectal Cancer
Purpose:   We hypothesize that hand-assisted laparoscopy will overcome technical difficulties related to pure laparoscopic rectal surgery and allow surgeons to expand application of laparoscopic techniques to treating patients with rectal cancer. In this study, we plan to randomly assign patients diagnosed with rectal cancer to undergo either "standard" laparoscopic surgery or hand-assisted laparoscopic surgery. We will then compare both peri-operative and long-term outcomes of patients.
Study Summary:   Compared to traditional open surgery, laparoscopic surgery for colon cancer results in short-term benefits such as less pain, shorter length of stay, and faster return of bowel function while maintaining equivalent oncologic outcomes. For this reason, increasing numbers of colon cancer patients are undergoing laparoscopic surgery.1-3 Similarly, there are many potential benefits to performing rectal surgery laparoscopically. Although not well documented, laparoscopic rectal surgery is under active study and may result in the usual short-term benefits associated with laparoscopic surgery. In addition, compared to open surgery, laparoscopy can provide unprecedented, unobstructed views of the rectal dissection planes even in a patient with narrow pelvis, not only for the surgeon but to the entire surgical team. Magnified views of the surgical planes allow precise and sharp dissection. The pneumoperitoneum can also help open the planes for mobilization of the mesorectum. Despite these potential advantages, adoption of laparoscopic rectal surgery has been limited for many reasons. Although there are now several prospective randomized trials demonstrating safety and benefits associated with laparoscopic colon cancer surgery, the same benefits have not yet been clearly demonstrated for laparoscopic rectal cancer surgery.1-3 In addition, concerns about inadequate oncologic rectal dissection, anastomotic complications, and technical challenges have limited wide adaptation of laparoscopic rectal surgery.4,5 In efforts to retain the benefits of laparoscopic surgery while not compromising oncologic rectal dissection, others have advocated performing hybrid procedures in which colonic portion of the surgery is performed using the "pure" laparoscopic technique and rectal dissection is performed open through a limited low midline or Pfannestiel (low transverse) incision.6 Hand-assisted laparoscopic surgery is a technique in which the surgeon places a hand into the abdomen through an airtight access device while performing laparoscopic surgery. By placing a hand into the abdomen during laparoscopy, surgeons retain their abilities to manually retract, expose, and manually dissect, which are lost in pure laparoscopic surgery. Retention of these abilities can significantly expedite the operation. In fact, several studies have demonstrated that hand-assisted laparoscopic colon surgery results in significantly shorter operative time and less conversion to open surgery while maintain similar short-term outcomes compared to "pure" laparoscopic technique.7-9 In rectal surgery for cancer, sigmoid colon, left colon, and splenic flexure need to be mobilized in order to allow tension free anastomosis between the colon and the residual rectum. In laparoscopic proctectomy, HALS compared to SLS technique may therefore, result in shorter operative time based on colonic portion of the operation alone. One of the technical hurdles in performing laparoscopic rectal dissection is exposure and retraction of the rectum. As one dissects down to the distal rectum, especially in patients with narrow pelvis, crowding and clashing of instruments can result in poor exposure and dissection. The only prospective randomized trial comparing results of open vs. laparoscopic surgery to include rectal cancer is CLASICC trial.3 It reported an increased circumferentially positive margin of cancer following laparoscopic rectal resection with twice as many patients in the laparoscopic group (12 %) having an involved margin as in the open group (6 %). This increased radial margin may be related to difficulty in retraction and exposure. In HALS, rectal exposure and dissection can be either performed directly through the incision using the open techniques or laparoscopically with manual assistance. This may result in equivalent oncologic outcomes as the open surgery but with shorter operative time compared to SLS technique. A further challenge in laparoscopic rectal surgery is localization of the tumor, which is less of an issue in colon cancer where the tumor is easily visible or tattooed preoperatively. This is not possible for rectal cancer, which can pose a problem in both dissection and safe division of the rectum. Without tactile sensation it can be difficult to be sure that the stapler is below the tumor. Hand assisted laparoscopic surgery allows preservation of tactile sensation and therefore circumvent the above problem. The next step following mobilization of the rectum is division of the rectum and anastomosis. This poses a challenge for the laparoscopic surgeon for several reasons. The current laparoscopic stapling devices angulate to a maximum of 65 o making horizontal division of the rectum difficult. Morin et al reported a leak rate of 17 % below 12 cm from the anal verge and as high as 25 % in those who were not diverted following laparoscopic rectal surgery.4 Leroy et al reported a similar leak rate of 20 % in cancers below 15 cm following laparoscopic rectal surgery.5 Comparatively higher leak rates after laparoscopic rectal surgery may be related to limitations in currently available laparoscopic surgical staplers. By performing distal rectal division through the incision by using the open surgical staplers, hand-assisted laparoscopic rectal surgery may result in lower anastomotic leakage rate. We hypothesize that hand-assisted laparoscopy may result in shorter operative time while retaining the benefits associated with laparoscopic surgery. In this study, we plan to randomly assign patients diagnosed with rectal cancer to undergo either "standard" laparoscopic surgery or hand-assisted laparoscopic surgery. We will then compare both peri-operative and long-term outcomes of patients. If our hypothesis is true, hand assisted laparoscopic approach to rectal surgery may be preferable to standard laparoscopic surgery.
Criteria:   Inclusion Criteria: - Age > = 18 years of age - Histologically proven rectal cancer - Inferior margin of the cancer located within 15 cm from the anal verge as determined by rigid sigmoidoscopy - No evidence of distant metastases - Childbearing age women with negative pregnancy test - Patient is a candidate for elective rectal resection - The patient, or their representative, is able to understand the study and is willing to consent to participation in the study. Exclusion Criteria: - Age < 18 years of age - Surgically unresectable rectal cancer - Patients who will require APR or hand-sewn colo-anal anastomosis - ASA class 4 or 5 - Patients having additional surgical procedures which may have affect recovery - Child bearing age women with positive pregnancy test - Patients with contraindication for treatment by laparoscopy - Patients or their representative who are unable to understand the conditions and objectives of the study
NCT ID:   NCT00651677
Primary Contact:   Principal Investigator
Sang W Lee, MD
Weill Medical College of Cornell University

Sang W Lee, MD
Phone: 212-746-6030
Email: sal2013@med.cornell.edu
Backup Contact:   Email: kivanova@med.cornell.edu
Koiana Trencheva, BSN,M.S.
Phone: 212-746-5241
Location Contact:   New York, New York 10021
United States

Sang W Lee, MD
Phone: 212-746-6030
Email: sal2013@med.cornell.edu

Site Status: Recruiting

Data Source:   ClinicalTrials.gov
Date Processed:   May 23, 2013
Modifications to this listing:   Only selected fields are shown, please use the link below to view all information about this clinical trial.
Click to view Full Listing


If you would like to be contacted by the clinical trial representative please enter your contact information, then click "I Am Interested In This Study"
First Name:  
Last Name:  
Email Address:  
Confirm Email:    
Daytime Phone (eg. 555-555-5555):  
City:  
State:
Zip Code:    
Best Time to Call:  
Questions/Comments:  
  • NEARBY STUDIES

Within 25 Miles

Post-Herpetic Neuralgia (PHN) (Post-Shingles Pain) - New York NY (Clinical Trial 3231)

Major Depressive Disorder - New York NY

Depression - New York NY

Social Anxiety Disorder - New York NY

Depression - New York NY

Bipolar Depression - New York NY

Gout - New York NY

Crohn's Disease - Great Neck NY

Diabetic Foot Pain - New York NY

Generalized Anxiety Disorder - New York NY

Depression - New York NY

Irritable Bowel Syndrome with Diarrhea (IBS-D) - Great Neck NY

Irritable Bowel Syndrome with Diarrhea (IBS-D) - Great Neck NY

Crohn's Disease - Great Neck NY

Arthritis - Hartsdale NY

Gout - New York NY

Dry Eye - Wantagh NY

Irritable Bowel Syndrome (with diarrhea) - New York NY

Lower Back Pain - New York NY

Depression - New York NY

Postherpetic Neuralgia (Post-shingles pain) - New York NY

Chronic Low Back Pain - Great Neck NY

Multiple Myeloma, Mantle Cell Lymphoma, Diffuse Large B Cell Lymphoma - Hackensack NJ

Arthritis - Roslyn NY

Treatment Resistant Depression - New York NY

Irritable Bowel Syndrome with Diarrhea (IBS-D) - New York NY

Low Back Pain and Constipation - New York NY

Low Back Pain and Constipation - Staten Island NY

Low Back Pain and Constipation - Great Neck NY

Low Back Pain and Constipation - Cedarhurst NY

Anti-Depressant Induced Sexual Dysfunction - New York NY

Anti-Depressant Induced Sexual Dysfunction - Staten Island NY

Anti-Depressant Induced Sexual Dysfunction - Staten Island NY

Irritable Bowel Syndrome (with diarrhea) - Kew Gardens NY

Irritable Bowel Syndrome (with diarrhea) - Hartsdale NY

Acne - New York NY

Uncontrolled Angina (Adult Stem Cell Research) - Newark NJ

Uncontrolled Angina (Adult Stem Cell Research) - New York NY

Brain Tumor (Glioblastoma) - Hackensack NJ

Brain Tumor (Glioblastoma) - West Harrison NY

Eating Disorder - Jamaica NY

COPD (Emphysema and Chronic Bronchitis) - Summit NJ

COPD (Emphysema and Chronic Bronchitis) - Great Neck NY1

COPD (Emphysema and Chronic Bronchitis) - Brooklyn NY 2

COPD (Emphysema and Chronic Bronchitis) - Great Neck NY2

COPD (Emphysema and Chronic Bronchitis) - New York NY

Depression - New York NY

Acne Vulgaris - Bronx NY

Symptomatic Orthostatic Hypotension (Low Blood Pressure Upon Standing) - Hackensack NJ

Within 50 Miles

Prostate Cancer - Goshen NY

Vaginal Dryness - Plainsboro NJ

Pediatric Depression - Mount Kisco NY

Asthma - Danbury CT

Endometriosis - Danbury CT

Arthritis - Edison NJ

Dry Eye - Danbury CT

Irritable Bowel Syndrome (with diarrhea) - Norwalk CT

Irritable Bowel Syndrome (with diarrhea) - Stamford CT

Irritable Bowel Syndrome (with diarrhea) - New Windsor NY

Chronic Low Back Pain - Stamford CT

Non-Hodgkin's Lymphoma - Mount Kisco NY

Prostate Cancer - Mount Kisco NY

Breast Cancer - Mount Kisco NY

Low Back Pain and Constipation - New Windsor NY

Myelodysplastic Syndrome - Mount Kisco NY

Within 100 Miles

Prostate Cancer - Bethlehem PA

Crohn's Disease - Hamden CT

Crohn's Disease - Poughkeepsie NY

Contraceptive Gel - Philadelphia PA

Bipolar Disorder - Media PA

Endometriosis - Philadelphia PA

Bipolar Disorder - Media PA

Schizophrenia - Norristown PA

Emphysema/COPD (Chronic Obstructive Pulmonary Disease) - Philadelphia PA

Obsessive Compulsive Disorder (OCD) - Norristown PA

HPV - Philadelphia PA

Irritable Bowel Syndrome with Diarrhea (IBS-D) - Waterbury CT

Arthritis - Toms River NJ

Arthritis - Norristown PA

Bipolar Disorder - Cherry Hill NJ

Depression - Cherry Hill NJ

Gout - Jenkintown PA

Excessive Daytime Sleepiness with Narcolepsy - Philadelphia PA

Arthritis - Bristol CT

Restless Legs Syndrome (RLS) - Philadelphia PA

Restless Legs Syndrome (RLS) - Toms River NJ

Dry Eye - Philadelphia PA

Irritable Bowel Syndrome (with diarrhea) - Poughkeepsie NY

Irritable Bowel Syndrome (with diarrhea) - Philadelphia PA

Irritable Bowel Syndrome (with diarrhea) - Lansdale PA

Postherpetic Neuralgia (Post-shingles pain) - Toms River NJ

Arthritis - Sicklerville NJ

Multiple Sclerosis - Philadelphia PA

Asthma (Ages 18-65) - Chester PA

Asthma (Ages 18-65) - Collegeville PA

Gout - Milford CT

Low Back Pain and Constipation - Waterbury CT

Low Back Pain and Constipation - Toms River NJ

Low Back Pain and Constipation - Jenkintown PA

Low Back Pain and Constipation - Levittown PA

Low Back Pain and Constipation - Philadelphia PA

Low Back Pain and Constipation - Phoenixville PA

Anti-Depressant Induced Sexual Dysfunction - Willingboro NJ

Anti-Depressant Induced Sexual Dysfunction - Toms River NJ

Anti-Depressant Induced Sexual Dysfunction - Allentown PA

Anti-Depressant Induced Sexual Dysfunction - Philadelphia PA

Irritable Bowel Syndrome (with diarrhea) - Voorhees NJ

Irritable Bowel Syndrome (with diarrhea) - Jenkintown PA

Obsessive Compulsive Disorder (OCD) - Norristown PA

Obsessive Compulsive Disorder (OCD) - New Haven CT

Arthritis - Hamden CT

Uncontrolled Angina (Adult Stem Cell Research) - Haddon Heights NJ

Uncontrolled Angina (Adult Stem Cell Research) - Philadelphia PA

Asthma (Ages 18-65) - Feasterville PA

Brain Tumor (Glioblastoma) - Philadelphia PA

Arthritis - Feasterville Trevose PA

Anxiety - Cherry Hill NJ

COPD (Emphysema and Chronic Bronchitis) - Marlton NJ

COPD (Emphysema and Chronic Bronchitis) - Phoenixville PA

 
Clinical Connections Home | Investigators | CROs / Sponsors | Clinical Trials Notification | Search Clinical Trials | About Clinical Trials | Links | Terms And Conditions | Sitemap | Suggestions / Feedback
© 1998-2013 | All trademarks are property of their legal owners. | All Rights Reserved

ClinicalConnection.com is a resource that provides individuals with information regarding clinical trials that are being conducted worldwide.

ClinicalConnection.com does not conduct these clinical trials nor endorse them. Please consult your doctor or physician before participating.