Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer
Primary Purpose
Rectal Carcinoma, Laparoscopy, Anastomotic Leak
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
without "Dog Ear" group
with "Dog Ear" group
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Carcinoma focused on measuring Rectal Carcinoma, Laparoscopy, Anastomotic Leak, Double-stapling technique
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
without "Dog Ear" group
with "Dog Ear" group
Arm Description
Before anastomosis, the surgeon made a laparoscopic suturing on the two dog ears by using 3-0 monofilament sutures, and pull two dogears of staple line around the trocar by a tied suture through two dog ears. By this way, the staple line was kept within the circular knife when the circular stapler was closed. Then a true end-to-end anastomosis was performed after stapler firing.
traditional double-stapled anastomosis was used for laparoscopic anterior resection
Outcomes
Primary Outcome Measures
anastomotic leakage rate
Secondary Outcome Measures
Intra-operative and post-operative complications
post-operative Mortality
re-operation rate
QLQ 30
Wexner's scoring
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02770911
Brief Title
Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer
Official Title
Anastomotic Leakage in Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer : A Prospective, Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Laparoscopic surgeons commonly make rectal transection intracorporeally by laparoscopic linear stapler during rectal anterior resection and perform an end-to-end anastomosis by circular stapler. But the so-called 'dog ears', two stapled corners of the rectal stump after laparoscopic linear transection of rectum, are very common. The lateral intersections of double-stapled anastomoses are structural weak spot area, and they are considered to be the potential ischemic areas leading to anastomosis leakage and the possible sites occurring local recurrence. Previous study reported a modified technique for rectal reconstruction during open surgery, and they could use circular stapler to eliminate the staple line on the rectal stump and cut off the 'dog ears'. But because of the narrow pelvic cavity, it is very difficult to perform this technique in laparoscopic rectal surgery and there is no related report on laparoscopic application. In this study, we evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique, to eliminate the "dog ears" in laparoscopic rectal anterior resection by laparoscopic suturing on the staple line.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Carcinoma, Laparoscopy, Anastomotic Leak
Keywords
Rectal Carcinoma, Laparoscopy, Anastomotic Leak, Double-stapling technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
without "Dog Ear" group
Arm Type
Experimental
Arm Description
Before anastomosis, the surgeon made a laparoscopic suturing on the two dog ears by using 3-0 monofilament sutures, and pull two dogears of staple line around the trocar by a tied suture through two dog ears. By this way, the staple line was kept within the circular knife when the circular stapler was closed. Then a true end-to-end anastomosis was performed after stapler firing.
Arm Title
with "Dog Ear" group
Arm Type
Active Comparator
Arm Description
traditional double-stapled anastomosis was used for laparoscopic anterior resection
Intervention Type
Procedure
Intervention Name(s)
without "Dog Ear" group
Other Intervention Name(s)
modified laparoscopic double-stapled anastomosis
Intervention Description
a modified double-stapling technique with eliminating the dogears in laparoscopic anterior resection
Intervention Type
Procedure
Intervention Name(s)
with "Dog Ear" group
Other Intervention Name(s)
traditional laparoscopic double-stapled anastomosis
Intervention Description
a traditional double-stapling technique without eliminating the dogears in laparoscopic anterior resection
Primary Outcome Measure Information:
Title
anastomotic leakage rate
Time Frame
30 days since the date of surgery
Secondary Outcome Measure Information:
Title
Intra-operative and post-operative complications
Time Frame
30 days since the date of surgery
Title
post-operative Mortality
Time Frame
30 days since the date of surgery
Title
re-operation rate
Time Frame
30 days since the date of surgery
Title
QLQ 30
Time Frame
at postoperative 3,6 and 12 months
Title
Wexner's scoring
Time Frame
at postoperative 3,6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guo-xian Guan, MD,PhD
Phone
86-13609592321
Email
gxguan1108@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guo-xian Guan, MD,PhD
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
10789750
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. doi: 10.1007/BF02237198.
Results Reference
result
PubMed Identifier
23288715
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. doi: 10.1007/s11605-012-2122-0. Epub 2013 Jan 4.
Results Reference
result
PubMed Identifier
23014975
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/s00384-012-1582-8. Epub 2012 Sep 27.
Results Reference
result
PubMed Identifier
26902367
Citation
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. No abstract available.
Results Reference
result
PubMed Identifier
20004450
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, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.
Results Reference
result
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Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer
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