Search Clinical Trials
By Condition
By Location (USA)
By Location (Other)
By Sponsor
Resources
Privacy Policy
About Us
Disclaimer
J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma Clinical research trials and J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma. J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma clinical trial. Human subjects often obtain the finest healthcare possible for their J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.

Home > "J" Clinical Trials Conditions > J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma

J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma



J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma

For Condition: stage 3 rectal cancer,stage 1 rectal cancer,perioperative/postoperative complications,stage 2 rectal cancer,adenocarcinoma of the rectum
Status: Recruiting
Sponsor(s): Academisch Medisch Centrum ,
Synopsis: RATIONALE: A coloanal anastomosis may be effective in restoring bowel function after radiation therapy and surgery to remove the rectum. It is not yet known whether a J-pouch coloanal anastomosis is more effective than a side-to-end anastomosis in restoring bowel function in patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum. PURPOSE: Randomizedphase III trial to compare the effectiveness of J-pouch coloanal anastomosis with that of side-to-end coloanal anastomosis in treating patients with rectal adenocarcinoma who have undergone radiation therapy and surgery to remove the rectum.
Details: OBJECTIVES: Primary - Compare functional outcome in patients with mid- or distal rectal adenocarcinoma when treated with J-pouch coloanal anastomosis vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision. Secondary - Compare the quality of life of patients treated with these procedures. - Compare anorectal function in patients treated with these procedures. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and gender. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo total mesorectal excision followed by a J-pouch coloanal anastomosis. - Arm II: Patients undergo total mesorectal excision followed by a side-to-end coloanal anastomosis. In both arms, patients receive a temporary ileostomy. The ileostomy is closed after 1 week provided recovery is uneventful and no radiological signs of anastomotic leakage are detected. If early closure is not possible, the ileostomy is closed after 6-8 weeks. Functional outcome, quality of life, and anorectal function are assessed before surgery and at 4 and 12 months after surgery. PROJECTED ACCRUAL: A minimum of 100 patients (50 per treatment arm) will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the rectum - T2 or T3 disease - Disease located in the mid- or distal rectum - No evidence of metastatic disease - No preexisting grade III or IV incontinence - Completed preoperative radiotherapy (5 x 5 Gy) before study entry PATIENT CHARACTERISTICS: Age - Over 18 Performance status - WHO 0-2 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Working knowledge of the Dutch language PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior radiotherapy to the pelvis Surgery - No prior colon resection - No prior anorectal surgery - No concurrent abdominoperineal resection
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
R.Bakx,  Study Chair,  Academisch Medisch Centrum

Gelre Ziekenhuizen - Lokatie Lukas *Recruiting*
Apeldoorn,  ,  7334 DZ
Netherlands
Recruiting W.  Lastdrager 31-555-81-8181

Reinier de Graaf Group *Recruiting*
Delft,  ,  NL 2600 GA
Netherlands
Recruiting Tom  Karsten 31-15-260-3060

Onze Lieve Vrouwe Gasthuis *Recruiting*
Amsterdam,  ,  1091 HA
Netherlands
Recruiting L.  De Wit 31-20-599-9111

Albert Schweitzerziekenhuis - Locatie Amstelwijck *Recruiting*
Dordrecht NM,  ,  NL-3317
Netherlands
Recruiting R.  Oostenbroek 31-78-654-1111

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital *Recruiting*
Amsterdam,  ,  1066 CX
Netherlands
Recruiting F.A.  Zoetmulder 31-20-512-9111

St. Lucas - Andreas Ziekenhuis *Recruiting*
Amsterdam,  ,  1091 AE
Netherlands
Recruiting W.  Van Tets 31-20-510-8911

Academisch Medisch Centrum *Recruiting*
Amsterdam,  ,  1105 AZ
Netherlands
Recruiting R.  Bakx 31-20-566-3405

Isala Klinieken - locatie Sophia *Recruiting*
Zwolle,  ,  8000 GK
Netherlands
Recruiting A.  Dalsen 31-38-424-5000

Isala Klinieken - locatie Weezenlanden *Recruiting*
Zwolle,  ,  NL-8000 GM
Netherlands
Recruiting D.  Geldere 31-38-424-2000


Additional Information:
Study ID Numbers:
  CDR0000328269;  EU-20247,CKTO-2002-02-POCASTER
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070005

Other Adenocarcinoma Of The Rectum Studies:
1. J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma

2. Surgery With or Without Chemotherapy and Radiation Therapy in Treating Patients With Stage I Rectal Cancer

3. Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed

4. Lymph Node Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I, Stage II, or Stage III Colorectal Cancer

5. Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer

Related Studies:

Other adenocarcinoma of the rectum Clinical Trials
Other Clinical Trials
Other Amsterdam Clinical Trials

J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma

Modify your Search

  Other adenocarcinoma of the rectum Clinical Trials
  Other Clinical Trials
  Other Amsterdam Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103