Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: without "Dog Ear" group 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. |
Procedure: without "Dog Ear" group
a modified double-stapling technique with eliminating the dogears in laparoscopic anterior resection
Other Names:
|
| Active Comparator: with "Dog Ear" group traditional double-stapled anastomosis was used for laparoscopic anterior resection |
Procedure: with "Dog Ear" group
a traditional double-stapling technique without eliminating the dogears in laparoscopic anterior resection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- anastomotic leakage rate [30 days since the date of surgery]
Secondary Outcome Measures
- Intra-operative and post-operative complications [30 days since the date of surgery]
- post-operative Mortality [30 days since the date of surgery]
- re-operation rate [30 days since the date of surgery]
- QLQ 30 [at postoperative 3,6 and 12 months]
- Wexner's scoring [at postoperative 3,6 and 12 months]
Eligibility Criteria
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
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no contraindication to laparoscopic surgery
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without other malignancies in medical history
Exclusion Criteria:
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concurrent or previous diagnosis of invasive cancer within 5 years
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locally advanced cancers requiring en bloc multivisceral resection
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intestinal obstruction
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intestinal perforation
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American Society of Anesthesiologists(ASA) class 4 or 5
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pregnant or breast-feeding women
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history of mental disorder
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participation in another rectal cancer clinical trial relating to surgical technique
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Fujian Medical University
Investigators
- Principal Investigator: Guo-xian Guan, MD,PhD, Fujian Medical University Union Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FJMU-20160424