A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler
NCT ID: NCT02565667
Last Updated: 2016-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-09-30
2018-12-31
Brief Summary
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Detailed Description
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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 importance to develop new surgical devices to prevent "dog ear" problem and reduce the anastomotic leak rate.
Double stapled pursestring anastomosis was the one of the most widely used methods in lower rectal resection. One major problem of this procedure was creating one or double side "dog ear" phenomenon (Dis Colon Rectum. 2000 Apr;43(4):522-5. Fig 1). This weak spot was theoretically responsible for post-operative anastomotic leak as demonstrated by animal experiments and clinical practice.
In this clinical trial, we used a transanal double purse-string rectal anastomosis preformed with KOL stapler for lower rectal resection. This procedure would resolve the dog ear problem through circular anastomosis taking care that the anastomotic site contained only gut tissues without any staples. We aim to demonstrate the safety, effectiveness of this procedure and establish a standard method for laparoscopic (ultra-)low anterior rectal resection.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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KOL group
KOL stapler was used for rectal anastomosis
KOL
KOL staple was used for rectal anastomosis
traditional stapler group
traditional stapler was used for rectal anastomosis
traditional staple
traditional staple was used for rectal anastomosis
Interventions
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KOL
KOL staple was used for rectal anastomosis
traditional staple
traditional staple was used for rectal anastomosis
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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LI XIN-XIANG
professor of colorectal surgery
Principal Investigators
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Li Xin-Xiang, M.D & Ph.D.
Role: STUDY_DIRECTOR
Shanghai Cancer Center, Fudan University, #270 Dong An Road, Shanghai, 200030
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Espin 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.
Trencheva 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.
Morse 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.
Mirnezami 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.
Roumen 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.
Other Identifiers
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FudanKOL
Identifier Type: -
Identifier Source: org_study_id
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