Clinical trial · Interventional
A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler
A Prospective Randomized Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler
- 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 most challenge for the surgery of low rectal carcinoma was whether to perform low anterior resection (LAR) and preserve anal function improving the quality of life for patients, for which anastomotic leak is a great obstacle with about 5-10% incidence in reported literature. Up to now, kinds of surgical devices have been employed to reduce anastomotic leak rate after LAR. Most of these anastomotic devices could not resolve the problem of "dog ear" phenomena. In the present clinical trial, the investigators use a double purse-string rectal anastomosis with KOL staple in laparoscopic anterior rectal resection for low or ultra-low rectal carcinoma, which will resolve the problem of dog ear. The investigators aim to demonstrate the safety, effectiveness of this procedure and establish a standard method for laparoscopic (ultra-)low anterior rectal resection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KOL | Device | — | UNRESOLVED |
| traditional staple | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KOL group
- description
- KOL stapler was used for rectal anastomosis
- interventionNames
- Device: KOL
- type
- ACTIVE_COMPARATOR
- label
- traditional stapler group
- description
- traditional stapler was used for rectal anastomosis
- interventionNames
- Device: traditional staple
Primary outcomes (1)
- measure
- anastomotic leak rate
- timeFrame
- 30 days since the date of surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. pathological confirmed rectal adenocarcinoma 2. less than 10 cm of distal tumor margin from the anal edge 3. less than 4 cm of maximum tumor diameter and less than 1/2 of circumference diameter 4. tumor stage earlier than cT1-3N0M0 before surgery or that following neoadjuvant radiochemotherapy 5. normal defecation function (Wexner score \< 4) 6. open or laparoscopic operation Exclusion Criteria: 1. recurrent cases 2. emergency including obstruction, bleeding or perforation 3. severe abdominal adhesions 4. severe malnutrition can not be improved before surgery 5. can not tolerate to surgery due to severe comorbidities of heart, lung, liver or kidney 6. refractory hypoproteinemia or diabetes mellitus
References
Publications (6)
- BACKGROUNDMidura EF, Hanseman D, Davis BR, Atkinson SJ, Abbott DE, Shah SA, Paquette IM. Risk factors and consequences of anastomotic leak after colectomy: a national analysis. Dis Colon Rectum. 2015 Mar;58(3):333-8. doi: 10.1097/DCR.0000000000000249. PMID 25664712
- BACKGROUNDEspin E, Ciga MA, Pera M, Ortiz H; Spanish Rectal Cancer Project. Oncological outcome following anastomotic leak in rectal surgery. Br J Surg. 2015 Mar;102(4):416-22. doi: 10.1002/bjs.9748. Epub 2015 Jan 26. PMID 25619499
- BACKGROUNDTrencheva K, Morrissey KP, Wells M, Mancuso CA, Lee SW, Sonoda T, Michelassi F, Charlson ME, Milsom JW. Identifying important predictors for anastomotic leak after colon and rectal resection: prospective study on 616 patients. Ann Surg. 2013 Jan;257(1):108-13. doi: 10.1097/SLA.0b013e318262a6cd. PMID 22968068
- BACKGROUNDMorse BC, Simpson JP, Jones YR, Johnson BL, Knott BM, Kotrady JA. Determination of independent predictive factors for anastomotic leak: analysis of 682 intestinal anastomoses. Am J Surg. 2013 Dec;206(6):950-5; discussion 955-6. doi: 10.1016/j.amjsurg.2013.07.017. Epub 2013 Sep 24. PMID 24070663
- BACKGROUNDMirnezami A, Mirnezami R, Chandrakumaran K, Sasapu K, Sagar P, Finan P. Increased local recurrence and reduced survival from colorectal cancer following anastomotic leak: systematic review and meta-analysis. Ann Surg. 2011 May;253(5):890-9. doi: 10.1097/SLA.0b013e3182128929. PMID 21394013
- BACKGROUNDRoumen 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