A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler
Launched by FUDAN UNIVERSITY · Sep 30, 2015
Trial Information
Current as of June 24, 2025
Unknown status
Keywords
ClinConnect Summary
About 5-10% of patients receiving low rectal resection using traditional anastomosis occurred anastomotic leak, risk factors for which included patient related (age, gender, tumor distance from the anal verge), hypoproteinemia, diabetes mellitus, etc), procedure related (emergency) and technical related (one stapler, double stapler or handsewn).
Anastomotic leak caused prolonged hospital stay, delayed post-operative adjuvant radiochemotherapy and need of stoma in some cases. Besides, anastomotic leak was reported to be associated with increased local recurrence rate. Thus, it's of great im...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. pathological confirmed rectal adenocarcinoma
- • 2. less than 10 cm of distal tumor margin from the anal edge
- • 3. less than 4 cm of maximum tumor diameter and less than 1/2 of circumference diameter
- • 4. tumor stage earlier than cT1-3N0M0 before surgery or that following neoadjuvant radiochemotherapy
- • 5. normal defecation function (Wexner score \< 4)
- • 6. open or laparoscopic operation
- Exclusion Criteria:
- • 1. recurrent cases
- • 2. emergency including obstruction, bleeding or perforation
- • 3. severe abdominal adhesions
- • 4. severe malnutrition can not be improved before surgery
- • 5. can not tolerate to surgery due to severe comorbidities of heart, lung, liver or kidney
- • 6. refractory hypoproteinemia or diabetes mellitus
About Fudan University
Fudan University, a prestigious comprehensive research university located in Shanghai, China, is committed to advancing medical science through innovative clinical research. Renowned for its rigorous academic standards and cutting-edge research facilities, Fudan University plays a pivotal role in the global health landscape by sponsoring a diverse array of clinical trials aimed at improving patient outcomes and addressing pressing medical challenges. Leveraging its multidisciplinary expertise and collaborative networks, the university strives to translate scientific discoveries into practical applications, fostering advancements in healthcare and contributing to the well-being of communities both locally and internationally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Patients applied
Trial Officials
Li Xin-Xiang, M.D & Ph.D.
Study Director
Shanghai Cancer Center, Fudan University, #270 Dong An Road, Shanghai, 200030
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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