Anastomotic Leak, Laparoscopy, Rectal Carcinoma
Conditions
Keywords
Rectal Carcinoma, Laparoscopy, Anastomotic Leak, Double-stapling technique
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.
Interventions
PROCEDUREwithout Dog Ear group
a modified double-stapling technique with eliminating the dogears in laparoscopic anterior resection
PROCEDUREwith Dog Ear group
a traditional double-stapling technique without eliminating the dogears in laparoscopic anterior resection
Sponsors
Fujian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| anastomotic leakage rate | 30 days since the date of surgery |
Secondary
| Measure | Time frame |
|---|---|
| QLQ 30 | at postoperative 3,6 and 12 months |
| Wexner's scoring | at postoperative 3,6 and 12 months |
| 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 |
Contacts
Primary ContactGuo-xian Guan, MD,PhD
Outcome results
None listed