Clinical trial · Interventional
Side-to-end Anastomosis Versus Colon J Pouch for Reconstruction After Low Anterior Resection for Rectal Cancer (SAVE)
NCT01006577CI-TRIAL-00002760SAVEunknownN/AClinicalTrials.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)
Primary hypothesis: Side-to-end anastomosis is non-inferior to colon J pouch for reconstruction after low anterior resection for rectal cancer in fecal incontinence (Wexner score). Research questions: Are there differences between side-to-end anastomosis and colon J pouch in * bowel function (fecal incontinence, frequency of bowel movements, rectal urgency, incomplete evacuation) * quality of life * sexual function * urinary function * postoperative complications * operation time/ institutional costs
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 Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| colon j pouch | Procedure | — | UNRESOLVED |
| side-to-end anastomosis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- colon j pouch
- description
- Control intervention: Low anterior resection for rectal cancer with total mesorectal excision (TME), ligation of the inferior mesenteric artery, mobilization of the splenic flexure, radical lymph node dissection and colon J pouch rectal/colon J pouch anal anastomosis (CJP). The colon J Pouch is formed by the descending colon by stapling. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.
- interventionNames
- Procedure: colon j pouch
- type
- EXPERIMENTAL
- label
- side-to-end anastomosis (STE)
- description
- Experimental intervention: Low anterior resection for rectal cancer \< 12 cm from the anal verge with total mesorectal excision (TME), ligation of the inferior mesenteric artery, mobilization of the splenic flexure, radical lymph node dissection and side-to-end colorectal/ coloanal anastomosis (STE). The blind end of the descending colon is closed with a linear stapler. The length of the blind end is measured and the integrity of the anastomosis is tested intraoperatively. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * patients with histological proven middle to low rectal cancer (\< 12 cm from the anal verge) requiring low anterior resection with TME * with or without (neo)-adjuvant radiochemotherapy * age ≥18 years * normal preoperative sphincter status (Wexner score = 0) Exclusion Criteria: * synchronous metastasis * age \> 80 years * previous colon resection * inflammatory bowel disease * previous pelvic malignant tumor * no anterior resection/ TME possible * synchronous other malignant disease * emergency operation * local excision by colonoscopy possible * unability to complete or comprehend the preoperative questionnaire
References
Publications (0)
Data not yet available
No reference posted for this study.