A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler
A Prospective Randomized Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler
1 other identifier
interventional
100
1 country
1
Brief Summary
The most challenge for the surgery of low rectal carcinoma was whether to perform low anterior resection (LAR) and preserve anal function improving the quality of life for patients, for which anastomotic leak is a great obstacle with about 5-10% incidence in reported literature. Up to now, kinds of surgical devices have been employed to reduce anastomotic leak rate after LAR. Most of these anastomotic devices could not resolve the problem of "dog ear" phenomena. In the present clinical trial, the investigators use a double purse-string rectal anastomosis with KOL staple in laparoscopic anterior rectal resection for low or ultra-low rectal carcinoma, which will resolve the problem of dog ear. The investigators aim to demonstrate the safety, effectiveness of this procedure and establish a standard method for laparoscopic (ultra-)low anterior rectal resection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 29, 2015
CompletedFirst Posted
Study publicly available on registry
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMarch 25, 2016
March 1, 2016
3.3 years
September 29, 2015
March 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
anastomotic leak rate
percentage of patients occuring anastomotic leak within 30 days since surgery
30 days since the date of surgery
Secondary Outcomes (2)
post-operative anal function
within one year since the date of surgery
30-day mortality rate
within 30 days since the date of surgery
Study Arms (2)
KOL group
EXPERIMENTALKOL stapler was used for rectal anastomosis
traditional stapler group
ACTIVE COMPARATORtraditional stapler was used for rectal anastomosis
Interventions
Eligibility Criteria
You may qualify if:
- pathological confirmed rectal adenocarcinoma
- less than 10 cm of distal tumor margin from the anal edge
- less than 4 cm of maximum tumor diameter and less than 1/2 of circumference diameter
- tumor stage earlier than cT1-3N0M0 before surgery or that following neoadjuvant radiochemotherapy
- normal defecation function (Wexner score \< 4)
- open or laparoscopic operation
You may not qualify if:
- recurrent cases
- emergency including obstruction, bleeding or perforation
- severe abdominal adhesions
- severe malnutrition can not be improved before surgery
- can not tolerate to surgery due to severe comorbidities of heart, lung, liver or kidney
- refractory hypoproteinemia or diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Related Publications (6)
Midura EF, Hanseman D, Davis BR, Atkinson SJ, Abbott DE, Shah SA, Paquette IM. Risk factors and consequences of anastomotic leak after colectomy: a national analysis. Dis Colon Rectum. 2015 Mar;58(3):333-8. doi: 10.1097/DCR.0000000000000249.
PMID: 25664712BACKGROUNDEspin E, Ciga MA, Pera M, Ortiz H; Spanish Rectal Cancer Project. Oncological outcome following anastomotic leak in rectal surgery. Br J Surg. 2015 Mar;102(4):416-22. doi: 10.1002/bjs.9748. Epub 2015 Jan 26.
PMID: 25619499BACKGROUNDTrencheva K, Morrissey KP, Wells M, Mancuso CA, Lee SW, Sonoda T, Michelassi F, Charlson ME, Milsom JW. Identifying important predictors for anastomotic leak after colon and rectal resection: prospective study on 616 patients. Ann Surg. 2013 Jan;257(1):108-13. doi: 10.1097/SLA.0b013e318262a6cd.
PMID: 22968068BACKGROUNDMorse BC, Simpson JP, Jones YR, Johnson BL, Knott BM, Kotrady JA. Determination of independent predictive factors for anastomotic leak: analysis of 682 intestinal anastomoses. Am J Surg. 2013 Dec;206(6):950-5; discussion 955-6. doi: 10.1016/j.amjsurg.2013.07.017. Epub 2013 Sep 24.
PMID: 24070663BACKGROUNDMirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg. 2011 May;253(5):890-9. doi: 10.1097/SLA.0b013e3182128929.
PMID: 21394013BACKGROUNDRoumen RM, Rahusen FT, Wijnen MH, Croiset van Uchelen FA. "Dog ear" formation after double-stapled low anterior resection as a risk factor for anastomotic disruption. Dis Colon Rectum. 2000 Apr;43(4):522-5. doi: 10.1007/BF02237198.
PMID: 10789750BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Li Xin-Xiang, M.D & Ph.D.
Shanghai Cancer Center, Fudan University, #270 Dong An Road, Shanghai, 200030
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor of colorectal surgery
Study Record Dates
First Submitted
September 29, 2015
First Posted
October 1, 2015
Study Start
September 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
March 25, 2016
Record last verified: 2016-03