Clinical trial · Interventional
Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer
Anastomotic Leakage in Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer : A Prospective, Randomized, Controlled Study
NCT02770911CI-TRIAL-00022106unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Laparoscopy | — | UNRESOLVED | — |
| Rectal Carcinoma | Rectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| with "Dog Ear" group | Procedure | — | UNRESOLVED |
| without "Dog Ear" group | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- without "Dog Ear" group
- 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.
- interventionNames
- Procedure: without "Dog Ear" group
- type
- ACTIVE_COMPARATOR
- label
- with "Dog Ear" group
- description
- traditional double-stapled anastomosis was used for laparoscopic anterior resection
- interventionNames
- Procedure: with "Dog Ear" group
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (5)
- RESULTRoumen 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. PMID 10789750
- RESULTKang 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. PMID 23288715
- RESULTKim 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. PMID 23014975
- RESULTChen 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. PMID 26902367
- RESULTRahbari 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. PMID 20004450