Laparoscopy Clinical Trial
Official title:
Anastomotic Leakage in Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer : A Prospective, Randomized, Controlled Study
The study evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique which to eliminate the 'dog ears' in laparoscopic rectal anterior resection.
Status | Not yet recruiting |
Enrollment | 250 |
Est. completion date | June 2018 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Eligibility rule of enrollment - Rectal adenocarcinoma above the peritoneal reflection - at least 18 years old & at most 80 years old - Clinically diagnosed cT1-T4aN0-2 disease - no contraindication to laparoscopic surgery - without other malignancies in medical history Exclusion Criteria: - concurrent or previous diagnosis of invasive cancer within 5 years - locally advanced cancers requiring en bloc multivisceral resection - intestinal obstruction - intestinal perforation - American Society of Anesthesiologists(ASA) class 4 or 5 - pregnant or breast-feeding women - history of mental disorder - participation in another rectal cancer clinical trial relating to surgical technique |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Fujian Medical University |
Chen ZF, Liu X, Jiang WZ, Guan GX. Laparoscopic double-stapled colorectal anastomosis without "dog-ears". Tech Coloproctol. 2016 Apr;20(4):243-7. doi: 10.1007/s10151-016-1437-3. Epub 2016 Feb 22. — View Citation
Kang J, Lee HB, Cha JH, Hur H, Min BS, Baik SH, Kim NK, Sohn SK, Lee KY. Feasibility and impact on surgical outcomes of modified double-stapling technique for patients undergoing laparoscopic anterior resection. J Gastrointest Surg. 2013 Apr;17(4):771-5. — View Citation
Kim HJ, Choi GS, Park JS, Park SY. Comparison of intracorporeal single-stapled and double-stapled anastomosis in laparoscopic low anterior resection for rectal cancer: a case-control study. Int J Colorectal Dis. 2013 Jan;28(1):149-56. doi: 10.1007/s00384- — View Citation
Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Büchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal b — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | anastomotic leakage rate | 30 days since the date of surgery | Yes | |
Secondary | Intra-operative and post-operative complications | 30 days since the date of surgery | Yes | |
Secondary | post-operative Mortality | 30 days since the date of surgery | Yes | |
Secondary | re-operation rate | 30 days since the date of surgery | Yes | |
Secondary | QLQ 30 | at postoperative 3,6 and 12 months | No | |
Secondary | Wexner's scoring | at postoperative 3,6 and 12 months | No |
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